Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

November 1, 2004

Last Updated Date

October 12, 2009

Start Date ^ICMJE

February 2005

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To demonstrate that the Abatacept in combination with Methotraexate will demonstrate a greater reduction in disease activity than placebo in combination with methotrexate as measured by the Disease Activity Score (das28) [ Time Frame: at 6 months (Day 197) ] [ Designated as safety issue: No ]
Assess the safety and long-term tolerability of Abatacept in subjects who will continue in the long-term extention [ Time Frame: though July 2009 ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

TO DEMONSTRATE THAT THE ABATACEPT IN COMBINATION WITH METHOTREXATE WILL DEMONSTRATE A GREATER REDUCTION INDISEAE ACTIVITY THAN PLACEBO IN COMBINATION WITH METHOTREXATE AS MEASURED BY THE DISEASE ACTIVITY SCORE (das28) AT 6 MONTHS (Day 197).

Change History

Complete list of historical versions of study NCT00095147 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To demonstrate that infliximab in combination with methotrexate will demonstrate a greater reduction in disease activity than placebo in combination with methotrexate (mtx) as measured by the disease activity score (DASE28) [ Time Frame: at 6 months ] [ Designated as safety issue: Yes ]
Assess the immunogenicity of abatacept in combionation with methotrexate [ Time Frame: through July 2009 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

To demonstrate that infliximab in combination with methotrexate will demonstrate a greater reduction in disease activity than placebo in combination with methotrexate (mtx) as measured by the disease activity score (DASE28) at 6 months;

Descriptive Information

Brief Title ^ICMJE

Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

Official Title ^ICMJE

A Phase IIIB, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Comparative Study of Abatacept or Infliximab in Combination With Methotrexate in Controlling Disease Activity in Subjects With Rheumatoid Arthritis Having an Inadequate Clinical Response to Methotrexate

Brief Summary

The purpose of this clinical research study is to learn if Abatacept in combination with Methotrexate and Infliximab demonstrate a greater reduction in disease activity over placebo.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Abatacept + Methotrexate
Drug: Infliximab + Methotrexate
Drug: Placebo + Methotrexate
Drug: Abatacept

Study Arms / Comparison Groups

Active Comparator: Short Term Portion of the Study
Placebo Comparator: Short Term Portion of the Study
Experimental:
Long Term Portion of the Study

All subjects receive Active Drug

Publications *

Schiff M, Keiserman M, Codding C, Songcharoen S, Berman A, Nayiager S, Saldate C, Li T, Aranda R, Becker JC, Lin C, Cornet PL, Dougados M. Efficacy and safety of abatacept or infliximab vs placebo in ATTEST: a phase III, multi-centre, randomised, double-blind, placebo-controlled study in patients with rheumatoid arthritis and an inadequate response to methotrexate. Ann Rheum Dis. 2008 Aug;67(8):1096-103. Epub 2007 Nov 29.

* 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

Completed

Enrollment ^ICMJE

400

Completion Date

July 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of Rheumatoid Arthritis
At least 3 months prior treatment with Methotrexate (MTX)
At least 10 swollen joints and 12 tender joints and C-Reactive Protein of at least 1 mg/dl
Washout required for other disease modifying anti-rheumatic drugs (DMARDS)

Exclusion Criteria:

Subjects who have failed more than 3 DMARDs
Subjects previously treated with an approved biologic drug
History of cancer in the last 5 years
Severe or recurrent bacterial infection
Any previous or current medical conditions that are contraindications to the use of TNF blocking agents
Women of Child Bearing Potential

Gender

Both

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina, Australia, Brazil, Canada, Czech Republic, Denmark, Korea, Republic of, Mexico, Peru, Poland, Puerto Rico, Russian Federation, South Africa, Spain, Sweden, Switzerland

Administrative Information

NCT ID ^ICMJE

NCT00095147

Responsible Party

Study Director, Bristol-Myers Squibb

Study ID Numbers ^ICMJE

IM101-043

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

October 2009

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