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

Study Overview
=================
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.

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

Conditions
-----------------
Psoriatic Arthritis

Intervention / Treatment
-----------------
* Drug: Alefacept
* Drug: Methotrexate
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Course A1<br> | Drug: Alefacept<br>* Intramuscular<br>* Other names: Amevive, ASP0485;Drug: Methotrexate<br>* Oral<br>|
| Placebo Comparator: Course A2<br> | Drug: Methotrexate<br>* Oral<br>Drug: Placebo<br>* Intramuscular<br>|
| Experimental: Course B<br>Open-label extension | Drug: Alefacept<br>* Intramuscular<br>* Other names: Amevive, ASP0485;Drug: Methotrexate<br>* Oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear |  | Each scheduled efficacy visit | 
| Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray) |  | Baseline, 24 Weeks and 48 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriatic arthritis, psoriasis, Alefacept