Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: P. Verschueren
• Collaborator: Agentschap voor Innovatie door Wetenschap en Technologie
• Treatments: Leflunomide; Methotrexate; Prednisone; Sulfasalazine

Criteria

Inclusion Criteria:

• Diagnosis of RA as defined by the 1987 or 2010 revised American College of Rheumatology (ACR) criteria

• Early RA (less than 1 year)

• Use a reliable method of contraception for women of childbearing potential

• Able and willing to give written informed consent and participate in the study

Exclusion Criteria:

• Previous treatment with DMARDs

• Previous treatment with oral corticosteroids at a dosage of more than 10 milligrams (mg) prednisone within 4 weeks before baseline

• Previous treatment with oral corticosteroids at a dosage equal to or less than 10 mg prednisone within 2 weeks before baseline

• Previous treatment with oral corticosteroids for more than 4 weeks

• Previous treatment with Intra Articular corticosteroids within 4 weeks before baseline

• Previous treatment with an investigational drug for the treatment or prevention of RA

• Contraindications for corticosteroids

• Contraindications for DMARDs

• Psoriatic Arthritis

• Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency which in the opinion of the investigator places the patient at an unacceptable risk for participation in the study

• Pregnancy, breastfeeding or no use of a reliable method of contraception

• Alcohol or drug abuse