Remission in Early Rheumatoid Arthritis - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00122382

Purpose

This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: abatacept and methotrexate Drug: placebo and methotrexate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase IIIB Multi-Center, Randomized, Double-Blind Study to Evaluate Remission and Joint Damage Progression in Methotrexate Naive Early Erosive RA Subjects Treated With Abatacept Plus Methotrexate Compared With Methotrexate

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The proportion of subjects who achieve remission as defined by a DAS 28 score less that 2.6. [ Time Frame: in 12 months of treatment (Day 365) ] [ Designated as safety issue: No ]
Joint damage progression measured by radiographic evaluation using the Genant‑Modified Sharp total score [ Time Frame: at 12 months of treatment (Day 365) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare the proportion of subjects with an ACR50 response [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
Compare the proportion of subjects achieving major clinical response defined by 6 months of consecutive ACR 70 response [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
Compare the disease activity as measured by DAS 28 score [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
Compare the improvement in physical function using the HAQ disability index [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
Compare the improvement in health-related quality of life using SF-36 [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
Compare the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, and joint space narrowing [ Time Frame: at month 12 (Day 365) ] [ Designated as safety issue: No ]
Assess the inhibition of joint damage progression measured by radiographic evaluation using the Genant-modified Sharp erosion, joint space narrowing and total score [ Time Frame: at month 24 (Day 729) ] [ Designated as safety issue: No ]
Determine the safety and tolerability of abatacept in this subject population, including evaluation of immunogenicity of abatacept. [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]
Assess the improvement in physical function [ Time Frame: at month 24 (Day 729) ] [ Designated as safety issue: No ]

Estimated Enrollment:	750
Study Start Date:	July 2005
Estimated Study Completion Date:	January 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: abatacept and methotrexate abatacept: IV, 10mg/kg, monthly, 24 months methotrexate: Tablets, Oral, 20 mg MTX, weekly, 24 months
2: Active Comparator	Drug: placebo and methotrexate placebo: IV, monthly, 12months methotrexate: Tablets, Oral, 20 mg, weekly, 12 months

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of rheumatoid arthritis (RA) <2 years; never received treatment with methotrexate; erosions noted on x-ray.
CRP >= 8.0 mg/L
Rheumatoid factor or anti CCP positive
Additional laboratory requirements

Exclusion Criteria:

Women and men who are not willing to use birth control
Diagnosed with other rheumatic disease
History of cancer within 5 years
Active tuberculosis
Treatment with another investigation drug within 28 days
Active bacterial or viral infection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00122382

Show 91 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM101-023
Study First Received:	July 19, 2005
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00122382 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
Disease Progression
Folate
Rheumatic Diseases
Folinic Acid
Folic Acid Antagonists

Immunosuppressive Agents
Vitamin B9
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 July 06, 2009