Prospective Study on Intensive Early Rheumatoid Arthritis Treatment (CURE)
Rheumatoid Arthritis
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, clinical remission
Eligibility Criteria
Inclusion Criteria:
- Active rheumatoid arthritis diagnosed for at least 6 weeks, but no more than 1 year, according to the revised 1987 ACR criteria
- Naïve to treatment with MTX
- Swollen joint count (SJC) > 8 tender joint count (TJC) > 8
- At screening CRP > 1.5 mg/dL (15 mg/L) or ESR ≥ 28 mm/h
- ≥ 1 joint erosion or RF positivity or anti-CCP positivity
- Age 18-70 years.
Exclusion Criteria:
- Rheumatic autoimmune disease other than RA
- Functional class IV
- Any surgical procedure within 12 weeks prior to baseline or planned during the study.
- Pregnancy or breast feeding.
- Evidence of significant concomitant disease
- Primary or secondary immunodeficiency
- active infection of any kind
- History of previously untreated infection with mycobacterium tuberculosis or current treatment for same.
- History of cancer
- Any history or presence of congestive heart failure (CHF) (New York Heart Association classification for CHF: Class III or IV).
- Any history of myocardial infarction within 5 years.
- History of a severe allergic or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of adalimumab or methotrexate.
- Positive serology for hepatitis B or C indicating active infection.
- Hemoglobin < 8.0 g/dL.
- Absolute neutrophil count (ANC) < 1.5 x 103/L.
- Liver function abnormality
Sites / Locations
- IRCCS S. Matteo Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
group A
group B
adalimumab 40 mg subcutaneous injections every other week from baseline to month 12 methotrexate orally weekly at initial dose of 10 mg rising to 20 mg weekly over 4 weeks in 2.5 mg increments, continued up to month 24. prednisone orally 50 mg daily, gradually tapered up to 6.25 mg at week 7 and stopped at month 6
adalimumab 40 mg subcutaneous injections every other week from baseline to the end of month 12 methotrexate orally oweekly at an initial dose of 10 mg rising to 20 mg weekly over 4 weeks in 2.5 mg increments, continued up to month 24. placebo orally, stopped at month 6