A Placebo-controlled Study With an Extension Examining the Safety and Efficacy of Alefacept in Psoriatic Arthritis
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
1 other identifier
interventional
185
5 countries
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2003
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
April 14, 2008
CompletedFirst Posted
Study publicly available on registry
April 16, 2008
CompletedSeptember 18, 2014
September 1, 2014
1.5 years
April 14, 2008
September 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (3)
Course A1
EXPERIMENTALCourse A2
PLACEBO COMPARATORCourse B
EXPERIMENTALOpen-label extension
Interventions
Eligibility Criteria
You may qualify if:
- Psoriatic arthritis
- MTX treatment for 3 months prior to enrollment with continuing disease
- Normal T-cell count
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Biogencollaborator
Study Sites (27)
Unknown Facility
Birmingham, Alabama, 35294, United States
Unknown Facility
Wheaton, Maryland, 20902, United States
Unknown Facility
Lake Success, New York, 11042, United States
Unknown Facility
Rochester, New York, 14642, United States
Unknown Facility
Seattle, Washington, 98104, United States
Unknown Facility
Victoria, British Columbia, V8V 3P9, Canada
Unknown Facility
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Unknown Facility
London, Ontario, N6A 4V2, Canada
Unknown Facility
Newmarket, Ontario, L3Y 3R7, Canada
Unknown Facility
Toronto, Ontario, K1N 5N1, Canada
Unknown Facility
Toronto, Ontario, M5T 2S8, Canada
Unknown Facility
Montreal, Quebec, H2L 1S6, Canada
Unknown Facility
Berlin, D-13125, Germany
Unknown Facility
Frankfurt, D-60590, Germany
Unknown Facility
Göttingen, D-37075, Germany
Unknown Facility
Bialystok, 15-337, Poland
Unknown Facility
Elblag, 82-300, Poland
Unknown Facility
Kalisz, 62-800, Poland
Unknown Facility
Krakow, 30-119, Poland
Unknown Facility
Torun, 87-100, Poland
Unknown Facility
Warsaw, 02-637, Poland
Unknown Facility
Moscow, 107076, Russia
Unknown Facility
Moscow, 115522, Russia
Unknown Facility
Nizhny Novgorod, 603600, Russia
Unknown Facility
Saint Petersburg, 190068, Russia
Unknown Facility
Saint Petersburg, 194044, Russia
Unknown Facility
Yaroslavl, 150003, Russia
Related 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. doi: 10.1002/art.21870.
PMID: 16646026BACKGROUNDMease 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.
PMID: 19028407BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Use Central Contact
Astellas Pharma US, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2008
First Posted
April 16, 2008
Study Start
September 1, 2003
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
September 18, 2014
Record last verified: 2014-09