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
Show 43 Study Locations
Show 43 Study LocationsSponsors 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 June 17, 2013