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

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00095147

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Abatacept + Methotrexate Drug: Infliximab + Methotrexate Drug: Placebo + Methotrexate Drug: Abatacept	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Infliximab Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	400
Study Start Date:	February 2005
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Abatacept + Methotrexate: Active Comparator Short Term Portion of the Study	Drug: Abatacept + Methotrexate IV Solution, Infusion, Depends on subject weight, Monthly, 12 months.
Infliximab + Methotrexate: Active Comparator Short Term Portion of the Study	Drug: Infliximab + Methotrexate IV Solution, Infusion, Depends on subject weight, Every 2 Months, 12 months.
Placebo + Methotrexate: Placebo Comparator Short Term Portion of the Study	Drug: Placebo + Methotrexate IV Solution, Infusion, Depends on subject weight, Monthly, 6 months.
Abatacept: Experimental Long Term Portion of the Study All subjects receive Active Drug	Drug: Abatacept IV solution, Infusion. Deptends on subject weight, Monthly, 12+ months

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00095147

Show 76 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-043
Study First Received:	November 1, 2004
Last Updated:	October 12, 2009
ClinicalTrials.gov Identifier:	NCT00095147 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Infliximab
Antineoplastic Agents
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
Abatacept
Musculoskeletal Diseases
Arthritis
Therapeutic Uses
Abortifacient Agents

Connective Tissue Diseases
Methotrexate
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on November 27, 2009