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

• DOI: 10.1007/bf00302149
• Publication Date: 2004-10-09T23:53:12Z
• Authors: 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. 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. Stolzenburg
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

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 fur Biochemie, Munchen. 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.