Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma
Identifieur interne : 001404 ( Istex/Corpus ); précédent : 001403; suivant : 001405Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma
Auteurs : E. M. Lemmel ; D. Brackertz ; M. Franke ; W. Gaus ; P. W. Hartl ; K. Machalke ; H. Mielke ; H. J. Obert ; H. H. Peter ; J. Sieper ; R. Sprekeler ; H. StierleSource :
- Rheumatology International [ 0172-8172 ] ; 1988-04-01.
Abstract
Summary: In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 μg daily for 20 days, then 50 μg each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie “joint pain index” or Lansbury “joint pain index” by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of a<1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3°C on average, but was below 37.2°C at all times.
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DOI: 10.1007/BF00271840
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma</title><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, 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, Germany</mods:affiliation></affiliation></author><author><name sortKey="Franke, M" sort="Franke, M" uniqKey="Franke M" first="M." last="Franke">M. Franke</name><affiliation><mods:affiliation>Staatliches Rheumakrankenhaus, 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, Klinische Dokumentation, Ulm, Germany</mods:affiliation></affiliation></author><author><name sortKey="Hartl, P W" sort="Hartl, P W" uniqKey="Hartl P" first="P. W." last="Hartl">P. W. Hartl</name><affiliation><mods:affiliation>Rheumaklinik und Rheumaforschungsinstitut, Aachen, 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>Kurklinik Lippe, Horn-Bad Meinberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Mielke, H" sort="Mielke, H" uniqKey="Mielke H" first="H." last="Mielke">H. Mielke</name><affiliation><mods:affiliation>Medizinische Hochschule, Hannover, 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., Postfach 302, D-7958, Laupheim, Germany</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>Medizinische Universitätsklinik, Abt. Rheumatologie, Freiburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Sieper, J" sort="Sieper, J" uniqKey="Sieper J" first="J." last="Sieper">J. Sieper</name><affiliation><mods:affiliation>Universitätsklinikum Steglitz, Berlin, Germany</mods:affiliation></affiliation></author><author><name sortKey="Sprekeler, R" sort="Sprekeler, R" uniqKey="Sprekeler R" first="R." last="Sprekeler">R. 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Lemmel</name><affiliation><mods:affiliation>Staatliches Rheumakrankenhaus, Baden-Baden, 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, Germany</mods:affiliation></affiliation></author><author><name sortKey="Franke, M" sort="Franke, M" uniqKey="Franke M" first="M." last="Franke">M. Franke</name><affiliation><mods:affiliation>Staatliches Rheumakrankenhaus, 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, Klinische Dokumentation, Ulm, Germany</mods:affiliation></affiliation></author><author><name sortKey="Hartl, P W" sort="Hartl, P W" uniqKey="Hartl P" first="P. W." last="Hartl">P. W. Hartl</name><affiliation><mods:affiliation>Rheumaklinik und Rheumaforschungsinstitut, Aachen, 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>Kurklinik Lippe, Horn-Bad Meinberg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Mielke, H" sort="Mielke, H" uniqKey="Mielke H" first="H." last="Mielke">H. Mielke</name><affiliation><mods:affiliation>Medizinische Hochschule, Hannover, 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., Postfach 302, D-7958, Laupheim, Germany</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>Medizinische Universitätsklinik, Abt. Rheumatologie, Freiburg, Germany</mods:affiliation></affiliation></author><author><name sortKey="Sieper, J" sort="Sieper, J" uniqKey="Sieper J" first="J." last="Sieper">J. Sieper</name><affiliation><mods:affiliation>Universitätsklinikum Steglitz, Berlin, 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>Staatliches Rheumakrankenhaus, Wildbad, Germany</mods:affiliation></affiliation></author><author><name sortKey="Stierle, H" sort="Stierle, H" uniqKey="Stierle H" first="H." last="Stierle">H. Stierle</name><affiliation><mods:affiliation>Brüderkrankenhaus, 2. Medizinische Abteilung, Trier, Germany</mods:affiliation></affiliation></author></analytic><monogr></monogr><series><title level="j">Rheumatology International</title><title level="j" type="sub">Clinical and Experimental Investigations</title><title level="j" type="abbrev">Rheumatol Int</title><idno type="ISSN">0172-8172</idno><idno type="eISSN">1437-160X</idno><imprint><publisher>Springer-Verlag</publisher><pubPlace>Berlin/Heidelberg</pubPlace><date type="published" when="1988-04-01">1988-04-01</date><biblScope unit="volume">8</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="87">87</biblScope><biblScope unit="page" to="93">93</biblScope></imprint><idno type="ISSN">0172-8172</idno></series><idno type="istex">1ADC94078E14EE49BBF3C2632BFBB82DE262C811</idno><idno type="DOI">10.1007/BF00271840</idno><idno type="ArticleID">BF00271840</idno><idno type="ArticleID">Art7</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0172-8172</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Summary: In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 μg daily for 20 days, then 50 μg each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie “joint pain index” or Lansbury “joint pain index” by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of a<1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3°C on average, but was below 37.2°C at all times.</div></front></TEI><istex><corpusName>springer</corpusName><author><json:item><name>E. M. Lemmel</name><affiliations><json:string>Staatliches Rheumakrankenhaus, Baden-Baden, Germany</json:string></affiliations></json:item><json:item><name>D. Brackertz</name><affiliations><json:string>St. Vincenz- und Elisabeth-Hospital, Mainz, Germany</json:string></affiliations></json:item><json:item><name>M. Franke</name><affiliations><json:string>Staatliches Rheumakrankenhaus, Baden-Baden, Germany</json:string></affiliations></json:item><json:item><name>W. Gaus</name><affiliations><json:string>Universität Ulm, Klinische Dokumentation, Ulm, Germany</json:string></affiliations></json:item><json:item><name>P. W. Hartl</name><affiliations><json:string>Rheumaklinik und Rheumaforschungsinstitut, Aachen, Germany</json:string></affiliations></json:item><json:item><name>K. Machalke</name><affiliations><json:string>Kurklinik Lippe, Horn-Bad Meinberg, Germany</json:string></affiliations></json:item><json:item><name>H. Mielke</name><affiliations><json:string>Medizinische Hochschule, Hannover, Germany</json:string></affiliations></json:item><json:item><name>H. J. Obert</name><affiliations><json:string>Bioferon biochemische Substanzen GmbH & Co., Postfach 302, D-7958, Laupheim, Germany</json:string></affiliations></json:item><json:item><name>H. H. Peter</name><affiliations><json:string>Medizinische Universitätsklinik, Abt. Rheumatologie, Freiburg, Germany</json:string></affiliations></json:item><json:item><name>J. Sieper</name><affiliations><json:string>Universitätsklinikum Steglitz, Berlin, Germany</json:string></affiliations></json:item><json:item><name>R. Sprekeler</name><affiliations><json:string>Staatliches Rheumakrankenhaus, Wildbad, Germany</json:string></affiliations></json:item><json:item><name>H. Stierle</name><affiliations><json:string>Brüderkrankenhaus, 2. Medizinische Abteilung, Trier, Germany</json:string></affiliations></json:item></author><articleId><json:string>BF00271840</json:string><json:string>Art7</json:string></articleId><language><json:string>eng</json:string></language><originalGenre><json:string>OriginalPaper</json:string></originalGenre><abstract>Summary: In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 μg daily for 20 days, then 50 μg each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie “joint pain index” or Lansbury “joint pain index” by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of a>1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3°C on average, but was below 37.2°C at all times.</abstract><qualityIndicators><score>6.599</score><pdfVersion>1.3</pdfVersion><pdfPageSize>591 x 785 pts</pdfPageSize><refBibsNative>false</refBibsNative><keywordCount>0</keywordCount><abstractCharCount>1250</abstractCharCount><pdfWordCount>4343</pdfWordCount><pdfCharCount>24877</pdfCharCount><pdfPageCount>7</pdfPageCount><abstractWordCount>188</abstractWordCount></qualityIndicators><title>Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma</title><refBibs><json:item><host><pages><last>499</last><first>464</first></pages><author><json:item><name>K Fehr</name></json:item><json:item><name>A Boni</name></json:item></author><title>Gelenke. In: Vorlaender KO (Hrsg) Immunologie. Grundlagen, Klinik, Praxis. 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II. Low levels of synovial fluid and synovial tissue interferon suggest that gamma-interferon is not the primary macrophage activating factor</title><publicationDate>1987</publicationDate></json:item><json:item><author><json:item><name>Mg Malaise</name></json:item><json:item><name>P Franchimont</name></json:item></author><host><volume>30</volume><pages><last>231</last><first>230</first></pages><author></author><title>Arthritis Rheum</title><publicationDate>1987</publicationDate></host><title>Defective in vitro gamma-interferon production in rheumatoid arthritis</title><publicationDate>1987</publicationDate></json:item></refBibs><genre><json:string>research-article</json:string></genre><host><volume>8</volume><pages><last>93</last><first>87</first></pages><issn><json:string>0172-8172</json:string></issn><issue>2</issue><subject><json:item><value>Rheumatology</value></json:item></subject><journalId><json:string>296</json:string></journalId><genre><json:string>journal</json:string></genre><language><json:string>unknown</json:string></language><eissn><json:string>1437-160X</json:string></eissn><title>Rheumatology International</title><publicationDate>1988</publicationDate><copyrightDate>1988</copyrightDate></host><categories><wos><json:string>science</json:string><json:string>rheumatology</json:string></wos><scienceMetrix><json:string>health sciences</json:string><json:string>clinical medicine</json:string><json:string>arthritis & rheumatology</json:string></scienceMetrix></categories><publicationDate>1988</publicationDate><copyrightDate>1988</copyrightDate><doi><json:string>10.1007/BF00271840</json:string></doi><id>1ADC94078E14EE49BBF3C2632BFBB82DE262C811</id><score>0.1919404</score><fulltext><json:item><extension>pdf</extension><original>true</original><mimetype>application/pdf</mimetype><uri>https://api.istex.fr/document/1ADC94078E14EE49BBF3C2632BFBB82DE262C811/fulltext/pdf</uri></json:item><json:item><extension>zip</extension><original>false</original><mimetype>application/zip</mimetype><uri>https://api.istex.fr/document/1ADC94078E14EE49BBF3C2632BFBB82DE262C811/fulltext/zip</uri></json:item><istex:fulltextTEI uri="https://api.istex.fr/document/1ADC94078E14EE49BBF3C2632BFBB82DE262C811/fulltext/tei"><teiHeader><fileDesc><titleStmt><title level="a" type="main" xml:lang="en">Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma</title><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt><respStmt><resp>Références bibliographiques récupérées via GROBID</resp><name resp="ISTEX-API">ISTEX-API (INIST-CNRS)</name></respStmt></titleStmt><publicationStmt><authority>ISTEX</authority><publisher>Springer-Verlag</publisher><pubPlace>Berlin/Heidelberg</pubPlace><availability><p>Springer-Verlag, 1988</p></availability><date>1987-12-09</date></publicationStmt><notesStmt><note>Originals</note></notesStmt><sourceDesc><biblStruct type="inbook"><analytic><title level="a" type="main" xml:lang="en">Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma</title><author xml:id="author-1"><persName><forename type="first">E.</forename><surname>Lemmel</surname></persName><affiliation>Staatliches Rheumakrankenhaus, Baden-Baden, Germany</affiliation></author><author xml:id="author-2"><persName><forename type="first">D.</forename><surname>Brackertz</surname></persName><affiliation>St. Vincenz- und Elisabeth-Hospital, Mainz, Germany</affiliation></author><author xml:id="author-3"><persName><forename type="first">M.</forename><surname>Franke</surname></persName><affiliation>Staatliches Rheumakrankenhaus, Baden-Baden, Germany</affiliation></author><author xml:id="author-4"><persName><forename type="first">W.</forename><surname>Gaus</surname></persName><affiliation>Universität Ulm, Klinische Dokumentation, Ulm, Germany</affiliation></author><author xml:id="author-5"><persName><forename type="first">P.</forename><surname>Hartl</surname></persName><affiliation>Rheumaklinik und Rheumaforschungsinstitut, Aachen, Germany</affiliation></author><author xml:id="author-6"><persName><forename type="first">K.</forename><surname>Machalke</surname></persName><affiliation>Kurklinik Lippe, Horn-Bad Meinberg, Germany</affiliation></author><author xml:id="author-7"><persName><forename type="first">H.</forename><surname>Mielke</surname></persName><affiliation>Medizinische Hochschule, Hannover, Germany</affiliation></author><author xml:id="author-8" corresp="yes"><persName><forename type="first">H.</forename><surname>Obert</surname></persName><affiliation>Bioferon biochemische Substanzen GmbH & Co., Postfach 302, D-7958, Laupheim, Germany</affiliation></author><author xml:id="author-9"><persName><forename type="first">H.</forename><surname>Peter</surname></persName><affiliation>Medizinische Universitätsklinik, Abt. Rheumatologie, Freiburg, Germany</affiliation></author><author xml:id="author-10"><persName><forename type="first">J.</forename><surname>Sieper</surname></persName><affiliation>Universitätsklinikum Steglitz, Berlin, Germany</affiliation></author><author xml:id="author-11"><persName><forename type="first">R.</forename><surname>Sprekeler</surname></persName><affiliation>Staatliches Rheumakrankenhaus, Wildbad, Germany</affiliation></author><author xml:id="author-12"><persName><forename type="first">H.</forename><surname>Stierle</surname></persName><affiliation>Brüderkrankenhaus, 2. Medizinische Abteilung, Trier, Germany</affiliation></author></analytic><monogr><title level="j">Rheumatology International</title><title level="j" type="sub">Clinical and Experimental Investigations</title><title level="j" type="abbrev">Rheumatol Int</title><idno type="journal-ID">296</idno><idno type="pISSN">0172-8172</idno><idno type="eISSN">1437-160X</idno><idno type="issue-article-count">7</idno><idno type="volume-issue-count">6</idno><imprint><publisher>Springer-Verlag</publisher><pubPlace>Berlin/Heidelberg</pubPlace><date type="published" when="1988-04-01"></date><biblScope unit="volume">8</biblScope><biblScope unit="issue">2</biblScope><biblScope unit="page" from="87">87</biblScope><biblScope unit="page" to="93">93</biblScope></imprint></monogr><idno type="istex">1ADC94078E14EE49BBF3C2632BFBB82DE262C811</idno><idno type="DOI">10.1007/BF00271840</idno><idno type="ArticleID">BF00271840</idno><idno type="ArticleID">Art7</idno></biblStruct></sourceDesc></fileDesc><profileDesc><creation><date>1987-12-09</date></creation><langUsage><language ident="en">en</language></langUsage><abstract xml:lang="en"><p>Summary: In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 μg daily for 20 days, then 50 μg each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie “joint pain index” or Lansbury “joint pain index” by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of a<1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3°C on average, but was below 37.2°C at all times.</p></abstract><textClass><keywords scheme="Journal Subject"><list><head>Medicine & Public Health</head><item><term>Rheumatology</term></item></list></keywords></textClass></profileDesc><revisionDesc><change when="1987-12-09">Created</change><change when="1988-04-01">Published</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2016-11-22">References added</change><change xml:id="refBibs-istex" who="#ISTEX-API" when="2017-01-20">References added</change></revisionDesc></teiHeader></istex:fulltextTEI><json:item><extension>txt</extension><original>false</original><mimetype>text/plain</mimetype><uri>https://api.istex.fr/document/1ADC94078E14EE49BBF3C2632BFBB82DE262C811/fulltext/txt</uri></json:item></fulltext><metadata><istex:metadataXml wicri:clean="Springer, Publisher found" wicri:toSee="no header"><istex:xmlDeclaration>version="1.0" encoding="UTF-8"</istex:xmlDeclaration><istex:docType PUBLIC="-//Springer-Verlag//DTD A++ V2.4//EN" URI="http://devel.springer.de/A++/V2.4/DTD/A++V2.4.dtd" name="istex:docType"></istex:docType><istex:document><Publisher><PublisherInfo><PublisherName>Springer-Verlag</PublisherName><PublisherLocation>Berlin/Heidelberg</PublisherLocation></PublisherInfo><Journal><JournalInfo JournalProductType="ArchiveJournal" NumberingStyle="Unnumbered"><JournalID>296</JournalID><JournalPrintISSN>0172-8172</JournalPrintISSN><JournalElectronicISSN>1437-160X</JournalElectronicISSN><JournalTitle>Rheumatology International</JournalTitle><JournalSubTitle>Clinical and Experimental Investigations</JournalSubTitle><JournalAbbreviatedTitle>Rheumatol Int</JournalAbbreviatedTitle><JournalSubjectGroup><JournalSubject Type="Primary">Medicine & Public Health</JournalSubject><JournalSubject Type="Secondary">Rheumatology</JournalSubject></JournalSubjectGroup></JournalInfo><Volume><VolumeInfo VolumeType="Regular" TocLevels="0"><VolumeIDStart>8</VolumeIDStart><VolumeIDEnd>8</VolumeIDEnd><VolumeIssueCount>6</VolumeIssueCount></VolumeInfo><Issue IssueType="Regular"><IssueInfo TocLevels="0"><IssueIDStart>2</IssueIDStart><IssueIDEnd>2</IssueIDEnd><IssueArticleCount>7</IssueArticleCount><IssueHistory><CoverDate><Year>1988</Year><Month>4</Month></CoverDate></IssueHistory><IssueCopyright><CopyrightHolderName>Springer-Verlag</CopyrightHolderName><CopyrightYear>1988</CopyrightYear></IssueCopyright></IssueInfo><Article ID="Art7"><ArticleInfo Language="En" ArticleType="OriginalPaper" NumberingStyle="Unnumbered" TocLevels="0" ContainsESM="No"><ArticleID>BF00271840</ArticleID><ArticleDOI>10.1007/BF00271840</ArticleDOI><ArticleSequenceNumber>7</ArticleSequenceNumber><ArticleTitle Language="En">Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma</ArticleTitle><ArticleCategory>Originals</ArticleCategory><ArticleFirstPage>87</ArticleFirstPage><ArticleLastPage>93</ArticleLastPage><ArticleHistory><RegistrationDate><Year>2004</Year><Month>8</Month><Day>11</Day></RegistrationDate><Received><Year>1987</Year><Month>12</Month><Day>9</Day></Received><Accepted><Year>1988</Year><Month>1</Month><Day>22</Day></Accepted></ArticleHistory><ArticleCopyright><CopyrightHolderName>Springer-Verlag</CopyrightHolderName><CopyrightYear>1988</CopyrightYear></ArticleCopyright><ArticleGrants Type="Regular"><MetadataGrant Grant="OpenAccess"></MetadataGrant><AbstractGrant Grant="OpenAccess"></AbstractGrant><BodyPDFGrant Grant="Restricted"></BodyPDFGrant><BodyHTMLGrant Grant="Restricted"></BodyHTMLGrant><BibliographyGrant Grant="Restricted"></BibliographyGrant><ESMGrant Grant="Restricted"></ESMGrant></ArticleGrants><ArticleContext><JournalID>296</JournalID><VolumeIDStart>8</VolumeIDStart><VolumeIDEnd>8</VolumeIDEnd><IssueIDStart>2</IssueIDStart><IssueIDEnd>2</IssueIDEnd></ArticleContext></ArticleInfo><ArticleHeader><AuthorGroup><Author AffiliationIDS="Aff1"><AuthorName DisplayOrder="Western"><GivenName>E.</GivenName><GivenName>M.</GivenName><FamilyName>Lemmel</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff2"><AuthorName DisplayOrder="Western"><GivenName>D.</GivenName><FamilyName>Brackertz</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff1"><AuthorName DisplayOrder="Western"><GivenName>M.</GivenName><FamilyName>Franke</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff3"><AuthorName DisplayOrder="Western"><GivenName>W.</GivenName><FamilyName>Gaus</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff4"><AuthorName DisplayOrder="Western"><GivenName>P.</GivenName><GivenName>W.</GivenName><FamilyName>Hartl</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff5"><AuthorName DisplayOrder="Western"><GivenName>K.</GivenName><FamilyName>Machalke</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff6"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName><FamilyName>Mielke</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff7" CorrespondingAffiliationID="Aff7"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName><GivenName>J.</GivenName><FamilyName>Obert</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff8"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName><GivenName>H.</GivenName><FamilyName>Peter</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff9"><AuthorName DisplayOrder="Western"><GivenName>J.</GivenName><FamilyName>Sieper</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff10"><AuthorName DisplayOrder="Western"><GivenName>R.</GivenName><FamilyName>Sprekeler</FamilyName></AuthorName></Author><Author AffiliationIDS="Aff11"><AuthorName DisplayOrder="Western"><GivenName>H.</GivenName><FamilyName>Stierle</FamilyName></AuthorName></Author><Affiliation ID="Aff1"><OrgName>Staatliches Rheumakrankenhaus</OrgName><OrgAddress><City>Baden-Baden</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff2"><OrgName>St. Vincenz- und Elisabeth-Hospital</OrgName><OrgAddress><City>Mainz</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff3"><OrgName>Universität Ulm, Klinische Dokumentation</OrgName><OrgAddress><City>Ulm</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff4"><OrgName>Rheumaklinik und Rheumaforschungsinstitut</OrgName><OrgAddress><City>Aachen</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff5"><OrgName>Kurklinik Lippe</OrgName><OrgAddress><City>Horn-Bad Meinberg</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff6"><OrgName>Medizinische Hochschule</OrgName><OrgAddress><City>Hannover</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff7"><OrgName>Bioferon biochemische Substanzen GmbH & Co.</OrgName><OrgAddress><Postbox>Postfach 302</Postbox><Postcode>D-7958</Postcode><City>Laupheim</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff8"><OrgName>Medizinische Universitätsklinik, Abt. Rheumatologie</OrgName><OrgAddress><City>Freiburg</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff9"><OrgName>Universitätsklinikum Steglitz</OrgName><OrgAddress><City>Berlin</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff10"><OrgName>Staatliches Rheumakrankenhaus</OrgName><OrgAddress><City>Wildbad</City><Country>Germany</Country></OrgAddress></Affiliation><Affiliation ID="Aff11"><OrgName>Brüderkrankenhaus</OrgName><OrgAddress><Street>2. Medizinische Abteilung</Street><City>Trier</City><Country>Germany</Country></OrgAddress></Affiliation></AuthorGroup><Abstract ID="Abs1" Language="En"><Heading>Summary</Heading><Para>In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 μg daily for 20 days, then 50 μg each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie “joint pain index” or Lansbury “joint pain index” by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of <Emphasis Type="Italic">a</Emphasis><1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3°C on average, but was below 37.2°C at all times.</Para></Abstract><KeywordGroup Language="En"><Heading>Key words</Heading><Keyword>Rheumatoid arthritis</Keyword><Keyword>Interferon-gamma</Keyword><Keyword>Double-blind placebo-controlled trial</Keyword></KeywordGroup></ArticleHeader><NoBody></NoBody></Article></Issue></Volume></Journal></Publisher></istex:document></istex:metadataXml><mods version="3.6"><titleInfo lang="en"><title>Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma</title></titleInfo><titleInfo type="alternative" contentType="CDATA" lang="en"><title>Results of a multicenter placebo-controlled double-blind randomized phase III clinical study of treatment of rheumatoid arthritis with recombinant interferon-gamma</title></titleInfo><name type="personal"><namePart type="given">E.</namePart><namePart type="given">M.</namePart><namePart type="family">Lemmel</namePart><affiliation>Staatliches Rheumakrankenhaus, Baden-Baden, 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, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">M.</namePart><namePart type="family">Franke</namePart><affiliation>Staatliches Rheumakrankenhaus, Baden-Baden, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">W.</namePart><namePart type="family">Gaus</namePart><affiliation>Universität Ulm, Klinische Dokumentation, Ulm, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">P.</namePart><namePart type="given">W.</namePart><namePart type="family">Hartl</namePart><affiliation>Rheumaklinik und Rheumaforschungsinstitut, Aachen, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">K.</namePart><namePart type="family">Machalke</namePart><affiliation>Kurklinik Lippe, Horn-Bad Meinberg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Mielke</namePart><affiliation>Medizinische Hochschule, Hannover, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal" displayLabel="corresp"><namePart type="given">H.</namePart><namePart type="given">J.</namePart><namePart type="family">Obert</namePart><affiliation>Bioferon biochemische Substanzen GmbH & Co., Postfach 302, D-7958, Laupheim, Germany</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>Medizinische Universitätsklinik, Abt. Rheumatologie, Freiburg, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">J.</namePart><namePart type="family">Sieper</namePart><affiliation>Universitätsklinikum Steglitz, Berlin, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">R.</namePart><namePart type="family">Sprekeler</namePart><affiliation>Staatliches Rheumakrankenhaus, Wildbad, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><name type="personal"><namePart type="given">H.</namePart><namePart type="family">Stierle</namePart><affiliation>Brüderkrankenhaus, 2. Medizinische Abteilung, Trier, Germany</affiliation><role><roleTerm type="text">author</roleTerm></role></name><typeOfResource>text</typeOfResource><genre type="research-article" displayLabel="OriginalPaper"></genre><originInfo><publisher>Springer-Verlag</publisher><place><placeTerm type="text">Berlin/Heidelberg</placeTerm></place><dateCreated encoding="w3cdtf">1987-12-09</dateCreated><dateIssued encoding="w3cdtf">1988-04-01</dateIssued><copyrightDate encoding="w3cdtf">1988</copyrightDate></originInfo><language><languageTerm type="code" authority="rfc3066">en</languageTerm><languageTerm type="code" authority="iso639-2b">eng</languageTerm></language><physicalDescription><internetMediaType>text/html</internetMediaType></physicalDescription><abstract lang="en">Summary: In a multicenter placebo-controlled double-blind randomized clinical study, 91 patients with rheumatoid arthritis were given 28 days' treatment with recombinant interferon-gamma (50 μg daily for 20 days, then 50 μg each second day up to day 28, given by subcutaneous injection). The aim of the study was to provide a methodologically clear demonstration of the efficacy of treatment with interferon-gamma, using criteria that could be handled by statistical tests. Evaluatable documentation was available for 79 patients, of whom 40 were treated with the active compound. The principal criterion for the statistical evaluation of the therapeutic success was improvement of the Ritchie “joint pain index” or Lansbury “joint pain index” by at least 30% within 28 days. The chi-square test showed superiority of the interferon arm over the placebo arm with an error probability of a<1%. In addition, efficacy of interferon-gamma was demonstrated in respect of practically all parameters investigated. The frequency of side-effects, including febrile reactions, was the same for the active compound and the placebo. During interferon treatment the daily maximum body temperature was raised by 0.3°C on average, but was below 37.2°C at all times.</abstract><note>Originals</note><relatedItem type="host"><titleInfo><title>Rheumatology International</title><subTitle>Clinical and Experimental Investigations</subTitle></titleInfo><titleInfo type="abbreviated"><title>Rheumatol Int</title></titleInfo><genre type="journal" displayLabel="Archive Journal"></genre><originInfo><dateIssued encoding="w3cdtf">1988-04-01</dateIssued><copyrightDate encoding="w3cdtf">1988</copyrightDate></originInfo><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">7</identifier><identifier type="VolumeIssueCount">6</identifier><part><date>1988</date><detail type="volume"><number>8</number><caption>vol.</caption></detail><detail type="issue"><number>2</number><caption>no.</caption></detail><extent unit="pages"><start>87</start><end>93</end></extent></part><recordInfo><recordOrigin>Springer-Verlag, 1988</recordOrigin></recordInfo></relatedItem><identifier type="istex">1ADC94078E14EE49BBF3C2632BFBB82DE262C811</identifier><identifier type="DOI">10.1007/BF00271840</identifier><identifier type="ArticleID">BF00271840</identifier><identifier type="ArticleID">Art7</identifier><accessCondition type="use and reproduction" contentType="copyright">Springer-Verlag, 1988</accessCondition><recordInfo><recordContentSource>SPRINGER</recordContentSource><recordOrigin>Springer-Verlag, 1988</recordOrigin></recordInfo></mods></metadata><serie></serie></istex></record>Pour manipuler ce document sous Unix (Dilib)
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