Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severely Active Psoriatic Arthritis Subjects With Inadequate Response to Disease Modifying Anti-Rheumatic Drug Therapy

Abbott

Status and phase: Completed; Phase 3

Conditions: Arthritis; Psoriatic

Treatments: Drug: adalimumab; Drug: placebo for adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00646178

M02-570

Details and patient eligibility

About

Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects with Moderate to Severely Active Psoriatic Arthritis Subjects with Inadequate Response to Disease Modifying anti-Rheumatic Drug Therapy

Enrollment: 102 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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102 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