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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00646386
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 the Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Moderately to Severely Active Psoriatic Arthritis


Condition Intervention Phase
Arthritis
Psoriatic
 Drug: adalimumab
Drug: placebo for adalimumab
 Phase 2

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 Moderately to Severely Active Psoriatic Arthritis

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 study participation ] [ Designated as safety issue: Yes ]
  • Sharp Score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ACR20, 50, 70 [ Time Frame: Weeks 12, 24 ] [ Designated as safety issue: No ]
  • Modified Psoriatic Arthritis Response Criteria, HAQ, SF-36, Physician's Global Assessment, PASI, DLQI [ Time Frame: Weeks 12 and 24 ] [ Designated as safety issue: No ]

Enrollment: 315
Study Start Date: March 2003
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A Drug: adalimumab
40 mg eow Week 0 - Week 24
Other Names:
  • ABT-D2E7
  • Humira
  • adalimumab
Placebo Comparator: B Drug: placebo for adalimumab
40 mg eow Week 0 - Week 24
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Beverly Paperiello/Director, Clinical Development Operations, Abbott
ClinicalTrials.gov Identifier: NCT00646386     History of Changes
Other Study ID Numbers: M02-518
Study First Received: March 26, 2008
Last Updated: March 26, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
 Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Adalimumab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013