Results of a phase-II clinical trial on treatment of rheumatoid arthritis with recombinant interferon-gamma

In an open, non-randomized clinical trial conducted at multiple centres, 49 patients with rheumatoid arthritis were treated with recombinant interferon-gamma for 20 days. The study was carried out in two sub-studies. In the first, the total daily dose of interferon-gamma was 50 micrograms; in the se...

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Bibliographic Details
Published in:Rheumatology international 1987-01, Vol.7 (3), p.127-132
Main Authors: Lemmel, E M, Franke, M, Gaus, W, Hartl, P W, Hofschneider, P H, Miehlke, K, Machalke, K, Obert, H J
Format: Article
Language:English
Subjects:
Adult
Aged
Anti-Inflammatory Agents - administration & dosage
Anti-Inflammatory Agents - therapeutic use
Arthritis, Rheumatoid - physiopathology
Arthritis, Rheumatoid - therapy
Drug Evaluation
Drug Therapy, Combination
Female
Humans
Interferon-gamma - administration & dosage
Interferon-gamma - adverse effects
Interferon-gamma - therapeutic use
Male
Middle Aged
Pain Management
Recombinant Proteins
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Summary:In an open, non-randomized clinical trial conducted at multiple centres, 49 patients with rheumatoid arthritis were treated with recombinant interferon-gamma for 20 days. The study was carried out in two sub-studies. In the first, the total daily dose of interferon-gamma was 50 micrograms; in the second, 100 micrograms. Of the 49 cases, 40 were evaluable for statistical analysis; 24 of these patients (60%) responded to therapy, according to the criteria of a successful outcome laid down in the study protocol, and were classified as responders. In responders, the clinical parameters investigated improved with both dosages. The lower dosage differed from the higher one in having a markedly lower incidence of side-effects. The results lead to the conclusion that a randomized double-blind phase-III clinical trial should be performed.
ISSN:0172-8172
1437-160X
DOI:10.1007/BF00270465