Human Anti-tumor Necrosis Factor (TNF) Monoclonal Antibody Adalimumab in Subjects With Active Ankylosing Spondylitis

Conditions

• Ankylosing Spondylitis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• adalimumab (D2E7) — BIOLOGICAL
  Adalimumab 40 mg every other week, subcutaneous
• placebo — BIOLOGICAL
  Placebo every other week, subcutaneous

Study Details

The objective of this study was to evaluate the safety and efficacy of adalimumab 40 mg given every other week (eow) in subjects with active ankylosing spondylitis (AS) who have had an inadequate response to, or who are intolerant to, treatment with at least 1 nonsteroidal anti-inflammatory drug (NSAID) and who may have also failed treatment with at least 1 disease-modifying antirheumatic drug (DMARD).

Key Dates

Start date

Jan 31, 2004

Status verified

Apr 2011

Primary completion

Dec 31, 2004

Completion

Jul 31, 2009

Study Design

Enrollment

315 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Adalimumab
• Placebo Comparator: Placebo

Primary Outcome Measure

Number of Responders With a Reduction of Signs and Symptoms of Ankylosing Spondylitis (AS) as Measured With ASAS International Working Group Response Criteria (ASAS 20). [ Time Frame: Week 12 ]

Locations (22)

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