Safety and Efficacy of Abatacept Versus Placebo in Subjects With Psoriatic Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 20, 2007

Last Updated Date

September 28, 2009

Start Date ^ICMJE

November 2007

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Primary outcome measure is response of arthritis, as measured by ACR20 response rate [ Time Frame: every month, 6 months double-blind ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Primary outcome measure is response of arthritis, as measured by ACR20 response rate [ Time Frame: every month, 6 months double-blind ]

Change History

Complete list of historical versions of study NCT00534313 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Response of the psoriatic skin lesions, as measured by Investigators' Global Assessment (IGA) [ Time Frame: every month ] [ Designated as safety issue: No ]
HAQ [ Time Frame: every month ] [ Designated as safety issue: No ]
SF-36 [ Time Frame: every month ] [ Designated as safety issue: No ]
Response of psoriatic Target lesion [ Time Frame: every month ] [ Designated as safety issue: No ]
Proportion with ACR20, ACR50, ACR70, ACR 90 responses [ Time Frame: at Days 365 and 729 ] [ Designated as safety issue: No ]
Proportion with IGA score of clear or almost clear [ Time Frame: at Days 365 and 729 ] [ Designated as safety issue: No ]
Mean percentage change from baseline in target lesion [ Time Frame: at Days 365 and 729 ] [ Designated as safety issue: No ]
Mean changes from baseline in physical and mental summary functions of SF-36 [ Time Frame: at Days 365 and 729 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Response of the psoriatic skin lesions, as measured by Investigators' Global Assessment (IGA) [ Time Frame: every month ]
HAQ [ Time Frame: every month ]
SF-36 [ Time Frame: every month ]
Response of psoriatic Target lesion [ Time Frame: every month ]

Descriptive Information

Brief Title ^ICMJE

Safety and Efficacy of Abatacept Versus Placebo in Subjects With Psoriatic Arthritis

Official Title ^ICMJE

A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis

Brief Summary

The purpose of this study is to determine an optimal abatacept dosing regimen for the treatment of patients with active arthritis due to psoriatic arthritis who have had a prior inadequate response to DMARDs, including (but not limited to) methotrexate and TNF(alpha) blockade compounds.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Psoriatic Arthritis

Intervention ^ICMJE

Drug: Abatacept
Drug: placebo

Study Arms / Comparison Groups

Active Comparator:
Short Term/Double Blind Period

3 mg/kg calculated dose using the subject's body weight at screening

All arms (A1-A4): Open Label - Active study drug (solution, intravenous, Approximately 10 mg/kg fixed dose, based on subject's body weight; 500 mg for subjects weighing < 60kg; 750 mg for subjects weighing 60 to 100 kg; and 1 gram for subjects weighing > 100 kg, monthly, LT = 18 months)
Active Comparator:
10 mg/kg (fixed dose, based on subject's body weight at screening)

500 mg for subjects weighing < 60kg

750 mg for subjects weighing 60 to 100 kg

and 1 gram for subjects weighing > 100 kg
Active Comparator:
30 mg/kg (calculated dose using a subject's body weight at screening) on Days 1 and 15, followed by 10 mg/kg (fixed dose, based on subject's body weight at screening

500 mg for subjects weighing < 60kg

750 mg for subjects weighing 60 to 100 kg

and 1 gram for subjects weighing > 100 kg

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

170

Estimated Completion Date

October 2010

Estimated Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Clinical diagnosis of psoriatic arthritis
Active arthritis
Active psoriasis
Prior failure of DMARD therapy (methotrexate, TNF blockade or other)
For women of child bearing potential-must use appropriate birth control

Exclusion Criteria:

Drug or alcohol abuse
Severe uncontrolled underlying medical conditions
Cancer within the last 5 years
Unable/ unwilling to undergo locally prescribed routine cancer screening
At risk for contracting TB
Evidence of active or latent bacterial or viral infection
Recent significant bacterial infection within 3 months of the anticipated first dose
Live vaccine within 3 months of the anticipated first dose

LT/Open-Label: Must have met eligibility criteria for ST and completed ST/Double-Blind (24-week) phase of the study

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Belgium, Canada, France, Germany, Italy, Netherlands, Norway, South Africa, Spain

Administrative Information

NCT ID ^ICMJE

NCT00534313

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

IM101-158, EUDRACT 2007-004241-15

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

September 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP