Back to results

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

Primary Purpose

Psoriatic Arthritis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Alefacept

Methotrexate

Placebo

About this trial

This is an interventional treatment trial for Psoriatic Arthritis focused on measuring Psoriatic arthritis, psoriasis, Alefacept

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Course A1

Course A2

Course B

Arm Description

Open-label extension

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25

Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear

Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)

Full Information

NCT ID

NCT00659412

First Posted

April 14, 2008

Last Updated

September 17, 2014

Sponsor

Astellas Pharma Inc

Collaborators

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00659412

Brief Title

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

2. Study Status

Record Verification Date

September 2014

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

March 2005 (Actual)

Study Completion Date

March 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

Collaborators

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriatic Arthritis

Keywords

Psoriatic arthritis, psoriasis, Alefacept

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

185 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Course A1

Arm Type

Experimental

Arm Title

Course A2

Arm Type

Placebo Comparator

Arm Title

Course B

Arm Type

Experimental

Arm Description

Open-label extension

Intervention Type

Drug

Intervention Name(s)

Alefacept

Other Intervention Name(s)

Amevive, ASP0485

Intervention Description

Intramuscular

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Intramuscular

Primary Outcome Measure Information:

Title

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

Time Frame

12 Weeks and at any time

Secondary Outcome Measure Information:

Title

Proportion of patients achieving a score in the Psoriasis Area and Severity Index of PASI 75, PASI 50 and PASI 25

Time Frame

Each scheduled efficacy visit

Title

Proportion of patients achieving a classification in the Physician's Global Assessment (PGA) of clear/almost clear

Time Frame

Each scheduled efficacy visit

Title

Sharp -VanDen Heijde Modified Score of Joint Damage (X-ray)

Time Frame

Baseline, 24 Weeks and 48 Weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Use Central Contact

Organizational Affiliation

Astellas Pharma US, Inc.

Official's Role

Study Director

Facility Information:

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

City

Wheaton

State/Province

Maryland

ZIP/Postal Code

20902

Country

United States

City

Lake Success

State/Province

New York

ZIP/Postal Code

11042

Country

United States

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

City

Seattle

State/Province

Washington

ZIP/Postal Code

98104

Country

United States

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3P9

Country

Canada

City

St Johns

State/Province

Newfoundland and Labrador

ZIP/Postal Code

A1C 5B8

Country

Canada

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

City

Newmarket

State/Province

Ontario

ZIP/Postal Code

L3Y 3R7

Country

Canada

City

Toronto

State/Province

Ontario

ZIP/Postal Code

K1N 5N1

Country

Canada

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2L 1S6

Country

Canada

City

Berlin

ZIP/Postal Code

D-13125

Country

Germany

City

Frankfurt

ZIP/Postal Code

D-60590

Country

Germany

City

Goettingen

ZIP/Postal Code

D-37075

Country

Germany

City

Bialystok

ZIP/Postal Code

15-337

Country

Poland

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

City

Kalisz

ZIP/Postal Code

62-800

Country

Poland

City

Krakow

ZIP/Postal Code

30-119

Country

Poland

City

Torun

ZIP/Postal Code

87-100

Country

Poland

City

Warszawa

ZIP/Postal Code

02-637

Country

Poland

City

Moscow

ZIP/Postal Code

107076

Country

Russian Federation

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

City

N. Novgorod

ZIP/Postal Code

603600

Country

Russian Federation

City

St Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

City

St. Petersburg

ZIP/Postal Code

194044

Country

Russian Federation

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

12. IPD Sharing Statement

Citations:

PubMed Identifier

16646026

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.

Results Reference

background

PubMed Identifier

19028407

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.

Results Reference

background

Links:

URL

http://www.clinicaltrials.jp/user/ctrSearch_e.jsp

Description

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

Learn more about this trial

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

We'll reach out to this number within 24 hrs