Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA)

Sponsor
University of Aarhus
Study ID
NCT00660647
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Adalimumab injection 0.8 ml (40 mg) s.c. every second week in up to 2 years
  • Placebo — DRUG
    Saline injection 0.9%, 0.8 ml s.c. every second week up to 2 years

Study Details

Optimized treatment algorithm in early rheumatoid arthritis: Methotrexate and intra-articular glucocorticosteroid plus adalimumab or placebo in the treatment of early rheumatoid arthritis. A Randomised, double-blind and placebo-controlled, two arms, parallel group study of the additive effect of adalimumab concerning inflammatory control and inhibition of erosive development. Optimized Treatment Algorithms for Patients with Early RA

Key Dates

Start date
Sep 30, 2007
Status verified
Nov 2015
Primary completion
Dec 31, 2011
Completion
Dec 31, 2011

Study Design

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

Arms

  • Experimental: methotrexate + adalimumab
    Methotrexate and intraarticular triamcinolone hexacetonide plus adalimumab.
  • Placebo Comparator: methotrexate + placebo
    Methotrexate and intraarticular triamcinolone hexacetonide and placebo

Primary Outcome Measure

Number of patients who achieve a DAS28 < 3.2 [ Time Frame: 0, 1, 3, 6, 9, 12 and 24 months (DAS28) ]

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