Rheumatoid Arthritis
Conditions
Keywords
rheumatoid arthritis, clinical remission
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.
Interventions
DRUGadalimumab, plus prednisone
adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo or prednisone 50 mg/po day then reduced to 6.25/po day
DRUGadalimumab plus placebo
adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months
Sponsors
Fondazione IRCCS Policlinico San Matteo di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28 </= 2.6 | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Italy
Outcome results
None listed