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Clinical Trials/NCT00646178
NCT00646178
Completed
Phase 3

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

Abbott0 sites102 target enrollmentJune 2003
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ConditionsArthritisPsoriatic
Interventionsadalimumabplacebo for adalimumab
Drugsadalimumabplacebo for adalimumab

Overview

Phase
Phase 3
Intervention
adalimumab
Conditions
Arthritis
Sponsor
Abbott
Enrollment
102
Primary Endpoint
ACR20
Status
Completed
Last Updated
18 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
June 2003
End Date
March 2004
Last Updated
18 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Abbott

Eligibility Criteria

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

Arms & Interventions

A

Intervention: adalimumab

B

Intervention: placebo for adalimumab

Outcomes

Primary Outcomes

ACR20

Time Frame: Week 12

Adverse Events

Time Frame: Throughout the Study

Secondary Outcomes

  • ACR50/70(Week 12)
  • Modified Psoriatic Arthritis Response Criteria(Week 12)
  • Multiple QOL Assessments(Week 12)
  • Physicians Global Assessment for Psoriasis(Week 12)

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