Open-label Study to Evaluate Safety of Multiple Courses of IM Alefacept During Treatment of Chronic Plaque Psoriasis
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Biogen Idec
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00692172
First received: June 4, 2008
Last updated: November 3, 2010
Last verified: June 2008
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Purpose
An extension study to evaluate safety and tolerability of up to 3 additional courses of IM alefacept in patients with chronic plaque psoriasis who have been previously treated with 1 or 2 courses of IM alefacept.
| Condition | Intervention | Phase |
|---|---|---|
|
Psoriasis |
Drug: Alefacept |
Phase 3 |
| 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: | An Open-Label, Multi-center Study to Evaluate the Safety and Tolerability of Intramuscular Administration of Alefacept (LFA-3/IgG1 Fusion Protein) in Subjects With Chronic Plaque Psoriasis Who Have Completed Studies C99-717 or C99-712 |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
Primary Outcome Measures:
- Assessment of safety including evaluation of incidence of adverse events, physical exams and laboratory monitoring [ Time Frame: Throughout treatment course ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects who achieved "Almost Clear" or "Clear" by Physicians' Global Assessment [ Time Frame: Every 2 weeks throughout treamtent course ] [ Designated as safety issue: No ]
| Enrollment: | 175 |
| Study Start Date: | December 2001 |
| Study Completion Date: | November 2004 |
| Primary Completion Date: | November 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Alefacept
intramuscular injection (IM)
Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Must have received at least 8 injections in the C99-717 study and completed the final follow-up visit OR,
- Must have completed the C99-712 study and been in C99-717 interim visits at the time dosing in the C99-717 study was closed. A subject who completed C99-712 but did not participate in any part of C99-717, including interim visits, must have prior sponsor approval before admission into C-728
Exclusion Criteria:
- Nursing mothers, pregnant women, and women planning to become pregnant while on study are to be excluded. Female patients who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study
- Clinically significant abnormal hematology values or history of an immunosuppressive disorder
- Serious local infection or systemic infection within 3 months prior to the first dose of alefacept
- A significant change in the subject's medical history from their previous alefacept study
- Any subject who initiated alternative systemic therapy, phototherapy, or disallowed therapy prior to visit 8 in study C99-712 or C99-717
- Current enrollment in any investigational study in which the subject is receiving any type of drug, biologic, or non-drug therapy (participation in registry-type studies is allowed)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00692172
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Hide Study LocationsLocations
| United States, Arkansas | |
| Hot Springs, Arkansas, United States, 71913 | |
| United States, California | |
| Fresno, California, United States, 93710 | |
| La Jolla, California, United States, 92037 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Jacksonville, Florida, United States, 32204 | |
| Pinellas Park, Florida, United States, 33781 | |
| United States, Georgia | |
| Newnan, Georgia, United States, 30263 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60611 | |
| United States, Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| United States, Michigan | |
| Clinton Township, Michigan, United States, 48038 | |
| United States, Missouri | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nebraska | |
| Omaha, Nebraska, United States, 68131 | |
| United States, New Jersey | |
| Berlin, New Jersey, United States, 08009 | |
| United States, Oregon | |
| Lake Oswego, Oregon, United States, 79035 | |
| Portland, Oregon, United States, 97210 | |
| United States, Rhode Island | |
| Johnston, Rhode Island, United States, 02919 | |
| United States, Tennessee | |
| Goodlettsville, Tennessee, United States, 37072 | |
| United States, Texas | |
| Austin, Texas, United States, 78759 | |
| San Antonio, Texas, United States, 78229 | |
| Belgium | |
| Brussels, Belgium, B-1070 | |
| Edegem, Belgium, B-2650 | |
| Liege, Belgium, 4000 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T2S 3B3 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3C ON2 | |
| Canada, New Brunswick | |
| Moncton, New Brunswick, Canada, E1C 8X3 | |
| Canada, Newfoundland and Labrador | |
| St. John's, Newfoundland and Labrador, Canada, A1B 4S8 | |
| Canada, Ontario | |
| London, Ontario, Canada, N6A 3H7 | |
| Waterloo, Ontario, Canada, N2J 1C | |
| Windsor, Ontario, Canada, N8W 5L7 | |
| Canada, Quebec | |
| Sainte-Foy, Quebec, Canada, G1V 4X7 | |
| Denmark | |
| Copenhagen, Denmark, DK-2400 | |
| France | |
| Besancon, France, 25030 | |
| Brest, France, 29279 | |
| Nice, France, 06202 | |
| Paris, France, 75475 | |
| Tours, France, 37044 | |
| Germany | |
| Bochum, Germany, 44791 | |
| Dresden, Germany, 01307 | |
| Munich, Germany, 80337 | |
| Netherlands | |
| Amsterdam, Netherlands, 1100 DE | |
| Spain | |
| Madrid, Spain, 28006 | |
| Valencia, Spain, 46014 | |
| United Kingdom | |
| Liverpool, United Kingdom, L14 3LB | |
Sponsors and Collaborators
Astellas Pharma Inc
Biogen Idec
Investigators
| Study Director: | Central Contact | Astellas Pharma US, Inc. |
More Information
No publications provided
| Responsible Party: | Sr Manager Clinical Trial Registry, Astellas Pharma US, Inc |
| ClinicalTrials.gov Identifier: | NCT00692172 History of Changes |
| Other Study ID Numbers: | C-728 |
| Study First Received: | June 4, 2008 |
| Last Updated: | November 3, 2010 |
| Health Authority: | United States: Food and Drug Administration Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines Canada: Health Canada Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) Belgium: Federal Agency for Medicinal Products and Health Products France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Denmark: Danish Medicines Agency United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Astellas Pharma Inc:
|
psoriasis alefacept intramuscular |
Additional relevant MeSH terms:
|
Psoriasis Skin Diseases, Papulosquamous Skin Diseases Alefacept |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013