Methotrexate-Inadequate Response Study - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00559585

Purpose

The purpose of this study is to determine, if a weekly subcutaneous (SC) doses of abatacept will yield comparable clinical efficacy to monthly intravenous (IV) doses of abatacept in subjects with rheumatoid arthritis having an inadequate response to their current methotrexate (MTX) therapy

Condition	Intervention	Phase
Rheumatoid Arthritis (RA)	Drug: Abatacept subcutaneous + placebo IV Drug: Abatacept IV + placebo subcutaneous	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, Efficacy Study
Official Title:	A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

ACR 20 [ Time Frame: at Visit Day 169 (end of short term) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ACR 50 and ACR 70 [ Time Frame: at Visit Day 169 (end of short term) ] [ Designated as safety issue: No ]
pharmacokinetics, immunogenicity, change in HAQ (Health Assessment Questionnaire) responses [ Time Frame: at Day 169 ] [ Designated as safety issue: No ]

Estimated Enrollment:	1650
Study Start Date:	January 2008
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator double-dummy design	Drug: Abatacept subcutaneous + placebo IV solution in pre-filled syringes, subcutaneous injection (+ IV infusion), 125 mg/kg in the subcutaneous injection, weekly injections, 169 days in short term; long term is open
B: Active Comparator	Drug: Abatacept IV + placebo subcutaneous solution for IV infusion, IV infusion + subcutaneous injection, monthly IV infusions are dosed weight-tiered: 500mg (for body weight up to 60 kg) 750 mg (body weight between 61 and 100 kg) 1g (body weight above 100 kg)infusions

Eligibility

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

Criteria

Inclusion Criteria:

Subjects who are considered methotrexate inadequate responders
10 or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)

Exclusion Criteria:

Subjects who failed one or multiple anti-TNF therapies
Subjects who meet diagnostic criteria for any other rheumatic disease (eg, lupus erythematous)
Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
Subjects with severe chronic or recurrent bacterial infections
Subjects who have received treatment with rituximab

Anti-TNF failure substudy at selected sites: The same criteria apply except for the exclusion of subjects who failed an anti-TNF therapy before

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559585

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 242 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: 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:	IM101-174, EUDRACT # 2007-005434-37
Study First Received:	November 15, 2007
Last Updated:	May 6, 2009
ClinicalTrials.gov Identifier:	NCT00559585 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