Clinical trial NCT00659412: A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Psoriatic Arthritis
Keywords: Psoriatic arthritis
psoriasis
Alefacept
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2008-04-16
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 Weeks and at any time
Secondary outcomes:
measure: Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25
timeFrame: Each scheduled efficacy visit
measure: Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear
timeFrame: Each scheduled efficacy visit
measure: Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)
timeFrame: Baseline, 24 Weeks and 48 Weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Wheaton
country: United States
state: Maryland
city: Lake Success
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Seattle
country: United States
state: Washington
city: Victoria
country: Canada
state: British Columbia
city: St Johns
country: Canada
state: Newfoundland and Labrador
city: London
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Berlin
country: Germany
city: Frankfurt
country: Germany
city: Goettingen
country: Germany
city: Bialystok
country: Poland
city: Elblag
country: Poland
city: Kalisz
country: Poland
city: Krakow
country: Poland
city: Torun
country: Poland
city: Warszawa
country: Poland
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: N. Novgorod
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St. Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
Study officials:
affiliation: Astellas Pharma US, Inc.
name: Use Central Contact
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1002/art.21870.
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.