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

Abbott

Status and phase: Completed; Phase 2

Conditions: Arthritis; Psoriatic

Treatments: Drug: adalimumab; Drug: placebo for adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646386

M02-518

Details and patient eligibility

About

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

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe PsA
• Inadequate response to DMARD therapy
• Corticosteroid stable dose <= 10 mg QD
• DMARDs must have been taken for 3 months and stable dose for 4 weeks
• MTX maximum dose = <= 30 mg/week
• Active chronic plaque PS or documented history of chronic plaque PS

Exclusion criteria

• No other active skin disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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315 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: adalimumab

B

Placebo Comparator group

Treatment:

Drug: placebo for adalimumab