Prospective Study on Intensive Early Rheumatoid Arthritis Treatment
- Conditions
- Rheumatoid Arthritis
- Interventions
- Registration Number
- NCT00480272
- Lead Sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Brief 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
- Detailed Description
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 patients who will experience a relapse of the disease will be treated according to standard of care (SOC) modalities.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group A adalimumab, plus prednisone * 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 group B adalimumab plus placebo * 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
- Primary Outcome Measures
Name Time Method to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28 </= 2.6 52 weeks
- Secondary Outcome Measures
Name Time Method subjects who maintain stable remission at 24 months; ACR 20,50,70 at month 4,8,12,24; DAS 28 at month 4,8,12,24; HAQ at week 0,4,8,12,24; radiographic progression at months 12, 24; safety of different treatment regimens 24 months
Trial Locations
- Locations (1)
IRCCS S. Matteo Hospital
🇮🇹Pavia, Italy