Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis

Sponsor
Abbott
Study ID
NCT00649922
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • adalimumab — BIOLOGICAL
    80 mg adalimumab (2 injections) day 1; 40 mg (1 injection) Day 15 and Day 29
  • placebo — BIOLOGICAL
    2 injections Day 1, 1 injection Days 15 and 29
  • adalimumab — BIOLOGICAL
    40 mg adalimumab every other week

Study Details

To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo

Key Dates

Start date
Oct 31, 2003
Status verified
Mar 2008
Primary completion
Dec 31, 2004
Completion
Feb 28, 2005

Study Design

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

Arms

  • Placebo Comparator: Double Blind
  • Experimental: Open Label

Primary Outcome Measure

Blood samples for Influenza A & B antibody Assay [ Time Frame: Baseline (Day 1), Day 36 or premature discontinuation ]

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