A Phase IIIb Study of BMS-188667 in Subjects 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:	NCT00420199

Purpose

The only trial in subjects with active Rheumatoid Arthritis, Methotrexate inadequate responders, in which gadolinium-enhanced Magnetic Resonance Imaging, Bone Mineral Density and biochemical markers of bone, cartilage and synovial tissue metabolism are used to evaluate early effects (4 months) of Abatacept on inflammation/structural damage. Study will provide valuable mechanism of action information on how Abatacept exerts its effects (including on bone) through new techniques

Condition	Intervention	Phase
Rheumatoid Arthritis, NOS	Drug: Abatacept Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Phase IIIB Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Assess Short-term Changes in Synovitis and Structural Damage Outcomes in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate, Treated With Abatacept Versus Placebo on a Background Therapy With Methotrexate

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Rheumatoid Arthritis

Drug Information available for: Methotrexate Abatacept

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Change in wrist Synovitis evaluated by gadolinium-enhanced Magnetic Resonance Imaging, using OMERACT 6 score [ Time Frame: at 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess change in bone lesions (i.e. bone edema, bone erosions), of hands (measured by gadolinium-enhanced Magnetic Resonance Imaging and using the OMERACT 6 RA MRI) [ Time Frame: At 4 months (end of Double-Blind period) and 1 Year (end of Open-Label period) ] [ Designated as safety issue: No ]
Assess changes in biochemical markers of bone, cartilage and synovial tissue metabolism [ Time Frame: At days, 15, 29 and Months 4, 6, 9, 12 ] [ Designated as safety issue: No ]
Assess safety and tolerability in both treatment arms [ Time Frame: over 4 months (end of Double-Blind period) and 1 year of treatment (end of Open-label period) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	50
Study Start Date:	May 2007
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Abatacept Vials (250 mg/vial), IV, 10 mg/kg, monthly infusion , 12 months of treatment
2: Placebo Comparator	Drug: placebo IV bags, IV, 0 mg, monthly infusion, 12 months of treatment

Eligibility

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

Criteria

Inclusion Criteria:

Disease activity as defined by a DAS28-CRP >3.2 OR > 6 swollen and ≥6 tender joints and CRP greater than the upper limit of normal
At least 1 erosion in hands/wrists or anti-CCP+ or rheumatoid factors positive
Clinically detectable synovitis of at least one wrist/ankle at screening and baseline
Subjects must have been treated with Methotrexate, on a weekly dose of at least 15 mg or a maximum tolerated dose (i.e. 10 mg weekly) for at least 3 months before screening. Dose of MTX must be stable for at least 28 days prior to the first study dose (baseline i.e. Day 1)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00420199

Locations

Belgium
Local Institution
Bruxelles, Belgium, 1200
Local Institution
Yvoir, Belgium, 5530
Germany
Local Institution
Berlin, Germany, BE-10117
Local Institution
Berlin, Germany, 14059
Netherlands
Local Institution
Amsterdam, Netherlands, 1105 AZ
Spain
Local Institution
Barcelona, Spain, 08036
Local Institution
Barcelona, Spain, 08907
Sweden
Local Institution
Stockholm, Sweden, 171 76
United Kingdom, North Yorkshire
Local Institution
Leeds, North Yorkshire, United Kingdom, LS7 4SA

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: http://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:	IM101-119, Eudract: 2006-003768-67
Study First Received:	January 8, 2007
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00420199 History of Changes
Health Authority:	Sweden: Lakemedelsverket Medical Products Agency

Study placed in the following topic categories:

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

Vitamin B9
Folic Acid
Abatacept
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Synovitis
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 September 09, 2009