A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Alefacept When Given in Combination With Methotrexate in Subjects With Psoriatic Arthritis With an Open-label Retreatment Course

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00659412
• Other study ID #: C-737
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2008
• Last updated: September 17, 2014
• Start date: September 2003
• Est. completion date: March 2005

Study information

• Verified date: September 2014
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaRussia: Ministry of Health of the Russian FederationPoland: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Randomized, double-blind, 24-week study of patients with psoriatic arthritis comparing alefacept + methotrexate (MTX) vs. placebo + MTX followed by a 24-week open-label extension with only alefacept + MTX treatment.

Description:

Patients who completed the initial 24-week treatment course and met the inclusion and exclusion criteria for the 24 week open-label extension continued on their stable MTX dose and also received alefacept throughout this extension.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: March 2005
• Est. primary completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Psoriatic arthritis

• MTX treatment for 3 months prior to enrollment with continuing disease

• Normal T-cell count

Exclusion Criteria:

• Other types of psoriasis

• History of malignancy or lymphoproliferative disorder

• Serious infection or fever

• Antibody positive for Hepatitis C, HIV or TB

• Hepatic transaminases > 2X normal

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• Alefacept
Intramuscular
• Methotrexate
Oral
• Placebo
Intramuscular

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Biogen

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Poland,  Russian Federation, 

References & Publications (2)

Mease PJ, Gladman DD, Keystone EC; Alefacept in Psoriatic Arthritis Study Group. Alefacept in combination with methotrexate for the treatment of psoriatic arthritis: results of a randomized, double-blind, placebo-controlled study. Arthritis Rheum. 2006 May;54(5):1638-45. — View Citation

Mease PJ, Reich K; Alefacept in Psoriatic Arthritis Study Group. Alefacept with methotrexate for treatment of psoriatic arthritis: open-label extension of a randomized, double-blind, placebo-controlled study. J Am Acad Dermatol. 2009 Mar;60(3):402-11. doi: 10.1016/j.jaad.2008.09.050. Epub 2008 Nov 25. Erratum in: J Am Acad Dermatol. 2009 Sep;61(3):507. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients achieving a score in the assessment system of the American College of Rheumatology Core Set Measurements of ACR 20, ACR 50 and ACR 70		12 Weeks and at any time	No
Secondary	Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25		Each scheduled efficacy visit	No
Secondary	Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear		Each scheduled efficacy visit	No
Secondary	Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)		Baseline, 24 Weeks and 48 Weeks	No

External Links

•   Link to Results on JAPIC - enter 140597 in the JapicCTI-RNo. field