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Sponsors and Collaborators: |
Innovaderm Research Inc. Amgen |
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Information provided by: | Innovaderm Research Inc. |
ClinicalTrials.gov Identifier: | NCT00640393 |
This study will provide data on the addition of nbUVB phototherapy to patients who have not shown an excellent response to three months of etanercept.
Condition | Intervention | Phase |
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Psoriasis Vulgaris |
Drug: Etanercept 50 mg Device: nbUVB |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Study Combining Etanercept and Short Courses of Narrow-Band UVB in Patients With Psoriasis Vulgaris |
Estimated Enrollment: | 98 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Etanercept: Active Comparator
Etanercept 50 mg Alone once a week.
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Drug: Etanercept 50 mg
All patients will receive Etanercept from Day 0 until Day 84. Patients who do not reach PASI 90 will be randomized to etanercept 50mg weekly.
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Etanercept and nbUVB: Active Comparator
Patients randomized to the nbUVB group will receive nbUVB treatments three times a week and 50 mg Etanercept once per week.
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Drug: Etanercept 50 mg
All patients will receive Etanercept from Day 0 until Day 84. Patients who do not reach PASI 90 will be randomized to etanercept 50mg weekly and nbUVB treatments three times a week.
Device: nbUVB
All patients will receive Etanercept from Day 0 until Day 84. Patients who do not reach PASI 90 will be randomized to etanercept 50mg weekly and nbUVB treatments three times a week.
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All patients will receive etanercept 50 mg twice a week for 12 weeks. Patients who reach PASI-90 at Day 84 will be discontinued from the study (they can continue receiving commercial etanercept outside the study). Patients remaining in the study at Day 84 will decrease etanercept to 50 mg weekly for another 12 weeks.
Patients who do not reach PASI-90 after 12 weeks will be randomized (1:1) to receive either etanercept alone or etanercept with short courses of nbUVB. Patients randomized to the nbUVB group will receive nbUVB treatments three times a weeks for at least four weeks. At every planned study visit after Day 84, nbUVB treatment will be discontinued in patients who reach PASI-90. nbUVB phototherapy will be re-initiated for another four weeks at the following planned study visit if they lose their PASI-90 response.
Efficacy will be evaluated with PASI, BSA and PGA by a blinded evaluator at Days 0, 28, 84, 112, 140 and 168. The effect of the treatment on quality of life will be evaluated using the DLQI questionnaire at Days 112, 140 and 168. Safety will be evaluated by physical examination and adverse events evaluation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada | |
Centre de Recherche Dermatologique du Quebec Metropolitain | |
Quebec, Canada, G1V 4X7 | |
Canada, British Columbia | |
PerCuro Clinical research Ltd. | |
Victoria, British Columbia, Canada, V8V 3P9 | |
Canada, Manitoba | |
Winnipeg Clinic | |
Winnipeg, Manitoba, Canada, R3C 0N2 | |
Canada, Ontario | |
Lynderm Research Inc. | |
Markham, Ontario, Canada, L3P 1A8 | |
Bank on Beauty | |
Niagara Falls, Ontario, Canada, L2E 2R4 | |
Mediprobe Research inc. | |
London, Ontario, Canada, N5X 2P1 | |
Sudbury Skin Clinic | |
Sudbury, Ontario, Canada, P3E 5M4 | |
The Guenther Dermatology Research Centre | |
London, Ontario, Canada, N6A 3H7 | |
Canada, Quebec | |
Innovaderm Research Inc | |
Laval, Quebec, Canada, H7S 2C6 | |
Innovaderm Research Inc. | |
Montreal, Quebec, Canada, H2K 4L5 | |
Clinique Dermatologique Fleury | |
Montreal, Quebec, Canada, H2C 1R9 |
Principal Investigator: | Robert Bissonnette, MD | Innovaderm Research Inc. |
Responsible Party: | Innovaderm Research Inc ( Robert Bissonnette ) |
Study ID Numbers: | Inno-6007 |
Study First Received: | March 18, 2008 |
Last Updated: | August 25, 2009 |
ClinicalTrials.gov Identifier: | NCT00640393 History of Changes |
Health Authority: | Canada: Ethics Review Committee |
Etanercept, UVB, Enbrel, Psoriasis. |
Anti-Inflammatory Agents Immunologic Factors Skin Diseases Analgesics, Non-Narcotic Psoriasis Anti-Inflammatory Agents, Non-Steroidal |
Peripheral Nervous System Agents Analgesics Antirheumatic Agents TNFR-Fc fusion protein Immunosuppressive Agents Skin Diseases, Papulosquamous |
Anti-Inflammatory Agents Immunologic Factors Skin Diseases Physiological Effects of Drugs Gastrointestinal Agents TNFR-Fc fusion protein Immunosuppressive Agents Pharmacologic Actions Psoriasis |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents Skin Diseases, Papulosquamous |