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© 1987 British Society for Rheumatology

research-article

INTRA-ARTICULAR RIMEXOLONE IN THE RHEUMATOID KNEE: A PLACEBO-CONTROLLED, DOUBLE-BLIND, MULTICENTRE TRIAL OF THREE DOSES

E. van VLIET-DASKALOPOULOU, T. JENTJENS, R. T. C. SCHEFFER and THE INTERNATIONAL RIMEXOLONE (Org 6216) STUDY GROUP*

Scientific Development Group, Organon International B.V. P.O. Box 20, 5340 BH Oss, The Netherlands

Correspondence to: Address correspondence to Dr. van Vlict-Daskalopoulou.

One-hundred and thirty-seven patients with classical or definite rheumatoid arthritis, involving at least one knee joint, were randomly allocated to a single intra-articular injection of 10, 20 or 40 mg of rimexolone (Org 6216) or placebo. The follow-up period was 84 days, during which clinical and laboratory assessments were done. Clinical improvement of the treated knee joint was measured by the following variables: pain, tenderness, morning stiffness, swelling, range of movement and walking ability.

Placebo response was considerable. However, clinical improvement with rimexolone at 20 mg and 40 mg was significantly superior to placebo for most of the variables, whilst with the 10 mg dose only reduction of tenderness was significantly superior. The duration of improvement was longest with 40 mg of rimexolone.

One single, intra-articular injection of this dose into the affected knee joint provided significant reduction in pain, tenderness and stiffness and improved the range of movement and walking ability for a period of 8 to 12 weeks.

KEY WORDS: Rheumatoid arthritis, Intra-articular injection, Single-dose, Rimexolone, Clinical trial

*Investigators. Drs O. Andrup. Diakonhjemmets Sykchus, Oslo. Norway. D. Bossingham, City Hospital. Nottingham, UK; M. Hakola, Keski-Suomi Central Hospital, Jyväskylä, Finland; B. Hazieman, Addenbrooke's Hospital, Cambridge, UK; P. Hove-S{pi}renscn, Centralsygchusct i Hillcr{pi}d, HilIcr{pi}d, Denmark, J. Hunter, Gartnavcl General Hospital, Glasgow. UK; 0 Mune, Kolding Hospital, Kolding, Denmark; 0. Mutru, Kuopio University Central Hospital, Kuopio, Finland; M. Oka, Keski-Suomi Central Hospital, Jyväskylä, Finland. A. Ruotsi, Tiuru Hospital, Tiuruniemi, Finland; M. Dc Silva. Prince Charles Hospital. Merthyr TydfIl. UK; R. Sturrock. Royal Infirmary, Glasgow, UK.


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