Alefacept in Subjects With Chronic Plaque Psoriasis Who Failed to Respond to Anti-TNF Therapy

NCT00953329 | Terminated Phase 4 Results

• 3 other identifiers: Pro00002474Funding Agency # ER-07-001IND # 100770
• Study Type: interventional
• Target: 1
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study Status: Duke University Health System Institutional Review Board has received notification of study termination; final IRB closure date is 12/12/2008. Study enrollment is now closed. Enrollment Update: Only one subject was entered into this study out of an expected enrollment of 15 patients in this single site clinical trial. With no recruitment interest, the financial sponsor and Sponsor-PI chose to close the clinical trial.

Conditions

Chronic Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• Treatment Alefacept

  Terminated study

  12 weeks (study terminated)

Study Arms (1)

Alefacept 15 mg IM qweek

EXPERIMENTAL

Alefacept will be given to subjects with plaque psoriasis who have failed treatment with Fnbrel.

Drug: alefacept

Interventions

alefacept DRUG

Alefacept 15 mg IM once a week were to be administered for 12 weeks, which is the FDA approved dosage, duration, and frequency. This study allowed an additional 8 doses if subject did not achieve a 'clear' response with the original 12 weeks of treatment. Each enrolled subject must have failed a response to anti-TNF therapy prior to entering this study.

Also known as: Amevive

Alefacept 15 mg IM qweek

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between ages of 18 and 80 years
• Subjects diagnosed with chronic plaque psoriasis who require systemic therapy.
• Must be receiving anti-TNF treatment without achieving response of 'almost clear' or 'clear' according to PGA or has not responded with 75% reduction PASI score.
• Must be willing to receive up to 20 weeks of IM injections weekly
• CD4 counts must be above 250 cells/mm3 at screening

You may not qualify if:

• Diagnosis of unstable erythroderma or pustular psoriasis or guttate psoriasis
• Serious local infection or systemic infection 3 months prior to receiving study drug.
• Subjects with CD4 lymphocyte count less than 250 cells/mm3 at study entry

Sponsors & Collaborators

• John Murray: lead
• Astellas Pharma US, Inc.: collaborator

MeSH Terms

Interventions

Alefacept

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Limitations and Caveats

Early termination due to one patient enrolled . The patient stopped the study because she was not improved and desired alternative treatment.

Results Point of Contact

• Title: Shirley Blalock
• Organization: DukeUMC

shirley.blalock@duke.edu

919-668-0999

Study Officials

• John C Murray, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Dermatology

Study Record Dates

• First Submitted: July 22, 2009
• First Posted: August 6, 2009
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 22, 2013
• Results First Posted: February 15, 2013

Record last verified: 2013-02