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. 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

doi:10.1007/BF00302149

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

Immunology

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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 language	English (US)
Pages (from-to)	175-185
Number of pages	11
Journal	Rheumatology International
Volume	12
Issue number	5
DOIs	https://doi.org/10.1007/BF00302149
State	Published - Nov 1992

Keywords

Controlled clinical trial
Interferon gamma
Multicenter
Rheumatoid arthritis

ASJC Scopus subject areas

Immunology and Allergy
Rheumatology
Immunology

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10.1007/BF00302149

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Hofschneider, P. H., Winter, U., Lemmel, E. M., Brölz, B., Gaus, W., Schmid, S., Obert, H. J., Stetter, C., Auer, I. O., Papst, C., Boesken, W. H., Stierle, H. E., Botzenhardt, U., Reemtsen, W., Brackertz, D., Richter, D., Diehl, V., von Kalle, A. K., Gärtner, C., ... Stolzenburg, T. (1992). Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis. Rheumatology International, 12(5), 175-185. https://doi.org/10.1007/BF00302149

Hofschneider, PH, Winter, U, Lemmel, EM, Brölz, B, Gaus, W, Schmid, S, Obert, HJ, Stetter, C, Auer, IO, Papst, C, Boesken, WH, Stierle, HE, Botzenhardt, U, Reemtsen, W, Brackertz, D, Richter, D, Diehl, V, von Kalle, AK, Gärtner, C, Herzig, S, Goronzy, J, Weyand, C, Kalden, JR, Strobel, F, Machalke, K, Peter, HH, Meske, S, Schattenkirchner, M, Krüger, K, Sprekeler, R, Waller, HD, Saal, JG, Warnatz, H, Lemm, G, Wilms, K & Stolzenburg, T 1992, 'Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis', Rheumatology International, vol. 12, no. 5, pp. 175-185. https://doi.org/10.1007/BF00302149

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title = "Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis",

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 f{\"u}r Biochemie, M{\"u}nchen. 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.",

keywords = "Controlled clinical trial, Interferon gamma, Multicenter, Rheumatoid arthritis",

author = "Hofschneider, {P. H.} and U. Winter and Lemmel, {E. M.} and B. Br{\"o}lz and W. Gaus and S. Schmid and Obert, {H. J.} and C. Stetter and Auer, {I. O.} and C. Papst and Boesken, {W. H.} and Stierle, {H. E.} and U. Botzenhardt and W. Reemtsen and D. Brackertz and D. Richter and V. Diehl and {von Kalle}, {A. K.} and C. G{\"a}rtner and S. Herzig and J. Goronzy and C. Weyand and Kalden, {J. R.} and F. Strobel and K. Machalke and Peter, {H. H.} and S. Meske and M. Schattenkirchner and K. Kr{\"u}ger and R. Sprekeler and Waller, {H. D.} and Saal, {J. G.} and H. Warnatz and G. Lemm and K. Wilms and T. Stolzenburg",

year = "1992",

month = nov,

doi = "10.1007/BF00302149",

language = "English (US)",

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T1 - Double blind controlled phase III multicenter clinical trial with interferon gamma in rheumatoid arthritis

AU - Hofschneider, P. H.

AU - Winter, U.

AU - Lemmel, E. M.

AU - Brölz, B.

AU - Gaus, W.

AU - Schmid, S.

AU - Obert, H. J.

AU - Stetter, C.

AU - Auer, I. O.

AU - Papst, C.

AU - Boesken, W. H.

AU - Stierle, H. E.

AU - Botzenhardt, U.

AU - Reemtsen, W.

AU - Brackertz, D.

AU - Richter, D.

AU - Diehl, V.

AU - von Kalle, A. K.

AU - Gärtner, C.

AU - Herzig, S.

AU - Goronzy, J.

AU - Weyand, C.

AU - Kalden, J. R.

AU - Strobel, F.

AU - Machalke, K.

AU - Peter, H. H.

AU - Meske, S.

AU - Schattenkirchner, M.

AU - Krüger, K.

AU - Sprekeler, R.

AU - Waller, H. D.

AU - Saal, J. G.

AU - Warnatz, H.

AU - Lemm, G.

AU - Wilms, K.

AU - Stolzenburg, T.

PY - 1992/11

Y1 - 1992/11

N2 - 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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KW - Controlled clinical trial

KW - Interferon gamma

KW - Multicenter

KW - Rheumatoid arthritis

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JO - Rheumatology International

JF - Rheumatology International

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ER -

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

Abstract

Keywords

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