Back to resultsStudy 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
Primary Purpose
Arthritis, Psoriatic
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
adalimumab
placebo for adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
ACR20
Adverse Events
Secondary Outcome Measures
ACR50/70
Modified Psoriatic Arthritis Response Criteria
Multiple QOL Assessments
Physicians Global Assessment for Psoriasis
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00646178
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
March 2004 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Psoriatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
adalimumab
Other Intervention Name(s)
ABT-D2E7, Humira
Intervention Description
40 mg adalimumab eow Week 0 - Week 12
Intervention Type
Drug
Intervention Name(s)
placebo for adalimumab
Other Intervention Name(s)
placebo
Intervention Description
placebo eow Week 0 - Week 12
Primary Outcome Measure Information:
Title
ACR20
Time Frame
Week 12
Title
Adverse Events
Time Frame
Throughout the Study
Secondary Outcome Measure Information:
Title
ACR50/70
Time Frame
Week 12
Title
Modified Psoriatic Arthritis Response Criteria
Time Frame
Week 12
Title
Multiple QOL Assessments
Time Frame
Week 12
Title
Physicians Global Assessment for Psoriasis
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Learn more about this trial
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
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