Back to resultsSafety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis
Primary Purpose
Psoriatic Arthritis
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Human anti-TNF monoclonal antibody/adalimumab
Sponsored by
About this trial
This is an interventional treatment trial for Psoriatic Arthritis
Eligibility Criteria
Inclusion Criteria: Subject completed study M02-518 or M02-570 Exclusion Criteria: Subject prematurely discontinued study M02-518 or M02-570 Female subject who is pregnant or breast-feeding or considering becoming pregnant Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Sites / Locations
- Global Medical Information-Abbott Laboratories
Outcomes
Primary Outcome Measures
Safety parameters
ACR 20/50/70
PsARC
HAQ
SF-36
FACTIT Fatigue Scale
Disease progression measurements
Secondary Outcome Measures
Patient reported outcomes
Clinical response indicators
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00195689
Brief Title
Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis
Official Title
A Multi-Center Continuation Trial for Patients Completing Study M02-518 and M02-570 of the Human Anti-TNF Monoclonal Antibody Adalimumab (D2E7) in Patients With Moderate to Severely Active Psoriatic Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2007
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the long-term safety and clinical efficacy of adalimumab in treatment of moderate to severely active psoriatic arthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriatic Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Human anti-TNF monoclonal antibody/adalimumab
Primary Outcome Measure Information:
Title
Safety parameters
Title
ACR 20/50/70
Title
PsARC
Title
HAQ
Title
SF-36
Title
FACTIT Fatigue Scale
Title
Disease progression measurements
Secondary Outcome Measure Information:
Title
Patient reported outcomes
Title
Clinical response indicators
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject completed study M02-518 or M02-570
Exclusion Criteria:
Subject prematurely discontinued study M02-518 or M02-570
Female subject who is pregnant or breast-feeding or considering becoming pregnant
Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beverly Paperiello
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Global Medical Information-Abbott Laboratories
City
Abbott Park
State/Province
Illinois
ZIP/Postal Code
60064
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20537151
Citation
Gladman DD, Mease PJ, Choy EH, Ritchlin CT, Perdok RJ, Sasso EH. Risk factors for radiographic progression in psoriatic arthritis: subanalysis of the randomized controlled trial ADEPT. Arthritis Res Ther. 2010;12(3):R113. doi: 10.1186/ar3049. Epub 2010 Jun 10.
Results Reference
derived
PubMed Identifier
18684743
Citation
Mease PJ, Ory P, Sharp JT, Ritchlin CT, Van den Bosch F, Wellborne F, Birbara C, Thomson GT, Perdok RJ, Medich J, Wong RL, Gladman DD. Adalimumab for long-term treatment of psoriatic arthritis: 2-year data from the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT). Ann Rheum Dis. 2009 May;68(5):702-9. doi: 10.1136/ard.2008.092767. Epub 2008 Aug 6.
Results Reference
derived
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Safety and Efficacy of Adalimumab in Patients With Moderate to Severely Active Psoriatic Arthritis
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