Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Methotrexate; Sulfasalazine; Leflunomide; Prednisone
Intervention description: Methotrexate tablet; Sulfasalazine tablet; Leflunomide tablet; Prednisone tablet
Intervention MeSH terms: Sulfasalazine; Prednisone; Methotrexate; Leflunomide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Before randomisation patients were stratified to a high-risk or low-risk group according to the presence of risk factors at screening (having erosions, rheumatoid factor and/or anticitrullinated protein antibody and a high disease activity score calculated with C-reactive protein (DAS28-CRP)). Randomisation to treatment arms was performed via a digitally generated sequence. Patients in the high-risk group were randomised into CoBRA Classic, Clim or Avant-Garde arm. Patients in the low-risk group were randomised into CoBRA Slim or Tight Step Up arm.
Masking: None (Open Label)
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CoBRA

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.
    

Eligibility 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