Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Study ID
NCT00480272
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • adalimumab, plus prednisone — DRUG
    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
  • adalimumab plus placebo — DRUG
    adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months

Study Details

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

Key Dates

Start date
May 31, 2007
Status verified
Mar 2017
Primary completion
Mar 1, 2017
Completion
Mar 1, 2017

Study Design

Enrollment
251 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: group A
    * 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
  • Placebo Comparator: group B
    * 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 Measure

to evaluate the proportion of subjects who achieve remission at week 52 after treatment, as defined by DAS 28 </= 2.6 [ Time Frame: 52 weeks ]

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