Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Moderately to Severely Active Psoriatic Arthritis

Conditions

• Arthritis
• Psoriatic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• adalimumab — DRUG
  40 mg eow Week 0 - Week 24
• placebo for adalimumab — DRUG
  40 mg eow Week 0 - Week 24

Study Details

Multicenter Study of the Safety and Efficacy of the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis

Key Dates

Start date

Mar 31, 2003

Status verified

Mar 2008

Primary completion

Apr 30, 2004

Study Design

Enrollment

315 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: A
• Placebo Comparator: B

Primary Outcome Measure

ACR20 [ Time Frame: Week 12 ]

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