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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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00646178
First received: March 26, 2008
Last updated: NA
Last verified: March 2008
History: No changes posted
  Purpose

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


Condition Intervention Phase
Arthritis
Psoriatic
 Drug: adalimumab
Drug: placebo for adalimumab
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • ACR20 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Throughout the Study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • ACR50/70 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Modified Psoriatic Arthritis Response Criteria [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Multiple QOL Assessments [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Physicians Global Assessment for Psoriasis [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Enrollment: 102
Study Start Date: June 2003
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: adalimumab
40 mg adalimumab eow Week 0 - Week 12
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Placebo Comparator: B Drug: placebo for adalimumab
placebo eow Week 0 - Week 12
Other Name: placebo

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Beverly Paperiello / Director, Clinical Research Development, Abbott
ClinicalTrials.gov Identifier: NCT00646178     History of Changes
Other Study ID Numbers: M02-570
Study First Received: March 26, 2008
Last Updated: March 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Joint Diseases
Musculoskeletal Diseases
Adalimumab
 Antirheumatic Agents
Anti-Inflammatory Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015