Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis
Identifieur interne : 001548 ( Istex/Corpus ); précédent : 001547; suivant : 001549Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis
Auteurs : P. H. Hofschneider ; U. Winter ; E. M. Lemmel ; B. Brölz ; W. Gaus ; S. Schmid ; H. J. Obert ; C. Stetter ; I. O. Auer ; C. Papst ; W. H. Boesken ; H. E. Stierle Ii ; U. Botzenhardt ; W. Reemtsen ; D. Brackertz ; D. Richter ; V. Diehl ; A. K. Von Kalle ; C. G Rtner ; S. Herzig ; J. Goronzy ; C. Weyand ; J. R. Kalden ; F. Strobel ; K. Machalke ; H. H. Peter ; S. Meske ; M. Schattenkirchner ; K. Krüger ; R. Sprekeler ; H. D. Waller ; J. G. Saal ; H. Warnatz ; G. Lemm ; K. Wilms ; T. StolzenburgSource :
- Rheumatology International [ 0172-8172 ] ; 1992-11-01.
Abstract
Summary: The controlled clinical trial reported here is part of a multicenter clinical and basic research project, sponsored by the German Federal Minister of Science and Technology, directed by a standing commission of the president of the Max-Planck-Gesellschaft, and coordinated by the Max-Planck-Institut für Biochemie, München. Overall, 249 patients with rheumatoid arthritis (RA) were enrolled by 16 participating hospitals. In addition to NSAID treatment, patients were randomly given either interferon gamma (IFN-γ) or placebo. In the IFN-γ group, 107 patients were evaluated and in the control group, 116 patients were evaluated. The response rate after 3 months of treatment, according to joint pain indexes, was significantly higher in the IFN-γ group with an error probability of 1%. IFN-γ was able to reduce the quantity of corticosteroids administered. Compared with the control group, the IFN-γ group benefited considering all parameters measured. Most important side effects were transient fever and transient influenza-like symptoms; all other adverse events were comparable in both groups.
Url:
DOI: 10.1007/BF00302149
Links to Exploration step
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<author><name sortKey="Winter, U" sort="Winter, U" uniqKey="Winter U" first="U." last="Winter">U. Winter</name>
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<author><name sortKey="Lemmel, E M" sort="Lemmel, E M" uniqKey="Lemmel E" first="E. M." last="Lemmel">E. M. Lemmel</name>
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<author><name sortKey="Brolz, B" sort="Brolz, B" uniqKey="Brolz B" first="B." last="Brölz">B. Brölz</name>
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<author><name sortKey="Gaus, W" sort="Gaus, W" uniqKey="Gaus W" first="W." last="Gaus">W. Gaus</name>
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<author><name sortKey="Schmid, S" sort="Schmid, S" uniqKey="Schmid S" first="S." last="Schmid">S. Schmid</name>
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<author><name sortKey="Obert, H J" sort="Obert, H J" uniqKey="Obert H" first="H. J." last="Obert">H. J. Obert</name>
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<author><name sortKey="Stetter, C" sort="Stetter, C" uniqKey="Stetter C" first="C." last="Stetter">C. Stetter</name>
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<author><name sortKey="Boesken, W H" sort="Boesken, W H" uniqKey="Boesken W" first="W. H." last="Boesken">W. H. Boesken</name>
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<author><name sortKey="Stierle Ii, H E" sort="Stierle Ii, H E" uniqKey="Stierle Ii H" first="H. E." last="Stierle Ii">H. E. Stierle Ii</name>
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<author><name sortKey="Botzenhardt, U" sort="Botzenhardt, U" uniqKey="Botzenhardt U" first="U." last="Botzenhardt">U. Botzenhardt</name>
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<author><name sortKey="Reemtsen, W" sort="Reemtsen, W" uniqKey="Reemtsen W" first="W." last="Reemtsen">W. Reemtsen</name>
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<author><name sortKey="Brackertz, D" sort="Brackertz, D" uniqKey="Brackertz D" first="D." last="Brackertz">D. Brackertz</name>
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<author><name sortKey="Richter, D" sort="Richter, D" uniqKey="Richter D" first="D." last="Richter">D. Richter</name>
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<author><name sortKey="Diehl, V" sort="Diehl, V" uniqKey="Diehl V" first="V." last="Diehl">V. Diehl</name>
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<author><name sortKey="Von Kalle, A K" sort="Von Kalle, A K" uniqKey="Von Kalle A" first="A. K." last="Von Kalle">A. K. Von Kalle</name>
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<author><name sortKey="G Rtner, C" sort="G Rtner, C" uniqKey="G Rtner C" first="C." last="G Rtner">C. G Rtner</name>
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<author><name sortKey="Herzig, S" sort="Herzig, S" uniqKey="Herzig S" first="S." last="Herzig">S. Herzig</name>
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<author><name sortKey="Goronzy, J" sort="Goronzy, J" uniqKey="Goronzy J" first="J." last="Goronzy">J. Goronzy</name>
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<author><name sortKey="Weyand, C" sort="Weyand, C" uniqKey="Weyand C" first="C." last="Weyand">C. Weyand</name>
<affiliation><mods:affiliation>Medizinische Poliklinik V Heidelberg, Heidelberg, Germany</mods:affiliation>
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<author><name sortKey="Kalden, J R" sort="Kalden, J R" uniqKey="Kalden J" first="J. R." last="Kalden">J. R. Kalden</name>
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<author><name sortKey="Strobel, F" sort="Strobel, F" uniqKey="Strobel F" first="F." last="Strobel">F. Strobel</name>
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<author><name sortKey="Machalke, K" sort="Machalke, K" uniqKey="Machalke K" first="K." last="Machalke">K. Machalke</name>
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<author><name sortKey="Peter, H H" sort="Peter, H H" uniqKey="Peter H" first="H. H." last="Peter">H. H. Peter</name>
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<author><name sortKey="Meske, S" sort="Meske, S" uniqKey="Meske S" first="S." last="Meske">S. Meske</name>
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<author><name sortKey="Schattenkirchner, M" sort="Schattenkirchner, M" uniqKey="Schattenkirchner M" first="M." last="Schattenkirchner">M. Schattenkirchner</name>
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<author><name sortKey="Kruger, K" sort="Kruger, K" uniqKey="Kruger K" first="K." last="Krüger">K. Krüger</name>
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<author><name sortKey="Sprekeler, R" sort="Sprekeler, R" uniqKey="Sprekeler R" first="R." last="Sprekeler">R. Sprekeler</name>
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<author><name sortKey="Waller, H D" sort="Waller, H D" uniqKey="Waller H" first="H. D." last="Waller">H. D. Waller</name>
<affiliation><mods:affiliation>Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany</mods:affiliation>
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<author><name sortKey="Saal, J G" sort="Saal, J G" uniqKey="Saal J" first="J. G." last="Saal">J. G. Saal</name>
<affiliation><mods:affiliation>Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany</mods:affiliation>
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<author><name sortKey="Warnatz, H" sort="Warnatz, H" uniqKey="Warnatz H" first="H." last="Warnatz">H. Warnatz</name>
<affiliation><mods:affiliation>Katholisches Krankenhaus Essen-Werden, Essen, Germany</mods:affiliation>
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<author><name sortKey="Lemm, G" sort="Lemm, G" uniqKey="Lemm G" first="G." last="Lemm">G. Lemm</name>
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<author><name sortKey="Wilms, K" sort="Wilms, K" uniqKey="Wilms K" first="K." last="Wilms">K. Wilms</name>
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<author><name sortKey="Stolzenburg, T" sort="Stolzenburg, T" uniqKey="Stolzenburg T" first="T." last="Stolzenburg">T. Stolzenburg</name>
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<sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis</title>
<author><name sortKey="Hofschneider, P H" sort="Hofschneider, P H" uniqKey="Hofschneider P" first="P. H." last="Hofschneider">P. H. Hofschneider</name>
<affiliation><mods:affiliation>Max-Planck-Institut für Biochemie, Martinsried</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Winter, U" sort="Winter, U" uniqKey="Winter U" first="U." last="Winter">U. Winter</name>
<affiliation><mods:affiliation>Max-Planck-Institut für Biochemie, Martinsried</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Lemmel, E M" sort="Lemmel, E M" uniqKey="Lemmel E" first="E. M." last="Lemmel">E. M. Lemmel</name>
<affiliation><mods:affiliation>Staatliches Rheumakrankenhaus Baden-Baden, Baden Baden, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Brolz, B" sort="Brolz, B" uniqKey="Brolz B" first="B." last="Brölz">B. Brölz</name>
<affiliation><mods:affiliation>Staatliches Rheumakrankenhaus Baden-Baden, Baden Baden, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Gaus, W" sort="Gaus, W" uniqKey="Gaus W" first="W." last="Gaus">W. Gaus</name>
<affiliation><mods:affiliation>Universität Ulm, Ulm, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Schmid, S" sort="Schmid, S" uniqKey="Schmid S" first="S." last="Schmid">S. Schmid</name>
<affiliation><mods:affiliation>Universität Ulm, Ulm, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Obert, H J" sort="Obert, H J" uniqKey="Obert H" first="H. J." last="Obert">H. J. Obert</name>
<affiliation><mods:affiliation>Bioferon biochemische Substanzen GmbH & Co., Laupheim</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Stetter, C" sort="Stetter, C" uniqKey="Stetter C" first="C." last="Stetter">C. Stetter</name>
<affiliation><mods:affiliation>Bioferon biochemische Substanzen GmbH & Co., Laupheim</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Auer, I O" sort="Auer, I O" uniqKey="Auer I" first="I. O." last="Auer">I. O. Auer</name>
<affiliation><mods:affiliation>Medizinische Universitätsklinik, Luitpoldkrankenhaus, Würzburg</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Papst, C" sort="Papst, C" uniqKey="Papst C" first="C." last="Papst">C. Papst</name>
<affiliation><mods:affiliation>Medizinische Universitätsklinik, Luitpoldkrankenhaus, Würzburg</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Boesken, W H" sort="Boesken, W H" uniqKey="Boesken W" first="W. H." last="Boesken">W. H. Boesken</name>
<affiliation><mods:affiliation>Medizinische Abteilung, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Stierle Ii, H E" sort="Stierle Ii, H E" uniqKey="Stierle Ii H" first="H. E." last="Stierle Ii">H. E. Stierle Ii</name>
<affiliation><mods:affiliation>Medizinische Abteilung, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Botzenhardt, U" sort="Botzenhardt, U" uniqKey="Botzenhardt U" first="U." last="Botzenhardt">U. Botzenhardt</name>
<affiliation><mods:affiliation>Rheumatologische Abteilung, Rotes Kreuz-Krankenhaus Bremen, Bremen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Reemtsen, W" sort="Reemtsen, W" uniqKey="Reemtsen W" first="W." last="Reemtsen">W. Reemtsen</name>
<affiliation><mods:affiliation>Rheumatologische Abteilung, Rotes Kreuz-Krankenhaus Bremen, Bremen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Brackertz, D" sort="Brackertz, D" uniqKey="Brackertz D" first="D." last="Brackertz">D. Brackertz</name>
<affiliation><mods:affiliation>St. Vincenz- und Elisabeth-Hospital Mainz, Mainz, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Richter, D" sort="Richter, D" uniqKey="Richter D" first="D." last="Richter">D. Richter</name>
<affiliation><mods:affiliation>St. Vincenz- und Elisabeth-Hospital Mainz, Mainz, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Diehl, V" sort="Diehl, V" uniqKey="Diehl V" first="V." last="Diehl">V. Diehl</name>
<affiliation><mods:affiliation>Medizinische Universitätsklinik Köln, Koln, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Von Kalle, A K" sort="Von Kalle, A K" uniqKey="Von Kalle A" first="A. K." last="Von Kalle">A. K. Von Kalle</name>
<affiliation><mods:affiliation>Medizinische Universitätsklinik Köln, Koln, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="G Rtner, C" sort="G Rtner, C" uniqKey="G Rtner C" first="C." last="G Rtner">C. G Rtner</name>
<affiliation><mods:affiliation>Krankenhaus Porz/Rhein, Abteilung Rheumatologie, Köln</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Herzig, S" sort="Herzig, S" uniqKey="Herzig S" first="S." last="Herzig">S. Herzig</name>
<affiliation><mods:affiliation>Krankenhaus Porz/Rhein, Abteilung Rheumatologie, Köln</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Goronzy, J" sort="Goronzy, J" uniqKey="Goronzy J" first="J." last="Goronzy">J. Goronzy</name>
<affiliation><mods:affiliation>Medizinische Poliklinik V Heidelberg, Heidelberg, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Weyand, C" sort="Weyand, C" uniqKey="Weyand C" first="C." last="Weyand">C. Weyand</name>
<affiliation><mods:affiliation>Medizinische Poliklinik V Heidelberg, Heidelberg, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Kalden, J R" sort="Kalden, J R" uniqKey="Kalden J" first="J. R." last="Kalden">J. R. Kalden</name>
<affiliation><mods:affiliation>Medizinische Klinik III und Institut für klinische Immunologie und Rheumatologie Erlangen, Erlangen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Strobel, F" sort="Strobel, F" uniqKey="Strobel F" first="F." last="Strobel">F. Strobel</name>
<affiliation><mods:affiliation>Medizinische Klinik III und Institut für klinische Immunologie und Rheumatologie Erlangen, Erlangen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Machalke, K" sort="Machalke, K" uniqKey="Machalke K" first="K." last="Machalke">K. Machalke</name>
<affiliation><mods:affiliation>Klinik Lippe, Horn-Bad Meinberg</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Peter, H H" sort="Peter, H H" uniqKey="Peter H" first="H. H." last="Peter">H. H. Peter</name>
<affiliation><mods:affiliation>Abteilung Rheumatologie und klinische Immunologie, Medizinische Universitätsklinik Freiburg, Freiburg, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Meske, S" sort="Meske, S" uniqKey="Meske S" first="S." last="Meske">S. Meske</name>
<affiliation><mods:affiliation>Abteilung Rheumatologie und klinische Immunologie, Medizinische Universitätsklinik Freiburg, Freiburg, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Schattenkirchner, M" sort="Schattenkirchner, M" uniqKey="Schattenkirchner M" first="M." last="Schattenkirchner">M. Schattenkirchner</name>
<affiliation><mods:affiliation>Rheumaeinheit, Medizinische Poliklinik der Universität München, Munchen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Kruger, K" sort="Kruger, K" uniqKey="Kruger K" first="K." last="Krüger">K. Krüger</name>
<affiliation><mods:affiliation>Rheumaeinheit, Medizinische Poliklinik der Universität München, Munchen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Sprekeler, R" sort="Sprekeler, R" uniqKey="Sprekeler R" first="R." last="Sprekeler">R. Sprekeler</name>
<affiliation><mods:affiliation>Diakoniekrankenhaus Rotenburg/Wümme, Rotenburg/Wümme, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Waller, H D" sort="Waller, H D" uniqKey="Waller H" first="H. D." last="Waller">H. D. Waller</name>
<affiliation><mods:affiliation>Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Saal, J G" sort="Saal, J G" uniqKey="Saal J" first="J. G." last="Saal">J. G. Saal</name>
<affiliation><mods:affiliation>Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Warnatz, H" sort="Warnatz, H" uniqKey="Warnatz H" first="H." last="Warnatz">H. Warnatz</name>
<affiliation><mods:affiliation>Katholisches Krankenhaus Essen-Werden, Essen, Germany</mods:affiliation>
</affiliation>
</author>
<author><name sortKey="Lemm, G" sort="Lemm, G" uniqKey="Lemm G" first="G." last="Lemm">G. Lemm</name>
<affiliation><mods:affiliation>Katholisches Krankenhaus Essen-Werden, Essen, Germany</mods:affiliation>
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<front><div type="abstract" xml:lang="en">Summary: The controlled clinical trial reported here is part of a multicenter clinical and basic research project, sponsored by the German Federal Minister of Science and Technology, directed by a standing commission of the president of the Max-Planck-Gesellschaft, and coordinated by the Max-Planck-Institut für Biochemie, München. Overall, 249 patients with rheumatoid arthritis (RA) were enrolled by 16 participating hospitals. In addition to NSAID treatment, patients were randomly given either interferon gamma (IFN-γ) or placebo. In the IFN-γ group, 107 patients were evaluated and in the control group, 116 patients were evaluated. The response rate after 3 months of treatment, according to joint pain indexes, was significantly higher in the IFN-γ group with an error probability of 1%. IFN-γ was able to reduce the quantity of corticosteroids administered. Compared with the control group, the IFN-γ group benefited considering all parameters measured. Most important side effects were transient fever and transient influenza-like symptoms; all other adverse events were comparable in both groups.</div>
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<author xml:id="author-4" corresp="yes"><persName><forename type="first">E.</forename>
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<author xml:id="author-6"><persName><forename type="first">W.</forename>
<surname>Gaus</surname>
</persName>
<affiliation>Universität Ulm, Ulm, Germany</affiliation>
</author>
<author xml:id="author-7"><persName><forename type="first">S.</forename>
<surname>Schmid</surname>
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<author xml:id="author-8"><persName><forename type="first">H.</forename>
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<affiliation>Bioferon biochemische Substanzen GmbH & Co., Laupheim</affiliation>
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<author xml:id="author-9"><persName><forename type="first">C.</forename>
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<author xml:id="author-10"><persName><forename type="first">I.</forename>
<surname>Auer</surname>
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<affiliation>Medizinische Universitätsklinik, Luitpoldkrankenhaus, Würzburg</affiliation>
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<surname>Papst</surname>
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<author xml:id="author-12"><persName><forename type="first">W.</forename>
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<author xml:id="author-13"><persName><forename type="first">H.</forename>
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<author xml:id="author-14"><persName><forename type="first">U.</forename>
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<author xml:id="author-15"><persName><forename type="first">W.</forename>
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<author xml:id="author-16"><persName><forename type="first">D.</forename>
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<affiliation>St. Vincenz- und Elisabeth-Hospital Mainz, Mainz, Germany</affiliation>
</author>
<author xml:id="author-17"><persName><forename type="first">D.</forename>
<surname>Richter</surname>
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<affiliation>St. Vincenz- und Elisabeth-Hospital Mainz, Mainz, Germany</affiliation>
</author>
<author xml:id="author-18"><persName><forename type="first">V.</forename>
<surname>Diehl</surname>
</persName>
<affiliation>Medizinische Universitätsklinik Köln, Koln, Germany</affiliation>
</author>
<author xml:id="author-19"><persName><forename type="first">A.</forename>
<surname>von Kalle</surname>
</persName>
<affiliation>Medizinische Universitätsklinik Köln, Koln, Germany</affiliation>
</author>
<author xml:id="author-20"><persName><forename type="first">C.</forename>
<surname>Gärtner</surname>
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<affiliation>Krankenhaus Porz/Rhein, Abteilung Rheumatologie, Köln</affiliation>
</author>
<author xml:id="author-21"><persName><forename type="first">S.</forename>
<surname>Herzig</surname>
</persName>
<affiliation>Krankenhaus Porz/Rhein, Abteilung Rheumatologie, Köln</affiliation>
</author>
<author xml:id="author-22"><persName><forename type="first">J.</forename>
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<affiliation>Medizinische Poliklinik V Heidelberg, Heidelberg, Germany</affiliation>
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<author xml:id="author-23"><persName><forename type="first">C.</forename>
<surname>Weyand</surname>
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<affiliation>Medizinische Poliklinik V Heidelberg, Heidelberg, Germany</affiliation>
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<author xml:id="author-24"><persName><forename type="first">J.</forename>
<surname>Kalden</surname>
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<affiliation>Medizinische Klinik III und Institut für klinische Immunologie und Rheumatologie Erlangen, Erlangen, Germany</affiliation>
</author>
<author xml:id="author-25"><persName><forename type="first">F.</forename>
<surname>Strobel</surname>
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</author>
<author xml:id="author-26"><persName><forename type="first">K.</forename>
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<affiliation>Klinik Lippe, Horn-Bad Meinberg</affiliation>
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<author xml:id="author-27"><persName><forename type="first">H.</forename>
<surname>Peter</surname>
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<affiliation>Abteilung Rheumatologie und klinische Immunologie, Medizinische Universitätsklinik Freiburg, Freiburg, Germany</affiliation>
</author>
<author xml:id="author-28"><persName><forename type="first">S.</forename>
<surname>Meske</surname>
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<affiliation>Abteilung Rheumatologie und klinische Immunologie, Medizinische Universitätsklinik Freiburg, Freiburg, Germany</affiliation>
</author>
<author xml:id="author-29"><persName><forename type="first">M.</forename>
<surname>Schattenkirchner</surname>
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<affiliation>Rheumaeinheit, Medizinische Poliklinik der Universität München, Munchen, Germany</affiliation>
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<author xml:id="author-30"><persName><forename type="first">K.</forename>
<surname>Krüger</surname>
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<affiliation>Rheumaeinheit, Medizinische Poliklinik der Universität München, Munchen, Germany</affiliation>
</author>
<author xml:id="author-31"><persName><forename type="first">R.</forename>
<surname>Sprekeler</surname>
</persName>
<affiliation>Diakoniekrankenhaus Rotenburg/Wümme, Rotenburg/Wümme, Germany</affiliation>
</author>
<author xml:id="author-32"><persName><forename type="first">H.</forename>
<surname>Waller</surname>
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<affiliation>Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany</affiliation>
</author>
<author xml:id="author-33"><persName><forename type="first">J.</forename>
<surname>Saal</surname>
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<affiliation>Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany</affiliation>
</author>
<author xml:id="author-34"><persName><forename type="first">H.</forename>
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<affiliation>Katholisches Krankenhaus Essen-Werden, Essen, Germany</affiliation>
</author>
<author xml:id="author-35"><persName><forename type="first">G.</forename>
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<author xml:id="author-36"><persName><forename type="first">K.</forename>
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<affiliation>Medizinische Poliklinik der Universität Würzburg, Wurzburg, Germany</affiliation>
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<author xml:id="author-37"><persName><forename type="first">T.</forename>
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<title level="j" type="sub">Clinical and Experimental Investigations</title>
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<abstract xml:lang="en"><p>Summary: The controlled clinical trial reported here is part of a multicenter clinical and basic research project, sponsored by the German Federal Minister of Science and Technology, directed by a standing commission of the president of the Max-Planck-Gesellschaft, and coordinated by the Max-Planck-Institut für Biochemie, München. Overall, 249 patients with rheumatoid arthritis (RA) were enrolled by 16 participating hospitals. In addition to NSAID treatment, patients were randomly given either interferon gamma (IFN-γ) or placebo. In the IFN-γ group, 107 patients were evaluated and in the control group, 116 patients were evaluated. The response rate after 3 months of treatment, according to joint pain indexes, was significantly higher in the IFN-γ group with an error probability of 1%. IFN-γ was able to reduce the quantity of corticosteroids administered. Compared with the control group, the IFN-γ group benefited considering all parameters measured. Most important side effects were transient fever and transient influenza-like symptoms; all other adverse events were comparable in both groups.</p>
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<Author AffiliationIDS="Aff17"><AuthorName DisplayOrder="Western"><GivenName>K.</GivenName>
<FamilyName>Krüger</FamilyName>
</AuthorName>
</Author>
<Author AffiliationIDS="Aff18"><AuthorName DisplayOrder="Western"><GivenName>R.</GivenName>
<FamilyName>Sprekeler</FamilyName>
</AuthorName>
</Author>
<Author AffiliationIDS="Aff19"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName>
<GivenName>D.</GivenName>
<FamilyName>Waller</FamilyName>
</AuthorName>
</Author>
<Author AffiliationIDS="Aff19"><AuthorName DisplayOrder="Western"><GivenName>J.</GivenName>
<GivenName>G.</GivenName>
<FamilyName>Saal</FamilyName>
</AuthorName>
</Author>
<Author AffiliationIDS="Aff20"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName>
<FamilyName>Warnatz</FamilyName>
</AuthorName>
</Author>
<Author AffiliationIDS="Aff20"><AuthorName DisplayOrder="Western"><GivenName>G.</GivenName>
<FamilyName>Lemm</FamilyName>
</AuthorName>
</Author>
<Author AffiliationIDS="Aff21"><AuthorName DisplayOrder="Western"><GivenName>K.</GivenName>
<FamilyName>Wilms</FamilyName>
</AuthorName>
</Author>
<Author AffiliationIDS="Aff21"><AuthorName DisplayOrder="Western"><GivenName>T.</GivenName>
<FamilyName>Stolzenburg</FamilyName>
</AuthorName>
</Author>
<Affiliation ID="Aff1"><OrgName>Max-Planck-Institut für Biochemie</OrgName>
<OrgAddress><City>Martinsried</City>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff2"><OrgName>Staatliches Rheumakrankenhaus Baden-Baden</OrgName>
<OrgAddress><City>Baden Baden</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff4"><OrgName>Universität Ulm</OrgName>
<OrgAddress><City>Ulm</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff5"><OrgName>Bioferon biochemische Substanzen GmbH & Co.</OrgName>
<OrgAddress><City>Laupheim</City>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff6"><OrgName>Medizinische Universitätsklinik</OrgName>
<OrgAddress><Street>Luitpoldkrankenhaus</Street>
<City>Würzburg</City>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff7"><OrgDivision>Medizinische Abteilung</OrgDivision>
<OrgName>Krankenhaus der Barmherzigen Brüder Trier</OrgName>
<OrgAddress><City>Trier</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff8"><OrgName>Rheumatologische Abteilung, Rotes Kreuz-Krankenhaus Bremen</OrgName>
<OrgAddress><City>Bremen</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff9"><OrgName>St. Vincenz- und Elisabeth-Hospital Mainz</OrgName>
<OrgAddress><City>Mainz</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff10"><OrgName>Medizinische Universitätsklinik Köln</OrgName>
<OrgAddress><City>Koln</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff11"><OrgDivision>Krankenhaus Porz/Rhein</OrgDivision>
<OrgName>Abteilung Rheumatologie</OrgName>
<OrgAddress><City>Köln</City>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff12"><OrgName>Medizinische Poliklinik V Heidelberg</OrgName>
<OrgAddress><City>Heidelberg</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff13"><OrgName>Medizinische Klinik III und Institut für klinische Immunologie und Rheumatologie Erlangen</OrgName>
<OrgAddress><City>Erlangen</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff15"><OrgName>Klinik Lippe</OrgName>
<OrgAddress><City>Horn-Bad Meinberg</City>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff16"><OrgDivision>Abteilung Rheumatologie und klinische Immunologie</OrgDivision>
<OrgName>Medizinische Universitätsklinik Freiburg</OrgName>
<OrgAddress><City>Freiburg</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff17"><OrgDivision>Rheumaeinheit</OrgDivision>
<OrgName>Medizinische Poliklinik der Universität München</OrgName>
<OrgAddress><City>Munchen</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff18"><OrgName>Diakoniekrankenhaus Rotenburg/Wümme</OrgName>
<OrgAddress><City>Rotenburg/Wümme</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff19"><OrgDivision>Abteilung Innere Medizin II</OrgDivision>
<OrgName>Medizinische Klinik Tübingen</OrgName>
<OrgAddress><City>Tubingen</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff20"><OrgName>Katholisches Krankenhaus Essen-Werden</OrgName>
<OrgAddress><City>Essen</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff21"><OrgName>Medizinische Poliklinik der Universität Würzburg</OrgName>
<OrgAddress><City>Wurzburg</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
<Affiliation ID="Aff3"><OrgName>Staatliches Rheumakrankenhaus</OrgName>
<OrgAddress><Street>Rotenbachtalstrasse 5</Street>
<Postcode>W-7570</Postcode>
<City>Baden-Baden</City>
<Country>Germany</Country>
</OrgAddress>
</Affiliation>
</AuthorGroup>
<Abstract ID="Abs1" Language="En"><Heading>Summary</Heading>
<Para>The controlled clinical trial reported here is part of a multicenter clinical and basic research project, sponsored by the German Federal Minister of Science and Technology, directed by a standing commission of the president of the Max-Planck-Gesellschaft, and coordinated by the Max-Planck-Institut für Biochemie, München. Overall, 249 patients with rheumatoid arthritis (RA) were enrolled by 16 participating hospitals. In addition to NSAID treatment, patients were randomly given either interferon gamma (IFN-γ) or placebo. In the IFN-γ group, 107 patients were evaluated and in the control group, 116 patients were evaluated. The response rate after 3 months of treatment, according to joint pain indexes, was significantly higher in the IFN-γ group with an error probability of 1%. IFN-γ was able to reduce the quantity of corticosteroids administered. Compared with the control group, the IFN-γ group benefited considering all parameters measured. Most important side effects were transient fever and transient influenza-like symptoms; all other adverse events were comparable in both groups.</Para>
</Abstract>
<KeywordGroup Language="En"><Heading>Key words</Heading>
<Keyword>Interferon gamma</Keyword>
<Keyword>Rheumatoid arthritis</Keyword>
<Keyword>Controlled clinical trial</Keyword>
<Keyword>Multicenter</Keyword>
</KeywordGroup>
</ArticleHeader>
<NoBody></NoBody>
</Article>
</Issue>
</Volume>
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<mods version="3.6"><titleInfo lang="en"><title>Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis</title>
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<titleInfo type="alternative" contentType="CDATA" lang="en"><title>Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis</title>
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<name type="corporate"><namePart>German Lymphokine Study Group</namePart>
</name>
<name type="personal"><namePart type="given">P.</namePart>
<namePart type="given">H.</namePart>
<namePart type="family">Hofschneider</namePart>
<affiliation>Max-Planck-Institut für Biochemie, Martinsried</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">U.</namePart>
<namePart type="family">Winter</namePart>
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</name>
<name type="personal" displayLabel="corresp"><namePart type="given">E.</namePart>
<namePart type="given">-M.</namePart>
<namePart type="family">Lemmel</namePart>
<affiliation>Staatliches Rheumakrankenhaus Baden-Baden, Baden Baden, Germany</affiliation>
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</name>
<name type="personal"><namePart type="given">B.</namePart>
<namePart type="family">Brölz</namePart>
<affiliation>Staatliches Rheumakrankenhaus Baden-Baden, Baden Baden, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
<description>main investigator</description>
</name>
<name type="personal"><namePart type="given">W.</namePart>
<namePart type="family">Gaus</namePart>
<affiliation>Universität Ulm, Ulm, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">S.</namePart>
<namePart type="family">Schmid</namePart>
<affiliation>Universität Ulm, Ulm, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">H.</namePart>
<namePart type="given">-J.</namePart>
<namePart type="family">Obert</namePart>
<affiliation>Bioferon biochemische Substanzen GmbH & Co., Laupheim</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">C.</namePart>
<namePart type="family">Stetter</namePart>
<affiliation>Bioferon biochemische Substanzen GmbH & Co., Laupheim</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">I.</namePart>
<namePart type="given">O.</namePart>
<namePart type="family">Auer</namePart>
<affiliation>Medizinische Universitätsklinik, Luitpoldkrankenhaus, Würzburg</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">C.</namePart>
<namePart type="family">Papst</namePart>
<affiliation>Medizinische Universitätsklinik, Luitpoldkrankenhaus, Würzburg</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">W.</namePart>
<namePart type="given">H.</namePart>
<namePart type="family">Boesken</namePart>
<affiliation>Medizinische Abteilung, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">H.</namePart>
<namePart type="given">E.</namePart>
<namePart type="family">Stierle II</namePart>
<affiliation>Medizinische Abteilung, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">U.</namePart>
<namePart type="family">Botzenhardt</namePart>
<affiliation>Rheumatologische Abteilung, Rotes Kreuz-Krankenhaus Bremen, Bremen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">W.</namePart>
<namePart type="family">Reemtsen</namePart>
<affiliation>Rheumatologische Abteilung, Rotes Kreuz-Krankenhaus Bremen, Bremen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">D.</namePart>
<namePart type="family">Brackertz</namePart>
<affiliation>St. Vincenz- und Elisabeth-Hospital Mainz, Mainz, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">D.</namePart>
<namePart type="family">Richter</namePart>
<affiliation>St. Vincenz- und Elisabeth-Hospital Mainz, Mainz, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">V.</namePart>
<namePart type="family">Diehl</namePart>
<affiliation>Medizinische Universitätsklinik Köln, Koln, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">A.</namePart>
<namePart type="given">K.</namePart>
<namePart type="family">von Kalle</namePart>
<affiliation>Medizinische Universitätsklinik Köln, Koln, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">C.</namePart>
<namePart type="family">Gärtner</namePart>
<affiliation>Krankenhaus Porz/Rhein, Abteilung Rheumatologie, Köln</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">S.</namePart>
<namePart type="family">Herzig</namePart>
<affiliation>Krankenhaus Porz/Rhein, Abteilung Rheumatologie, Köln</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">J.</namePart>
<namePart type="family">Goronzy</namePart>
<affiliation>Medizinische Poliklinik V Heidelberg, Heidelberg, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">C.</namePart>
<namePart type="family">Weyand</namePart>
<affiliation>Medizinische Poliklinik V Heidelberg, Heidelberg, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">J.</namePart>
<namePart type="given">R.</namePart>
<namePart type="family">Kalden</namePart>
<affiliation>Medizinische Klinik III und Institut für klinische Immunologie und Rheumatologie Erlangen, Erlangen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">F.</namePart>
<namePart type="family">Strobel</namePart>
<affiliation>Medizinische Klinik III und Institut für klinische Immunologie und Rheumatologie Erlangen, Erlangen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">K.</namePart>
<namePart type="family">Machalke</namePart>
<affiliation>Klinik Lippe, Horn-Bad Meinberg</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">H.</namePart>
<namePart type="given">H.</namePart>
<namePart type="family">Peter</namePart>
<affiliation>Abteilung Rheumatologie und klinische Immunologie, Medizinische Universitätsklinik Freiburg, Freiburg, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">S.</namePart>
<namePart type="family">Meske</namePart>
<affiliation>Abteilung Rheumatologie und klinische Immunologie, Medizinische Universitätsklinik Freiburg, Freiburg, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">M.</namePart>
<namePart type="family">Schattenkirchner</namePart>
<affiliation>Rheumaeinheit, Medizinische Poliklinik der Universität München, Munchen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">K.</namePart>
<namePart type="family">Krüger</namePart>
<affiliation>Rheumaeinheit, Medizinische Poliklinik der Universität München, Munchen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">R.</namePart>
<namePart type="family">Sprekeler</namePart>
<affiliation>Diakoniekrankenhaus Rotenburg/Wümme, Rotenburg/Wümme, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">H.</namePart>
<namePart type="given">D.</namePart>
<namePart type="family">Waller</namePart>
<affiliation>Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
</role>
</name>
<name type="personal"><namePart type="given">J.</namePart>
<namePart type="given">G.</namePart>
<namePart type="family">Saal</namePart>
<affiliation>Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany</affiliation>
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</role>
</name>
<name type="personal"><namePart type="given">H.</namePart>
<namePart type="family">Warnatz</namePart>
<affiliation>Katholisches Krankenhaus Essen-Werden, Essen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
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</name>
<name type="personal"><namePart type="given">G.</namePart>
<namePart type="family">Lemm</namePart>
<affiliation>Katholisches Krankenhaus Essen-Werden, Essen, Germany</affiliation>
<role><roleTerm type="text">author</roleTerm>
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<name type="personal"><namePart type="given">K.</namePart>
<namePart type="family">Wilms</namePart>
<affiliation>Medizinische Poliklinik der Universität Würzburg, Wurzburg, Germany</affiliation>
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</name>
<name type="personal"><namePart type="given">T.</namePart>
<namePart type="family">Stolzenburg</namePart>
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<dateCreated encoding="w3cdtf">1992-07-01</dateCreated>
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<abstract lang="en">Summary: The controlled clinical trial reported here is part of a multicenter clinical and basic research project, sponsored by the German Federal Minister of Science and Technology, directed by a standing commission of the president of the Max-Planck-Gesellschaft, and coordinated by the Max-Planck-Institut für Biochemie, München. Overall, 249 patients with rheumatoid arthritis (RA) were enrolled by 16 participating hospitals. In addition to NSAID treatment, patients were randomly given either interferon gamma (IFN-γ) or placebo. In the IFN-γ group, 107 patients were evaluated and in the control group, 116 patients were evaluated. The response rate after 3 months of treatment, according to joint pain indexes, was significantly higher in the IFN-γ group with an error probability of 1%. IFN-γ was able to reduce the quantity of corticosteroids administered. Compared with the control group, the IFN-γ group benefited considering all parameters measured. Most important side effects were transient fever and transient influenza-like symptoms; all other adverse events were comparable in both groups.</abstract>
<note>Originals</note>
<relatedItem type="host"><titleInfo><title>Rheumatology International</title>
<subTitle>Clinical and Experimental Investigations</subTitle>
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<titleInfo type="abbreviated"><title>Rheumatol Int</title>
</titleInfo>
<genre type="journal" displayLabel="Archive Journal"></genre>
<originInfo><dateIssued encoding="w3cdtf">1992-11-01</dateIssued>
<copyrightDate encoding="w3cdtf">1992</copyrightDate>
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<subject><genre>Medicine & Public Health</genre>
<topic>Rheumatology</topic>
</subject>
<identifier type="ISSN">0172-8172</identifier>
<identifier type="eISSN">1437-160X</identifier>
<identifier type="JournalID">296</identifier>
<identifier type="IssueArticleCount">9</identifier>
<identifier type="VolumeIssueCount">6</identifier>
<part><date>1992</date>
<detail type="volume"><number>12</number>
<caption>vol.</caption>
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<detail type="issue"><number>5</number>
<caption>no.</caption>
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<extent unit="pages"><start>175</start>
<end>185</end>
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