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| Sponsor: | Abbott |
|---|---|
| Information provided by: | Abbott |
| ClinicalTrials.gov Identifier: | NCT00513370 |
Purpose
To evaluate the safety profile, the effectiveness and the economic impact of adalimumab when used for the treatment of subjects with active plaque psoriasis who have not adequately responded to prior psoriasis therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Biological: Humira (adalimumab) |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Canadian Open-Label Access Program to Evaluate the Safety and the Effectiveness of Adalimumab When Added to Inadequate Therapy for the Treatment of Psoriasis |
| Enrollment: | 203 |
| Study Start Date: | September 2007 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Biological: Humira (adalimumab)
Study drug will be provided as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). Loading dose of 80 mg of adalimumab subcutaneously (sc) at Baseline, and 40 mg of adalimumab sc at Week 1, followed by 40 mg of adalimumab sc every other week (eow) for 24 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Subject has failed to respond to, is intolerant to or has contraindication for at least two of the following therapies:
If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:
Exclusion Criteria:
Topical therapies:
Oral or injectable corticosteroids therapies:
Phototherapies
Systemic Therapies:
Subject cannot discontinue the following systemic psoriasis therapies:
Subject has a history of cancer or lymphoproliferative disease other than:
Contacts and Locations| Canada | |
| Quebec, Canada, G1J 1X7 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T3A 2N1 | |
| Calgary, Alberta, Canada, T2S 3B3 | |
| Edmonton, Alberta, Canada, T5K 1X3 | |
| Canada, British Columbia | |
| Surrey, British Columbia, Canada, V3R 6A7 | |
| Vancouver, British Columbia, Canada, V5Z 4E8 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3C 1R4 | |
| Winnipeg, Manitoba, Canada, R3C 0N2 | |
| Canada, New Brunswick | |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Canada, Newfoundland and Labrador | |
| St. John's, Newfoundland and Labrador, Canada, A1C 2H5 | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3E1 | |
| Canada, Nova Scotia | |
| Halifax, Nova Scotia, Canada, B3H 1Z4 | |
| Canada, Ontario | |
| Hamilton, Ontario, Canada, L8N 1V6 | |
| London, Ontario, Canada, N5X 2P1 | |
| London, Ontario, Canada, N6A 3H7 | |
| Oakville, Ontario, Canada, L6K 1E1 | |
| Markham, Ontario, Canada, L3P 1A8 | |
| Barrie, Ontario, Canada, L4M 6L2 | |
| Fenwick, Ontario, Canada, L0S 1C0 | |
| Oakville, Ontario, Canada, L6J 7W5 | |
| Nepean, Ontario, Canada, K2G 6E2 | |
| North Bay, Ontario, Canada, P1B 3Z7 | |
| Toronto, Ontario, Canada, M4V 1R1 | |
| Waterloo, Ontario, Canada, N2J 1C4 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H3Z 2S6 | |
| Ste-Foy, Quebec, Canada, G1V 4X7 | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Principal Investigator: | Kim Papp, MD PhD FRCPC | K. Papp Clinical Research Inc. |
More Information
| Responsible Party: | Abbott ( Isabel Pereira, Affiliate Project Manager ) |
| Study ID Numbers: | W10-151 |
| Study First Received: | August 6, 2007 |
| Results First Received: | August 21, 2009 |
| Last Updated: | October 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00513370 History of Changes |
| Health Authority: | Canada: Health Canada |
|
Psoriasis adalimumab |
|
Anti-Inflammatory Agents Skin Diseases Psoriasis Therapeutic Uses |
Antirheumatic Agents Adalimumab Skin Diseases, Papulosquamous Pharmacologic Actions |