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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00659412
Other study ID # C-737
Secondary ID
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


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
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