Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

• Status: Completed
• Trial end date: 2017-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Hypothesis: Early intensive treatment with anti-TNF agent plus methotrexate plus high dose prednisone may increase remission rate and may induce stable remission in Rheumatoid Arthritis Objective: to evaluate induction of remission using adalimumab, prednisone and methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone

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

Details

• Lead Sponsor: IRCCS Policlinico S. Matteo
• Treatments: Adalimumab; Prednisone

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