Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis

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, U. Botzenhardt, W. Reemtsen, D. Brackertz, D. Richter, V. Diehl, A. K. von Kalle, C. Gärtner, S. HerzigJ. 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. Stolzenburg

Research output: Contribution to journalArticlepeer-review

29 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)175-185
Number of pages11
JournalRheumatology International
Volume12
Issue number5
DOIs
StatePublished - Nov 1992

Keywords

  • Controlled clinical trial
  • Interferon gamma
  • Multicenter
  • Rheumatoid arthritis

ASJC Scopus subject areas

  • Immunology and Allergy
  • Rheumatology
  • Immunology

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