A Phase III Study of BMS-188667 in Patients With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00048568

Purpose

The purpose of this clinical research study is to learn if BMS-188667 in combination with methotrexate is better than methotrexate alone in subjects that have active rheumatoid arthritis and are not responding to methotrexate. The safety of this treatment will also be studied.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: BMS-188667 Drug: Methotrexate Drug: Placebo	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Abatacept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator)

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

ACR 20

Secondary Outcome Measures:

X-Ray of hand & feet; ACR20, ACR50, ACR70, DAS-28

Arms	Assigned Interventions
A1: Experimental	Drug: BMS-188667 IV Solution, Intravenous, - Weight Titered (500 mg < 60 kg); (750 mg 60-100 kg), )1 gram > 100 kg), Day 1, Day 15, Day 29; every 18 days thereafter, 1 year (+LTE) Drug: Methotrexate Tablets, Oral, >= 15 mg, weekly, 1 year (+LTE)
A2: Placebo Comparator	Drug: Methotrexate Tablets, Oral, >= 15 mg, weekly, 1 year (+LTE) Drug: Placebo IV solution, Intravenous, D5W, Day 1, Day 15, Day 29; every 28 days thereafter, 1 year

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Rheumatoid Arthritis for greater than 1 year from the time of initial diagnosis of RA.
Patients must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00048568

Show 48 Study Locations

Sponsors and Collaborators

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

Publications:

Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechinski J, Li T, Ge Z, Becker JC, Westhovens R. Effects of abatacept in patients with methotrexate-resistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006 Jun 20;144(12):865-76. Summary for patients in: Ann Intern Med. 2006 Jun 20;144(12):I18.

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

Kremer JM, Genant HK, Moreland LW, Russell AS, Emery P, Abud-Mendoza C, Szechiński J, Li T, Teng J, Becker JC, Westhovens R. Results of a two-year followup study of patients with rheumatoid arthritis who received a combination of abatacept and methotrexate. Arthritis Rheum. 2008 Apr;58(4):953-63.

Study ID Numbers:	IM101-102
Study First Received:	November 2, 2002
Last Updated:	October 8, 2008
ClinicalTrials.gov Identifier:	NCT00048568 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Antimetabolites
Autoimmune Diseases
Immunologic Factors
Joint Diseases
Arthritis, Rheumatoid
Rheumatic Diseases
Folic Acid Antagonists
Immunosuppressive Agents

Folic Acid
Abatacept
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate
Antirheumatic Agents

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
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
Enzyme Inhibitors
Rheumatic Diseases
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on May 07, 2009