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Abatacept and Infliximab in Combination With Methotrexate in Subjects With Rheumatoid Arthritis
This study has been completed.
First Received: November 1, 2004   Last Updated: October 12, 2009   History of Changes
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:


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

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Locations
United States, Alabama
Local Institution
Huntsville, Alabama, United States
United States, Colorado
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Denver, Colorado, United States
United States, Florida
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Boca Raton, Florida, United States
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Ft Lauderdale, Florida, United States
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Largo, Florida, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Louisiana
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New Orleans, Louisiana, United States
United States, Massachusetts
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Worcester, Massachusetts, United States
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Springfield, Massachusetts, United States
United States, Mississippi
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Flowood, Mississippi, United States
United States, New York
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Syracuse, New York, United States
United States, North Carolina
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Charlotte, North Carolina, United States
United States, Ohio
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Cincinnati, Ohio, United States
United States, Oklahoma
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
United States, Pennsylvania
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Bethlehem, Pennsylvania, United States
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Willow Grove, Pennsylvania, United States
United States, Texas
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Austin, Texas, United States
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dallas, Texas, United States
Argentina
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Buenos Aires, Argentina
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Cordoba, Argentina
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Tucuman, Argentina
Argentina, Buenos Aires
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Capital Federal, Buenos Aires, Argentina
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Quilmes, Buenos Aires, Argentina
Australia, Queensland
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Cairns, Queensland, Australia
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Cotton Tree, Queensland, Australia
Australia, Victoria
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Clayton, Victoria, Australia
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Heidelberg, Victoria, Australia
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Malvern, Victoria, Australia
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Parkville, Victoria, Australia
Australia, Western Australia
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Perth, Western Australia, Australia
Brazil
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Rio De Janeiro, Brazil
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Sao Paulo, Brazil
Brazil, Parana
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Curitiba, Parana, Brazil
Brazil, Pernambuco
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Recife, Pernambuco, Brazil
Brazil, Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil
Canada
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Kitchener, Canada, ON
Canada, Alberta
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Newfoundland and Labrador
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St. Johns, Newfoundland and Labrador, Canada
Canada, Ontario
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Hamilton, Ontario, Canada
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Ottawa, Ontario, Canada
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Kitchener, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
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Ste-Foy, Quebec, Canada
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada
Czech Republic
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Prague 2, Czech Republic
Denmark
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Copenhagen, Denmark
Korea, Republic of
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Seoul, Korea, Republic of
Mexico
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San Luis Potosi, Mexico
Mexico, Baja California
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Tijuana, Baja California, Mexico
Mexico, Distrito Federal
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Mexico, Distrito Federal, Mexico
Mexico, Guanajuato
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Leon, Guanajuato, Mexico
Mexico, Jalisco
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Guadalajara, Jalisco, Mexico
Mexico, Nuevo Leon
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Monterrey, Nuevo Leon, Mexico
Peru
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Lima, Peru
Poland
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Poznan, Poland
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Sopot, Poland
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Warszawa, Poland
Puerto Rico
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Rio Piedras, Puerto Rico
Russian Federation
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Moscow, Russian Federation
South Africa, Gauteng
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Muckleneuk, Gauteng, South Africa
South Africa, Kwa Zulu Natal
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Berea, Kwa Zulu Natal, South Africa
South Africa, Western Cape
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Panorama, Western Cape, South Africa
Spain
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A Coruna, Spain
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Barcelona, Spain
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Cordoba, Spain
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Madrid, Spain
Sweden
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Falun, Sweden
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Linkoping, Sweden
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Lund, Sweden
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Stockholm, Sweden
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Uppsala, Sweden
Switzerland
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Bern, Switzerland
Local Institution
St. Gallen, Switzerland
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

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