A Phase III Study of Abatacept in Patients With Rheumatoid Arthritis, With an Inadequate Response to Methotrexate - Full Text View

Purpose

The purpose of the study is to demonstrate the clinical efficacy of abatacept (fixed dose ~ 10mg/kg) compared with placebo on a background of methotrexate after six months of treatment in patients with active RA and an inadequate clinical response to methotrexate

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Placebo Drug: abatacept versus 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), Active Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	A Phase III, Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Abatacept Administered Intravenously in Korean Subjects With Active Rheumatoid Arthritis While Receiving Methotrexate

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The primary endpoint will be the proportion of subjects meeting the American College of Rheumatology criteria for 20% improvement (ACR 20) [ Time Frame: on Day 169 (Month 6) ] [ Designated as safety issue: No ]
Safety will be the primary endpoint [ Time Frame: During the twelve month open-label extension ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The evaluation for 50% Improvement (ACR 50) and 70% improvement (ACR 70) follow similarly [ Time Frame: upon occurence ] [ Designated as safety issue: No ]
Other responses (e.g. DAS-28), outcome measures (e.g. SF-36) and safety of the investigational product will also be evaluated [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Enrollment:	113
Study Start Date:	April 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Placebo Comparator	Drug: Placebo solution, intravenous, 0 mg, every 28 days, 6 months and 12 months open-label
A2: Placebo Comparator	Drug: abatacept versus placebo solution, intravenous, 10 mg, every 28 days, 6 months and 12 months open-label

Eligibility

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

Criteria

Inclusion Criteria:

Rheumatoid Arthritis for greater than 1 year from the time of the initial diagnosis of RA
Subjects must have been taking methotrexate for at least 3 months with at least a weekly dose of 15 mg, and a stable dose for 28 days prior to treatment (Day 1)
Methotrexate weekly dose as low as 10 mg is permitted for subjects who can not tolerate higher doses
Men and woman, 18 years of age or older

Exclusion Criteria:

Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00409838

Locations


Korea, Republic of
	Local Institution
	Seoul, Korea, Republic of, 137040
	Local Institution
	Seoul, Korea, Republic of, 110-744
	Local Institution
	Seoul, Korea, Republic of, 138-736
	Local Institution
	Daegu, Korea, Republic of, 705-718
	Local Institution
	Anyang, Korea, Republic of, 431-070
	Local Institution
	Daejeon, Korea, Republic of, 302-799

Korea, Republic of, Sungdong-Gu
	Local Institution
	Seoul, Sungdong-Gu, Korea, Republic of, 133-792

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

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

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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-124
First Received:	December 8, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00409838
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Rheumatoid Arthritis, with inadequate response to methotrexate

Study placed in the following topic categories:

Folic Acid

Abatacept

Autoimmune Diseases

Musculoskeletal Diseases

Joint Diseases

Arthritis

Connective Tissue Diseases

Arthritis, Rheumatoid

Methotrexate

Rheumatic Diseases

Additional relevant MeSH terms:

Antimetabolites

Antimetabolites, Antineoplastic

Immunologic Factors

Immune System Diseases

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Physiological Effects of Drugs

Enzyme Inhibitors

Reproductive Control Agents

Folic Acid Antagonists

Abortifacient Agents, Nonsteroidal

Immunosuppressive Agents

Pharmacologic Actions

Therapeutic Uses

Abortifacient Agents

Antirheumatic Agents

Dermatologic Agents

Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 22, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00409838