Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

Launched by FONDAZIONE IRCCS POLICLINICO SAN MATTEO DI PAVIA · May 29, 2007

Keywords

ClinConnect Summary

Treatment group A 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + prednisone 50 mg/d tapered to 6.25 mg 6 - 12 months: Adalimumab 40 mg eow plus methotrexate 20 mg weekly group B 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + placebo 6 - 12 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly

Follow up period - Open Label phase:

Patients achieving clinical remission will be than treated only with MTX and observed for another 12 months period. Patients who do not achieve clinical remission or...

Gender

ALL

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