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

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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 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.

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Author information

Authors and Affiliations

  1. Max-Planck-Institut für Biochemie, Martinsried

    P. H. Hofschneider & U. Winter

  2. Staatliches Rheumakrankenhaus Baden-Baden, Baden Baden, Germany

    E. -M. Lemmel & B. Brölz (main investigator)

  3. Universität Ulm, Ulm, Germany

    W. Gaus & S. Schmid

  4. Bioferon biochemische Substanzen GmbH & Co., Laupheim

    H. -J. Obert & C. Stetter

  5. Medizinische Universitätsklinik, Luitpoldkrankenhaus, Würzburg

    I. O. Auer & C. Papst

  6. Medizinische Abteilung, Krankenhaus der Barmherzigen Brüder Trier, Trier, Germany

    W. H. Boesken & H. E. Stierle II

  7. Rheumatologische Abteilung, Rotes Kreuz-Krankenhaus Bremen, Bremen, Germany

    U. Botzenhardt & W. Reemtsen

  8. St. Vincenz- und Elisabeth-Hospital Mainz, Mainz, Germany

    D. Brackertz & D. Richter

  9. Medizinische Universitätsklinik Köln, Koln, Germany

    V. Diehl & A. K. von Kalle

  10. Krankenhaus Porz/Rhein, Abteilung Rheumatologie, Köln

    C. Gärtner & S. Herzig

  11. Medizinische Poliklinik V Heidelberg, Heidelberg, Germany

    J. Goronzy & C. Weyand

  12. Medizinische Klinik III und Institut für klinische Immunologie und Rheumatologie Erlangen, Erlangen, Germany

    J. R. Kalden & F. Strobel

  13. Klinik Lippe, Horn-Bad Meinberg

    K. Machalke

  14. Abteilung Rheumatologie und klinische Immunologie, Medizinische Universitätsklinik Freiburg, Freiburg, Germany

    H. H. Peter & S. Meske

  15. Rheumaeinheit, Medizinische Poliklinik der Universität München, Munchen, Germany

    M. Schattenkirchner & K. Krüger

  16. Diakoniekrankenhaus Rotenburg/Wümme, Rotenburg/Wümme, Germany

    R. Sprekeler

  17. Abteilung Innere Medizin II, Medizinische Klinik Tübingen, Tubingen, Germany

    H. D. Waller & J. G. Saal

  18. Katholisches Krankenhaus Essen-Werden, Essen, Germany

    H. Warnatz & G. Lemm

  19. Medizinische Poliklinik der Universität Würzburg, Wurzburg, Germany

    K. Wilms & T. Stolzenburg

Authors
  1. P. H. Hofschneider
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  2. U. Winter
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  3. E. -M. Lemmel
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  4. B. Brölz
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  5. W. Gaus
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  6. S. Schmid
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  7. H. -J. Obert
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  8. C. Stetter
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  9. I. O. Auer
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  10. C. Papst
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  11. W. H. Boesken
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  12. H. E. Stierle II
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  13. U. Botzenhardt
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  14. W. Reemtsen
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  15. D. Brackertz
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  16. D. Richter
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  17. V. Diehl
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  18. A. K. von Kalle
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  19. C. Gärtner
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  20. S. Herzig
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  21. J. Goronzy
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  22. C. Weyand
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  23. J. R. Kalden
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  24. F. Strobel
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  25. K. Machalke
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  26. H. H. Peter
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  27. S. Meske
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  28. M. Schattenkirchner
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  29. K. Krüger
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  30. R. Sprekeler
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  31. H. D. Waller
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  32. J. G. Saal
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  33. H. Warnatz
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  34. G. Lemm
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  35. K. Wilms
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  36. T. Stolzenburg
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German Lymphokine Study Group

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German Lymphokine Study Group., Hofschneider, P.H., Winter, U. et al. Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis. Rheumatol Int 12, 175–185 (1992). https://doi.org/10.1007/BF00302149

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  • DOI: https://doi.org/10.1007/BF00302149

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