Conditions: Rheumatoid Arthritis
Keywords: CoBRA
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 400
Healthy volunteers: no

Brief summary:
The Combinatietherapie Bij Reumatoide Artritis (CoBRA) trial was a milestone in the development of the present treatment paradigm for Rheumatoid Arthritis (RA). This study introduced the principle of fast remission induction by means of a combination of standard Disease Modifying AntiRheumatic Drugs (DMARDs) and a step down bridge therapy with high dose glucocorticoids in early Rheumatoid Arthritis.

The purpose of the present study is to compare different combinations of traditional DMARDs and glucocorticoids, based on the original CoBRA protocol, for treatment of early Rheumatoid Arthritis.

Besides the efficacy and effectiveness of these strategies, patient centered outcomes and potential implementation problems of such treatment strategies are evaluated.

Detailed description:

Arms:
arm 1: * Methotrexate 15mg tablet by mouth, weekly for entire trial
* Sulfasalazine 2g tablet by mouth, daily for 40 weeks
* Prednisone tablet by mouth, weekly step down scheme 60 - 40 - 25 - 20 - 15 - 10 mg daily for 6 weeks, followed by 7.5mg daily till week 28, then further tapered down to stop at week 32 arm 2: * Methotrexate 15mg tablet by mouth, weekly for entire trial
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32 arm 3: * Methotrexate 15mg tablet by mouth, weekly for 40 weeks (continued for entire trial if randomized to Methotrexate monotherapy at week 40)
* Leflunomide 10mg tablet by mouth, daily for 40 weeks (continued for entire trial if randomized to Leflunomide monotherapy at week 40)
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32 arm 4: * Methotrexate 15mg tablet by mouth, weekly for entire trial
* Prednisone tablet by mouth, weekly step down scheme 30 - 20 - 12.5 - 10 - 7.5 mg daily for 5 weeks, followed by 5mg daily till week 28, then further tapered down to stop at week 32 arm 5: * Methotrexate 15mg tablet by mouth, weekly for entire trial
* No oral steroids allowed during the first year of the trial

Interventions: intervention 1: Methotrexate intervention 2: Sulfasalazine intervention 3: Leflunomide intervention 4: Prednisone
Intervention descriptions: intervention 1: Methotrexate tablet intervention 2: Sulfasalazine tablet intervention 3: Leflunomide tablet intervention 4: Prednisone tablet

Protocol document: