Rheumatol Int (1992) 12: 175-185 Rheumalaln I~A~AL W Clinical and Experimental Investigation8 9 Springer-Verlag 1992 Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis German Lymphokine Study Group* Received July 1, 1992/Accepted July 2, 1992 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 * Participants: Organization and documentation P. H. Hofschneider, U. Winter, Max-Planck-Institut fiir Biochemie, Martinsried E.-M. Lemmel, B. Br61z, Staatliches Rheumakrankenhaus Baden- Baden (main investigatol:) W. Gaus, S. Schmid, Universitfit Ulm (clinical documentation) H.-J. Obert, C. Stetter, Bioferon biochemische Substanzen GmbH & Co., Laupheim Hospitals and clinicians I. O. Auer, C. Papst, Medizinische UniversitS.tsklinik, Luitpold- krankenhaus Wfirzburg W. H. Boesken, H. E. Stierle, II. Medizinische Abteilung, Kranken- haus der Barmherzigen Brfider Trier U. Botzenhardt, W. Reemtsen, Rheumatologische Abteilung, Rotes Kreuz-Krankenhaus Bremen D. Brackertz, D. Richter, St. Vincenz-und Elisabeth-Hospital Mainz V. Diehl, A. K. yon Kalle, Medizinische Universit/itsklinik K61n C. G/irtner, S. Herzig, Abteilung Rheumatologie, Krankenhaus Porz/Rhein, K61n J. Goronzy, C. Weyand, Medizinische Poliklinik V Heidelberg J. R. Kalden, F. Strobel, Medizinische Klinik III und Institut ffir klinische Immunologic und Rheumatologie Erlangen E.-M. Lemmel, B. Br61z, Staatliches Rheumakrankenhaus Baden- Baden K. Machalke, Klinik Lippe, Horn-Bad Meinberg H. H. Peter, S. Meske, Abteilung Rheumatologie und klinische Immunologie, Medizinische Universit/itsklinik Freiburg M. Schattenkirchner, K. Krtiger, Rheumaeinheit, Medizinische Poliklinik der Universit/it Mfinchen R. Sprekeler, Diakoniekrankenhaus Rotenburg/Wfimme H. D. Waller, J. G. Saal, Abteilung Inhere Medizin II, Medizinische Klinik Tfibingen H. Warnatz, G. Lemm, Katholisches Krankenhaus Essen-Werden K. Wilms, T. Stolzenburg, Medizinische Poliklinik der Universit/it Wfirzburg Correspondence to: E.-M. Lemmel, Staatliches Rheumakranken- haus, Rotenbachtalstrasse 5, W-7570 Baden-Baden, Federal Re- public of Germany the president of the Max-Planck-Gesellschaft, and co- ordinated by the Max-Planck-Institut ffir Biochemie, Mfinchen. Overall, 249 patients with rheumatoid arthritis (RA) were enrolled by 16 participating hospitals. In addi- tion to NSAID treatment, patients were randomly given either interferon gamma (IFN-7) or placebo. In the IFN-7 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 in- dexes, was significantly higher in the IFN-7 group with an error probability of 1%. IFN-7 was able to reduce the quantity of corticosteroids administered. Compared with the control group, the IFN-? group benefited considering all parameters measured. Most important side effects were transient fever and transient influenza-like symp- toms; all other adverse events were comparable in both groups. Key words: Interferon gamma Rheumatoid arthritis - Controlled clinical trial - Multicenter Introduction During the last few years there has been some progress in the development and investigation of natural immuno- regulatory substances that influence rheumatic diseases. Some of these substances are under investigation and clinical testing [1]. Currently, medical treatment for rheumatic patients, especially in the active phases of the disease, is unsatisfactory. Therefore, a therapeutic princi- ple acting directly on the underlying immunologic pro- cesses is urgently required. There is general agreement that inflammation, pain, and destruction occurring in the joint during active rheumatoid arthritis (RA) are caused by a persistent in- crease in the activity of the macrophages and granulo- cytes. This activity results in the release of structure-de- stroying oxygen radicals, increased growth rate of the fibroblasts and the formation of their prostaglandin, Ez,