REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel®
This study has been completed.
Sponsor:
Amgen
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00127842
First received: August 5, 2005
Last updated: November 12, 2009
Last verified: November 2009
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Purpose
The primary objective of the study is to estimate the proportion of psoriatic arthritis (PsA) subjects achieving a greater than 0.50 unit improvement from baseline in the Healthcare Quality Assurance (HQA) disability index at month 24. Given a sample size of 125 subjects, the precision of the estimate, as reflected by the width of the 95% confidence interval, will not exceed 0.176 units.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriatic Arthritis |
Drug: Enbrel® |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rating Evaluations in Psoriatic Arthritis (PsA) With Enbrel® |
Resource links provided by NLM:
Genetics Home Reference related topics:
psoriatic arthritis
Drug Information available for:
Etanercept
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- Describe long term effectiveness of Enbrel® in subjects with PsA as measured by the Health Assessment Questionnaire Disability Index (HAQDI) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Describe long term productivity of Enbrel® in subjects with PsA in Canadian clinical practice [ Time Frame: 24 months ] [ Designated as safety issue: No ]
| Enrollment: | 110 |
| Study Start Date: | August 2005 |
| Study Completion Date: | September 2009 |
| Primary Completion Date: | August 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Enbrel
Single Arm study, all patients on Enbrel
|
Drug: Enbrel®
Single Arm, all patients on Enbrel
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria: - Presence of psoriasis or previous evidence of psoriasis documented by a dermatologist as part of usual care - At least one of the following forms of PsA:
- Distal interphalangeal (DIP) involvement (inflammatory)
- Polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
- Arthritis mutilans
- Asymmetric peripheral arthritis or
- Spinal involvement - Active psoriatic arthritis at the time of the study enrollment - Subjects must demonstrate greater than 3 swollen joints and greater than 3 tender/painful joints - Greater than 18 years of age at the time of consent - Able to start Enbrel® therapy per the approved product monograph - Informed consent must be provided before any study specific procedures are performed Exclusion Criteria: - Active infections at time of initiating Enbrel® therapy - Evidence of skin conditions (e.g., eczema) other than psoriasis that would interfere with evaluations of the study medication - A malignancy, other than basal cell carcinoma of the skin or, in situ carcinoma of the cervix, within the past 5 years - Known hypersensitivity to Enbrel® or any of its components - Subjects receiving, or who have received: * Remicade® (infliximab) in the previous 3 months or * Humira® (adalimumab) in the previous 3 months or * Kineret® (anakinra) in the previous 15 days - Subjects receiving or who have received Enbrel® - Treatment with any investigational therapy in the 30 days prior to enrollment or during the study - Active guttate, erythrodermic or pustular psoriasis at the time of screening - Presence of any significant and uncontrolled medical condition, which in the Investigator's opinion, precludes the use of Enbrel® as outlined in the product monograph - Sepsis or at risk of septic syndrome - Subjects not available for follow-up assessment - Concerns for subject's compliance with the protocol procedures
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127842
Locations
| Canada, British Columbia | |
| Research Site | |
| Vancouver, British Columbia, Canada | |
| Research Site | |
| Victoria, British Columbia, Canada | |
| Canada, Manitoba | |
| Research Site | |
| Winnipeg, Manitoba, Canada | |
| Canada, New Brunswick | |
| Research Site | |
| Fredericton, New Brunswick, Canada | |
| Canada, Newfoundland and Labrador | |
| Research Site | |
| St. John's, Newfoundland and Labrador, Canada | |
| Canada, Ontario | |
| Research Site | |
| Brampton, Ontario, Canada | |
| Research Site | |
| Burlington, Ontario, Canada | |
| Research Site | |
| Concord, Ontario, Canada | |
| Research Site | |
| Hamilton, Ontario, Canada | |
| Research Site | |
| Kitchener, Ontario, Canada | |
| Research Site | |
| Nepean, Ontario, Canada | |
| Research Site | |
| Newmarket, Ontario, Canada | |
| Research Site | |
| Ottawa, Ontario, Canada | |
| Research Site | |
| Toronto, Ontario, Canada | |
| Research Site | |
| Windsor, Ontario, Canada | |
| Canada, Quebec | |
| Research Site | |
| Laval, Quebec, Canada | |
| Research Site | |
| Montreal, Quebec, Canada | |
| Research Site | |
| Sherbrooke, Quebec, Canada | |
| Research Site | |
| Trois-Rivieres, Quebec, Canada | |
| Canada, Saskatchewan | |
| Research Site | |
| Saskatoon, Saskatchewan, Canada | |
Sponsors and Collaborators
Amgen
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00127842 History of Changes |
| Other Study ID Numbers: | 20040131 |
| Study First Received: | August 5, 2005 |
| Last Updated: | November 12, 2009 |
| Health Authority: | Canada: Health Canada Canada: Institutional Review Board |
Keywords provided by Amgen:
|
Psoriatic Arthritis PsA Commercial product American College of Rheumatology ACR/PASI |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases TNFR-Fc fusion protein Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Gastrointestinal Agents Immunologic Factors Immunosuppressive Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013