PoC in Rheumatoid Arthritis With Methotrexate - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00605735

Purpose

The purpose of this study is to find out if 300 mg of BMS-582949 given once daily will be more effective than placebo after 12 weeks of treatment in subjects with rheumatoid arthritis who are also taking methotrexate

Condition	Intervention	Phase
Rheumatoid Arthritis, NOS	Drug: BMS-582949 Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Parallel Group, Double-Blind, Placebo-Controlled Study to Evaluate the Clinical Efficacy and Safety of BMS-582949 Given Orally to Subjects With Rheumatoid Arthritis Having an Inadequate Response to Methotrexate

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The primary endpoint is the proportion of subjects achieving an ACR 20 at Week 12 [ Time Frame: at Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of subjects achieving an ACR 20 [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
Proportion of subjects schieving and ACR 50 [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
Proportion of subjects schieving and ACR 70 [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
Percent change from baseline to each scheduled visit in DAS28 score [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
Percent change from baseline to each scheduled visit in ACR scores [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
Proportion of subjects schieving a 20% change in assessment of pain, disease activity and fatigue [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]
Percent change from baseline to each scheduled visit in HAQ score [ Time Frame: at each scheduled visit ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: BMS-582949 Tablets, Oral, 300 mg, once daily, 12 weeks
P1: Placebo Comparator	Drug: Placebo Tablets, Oral, placebo, once daily, 12 weeks

Eligibility

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

Criteria

Inclusion Criteria:

Must have a diagnosis of RA for at least 6 months
Must be taking methotrexate for at least 3 months & on a stable dose of 7.5-30 mg weekly) for 4 weeks before dosing with study medication
Must have at least 6 swollen and at least 8 tender joints
CRP above upper limit of normal or ESR > 28 mm/hr
Must wash-out (stop taking) other immunosuppressant medications to treat RA (except for methotrexate) before dosing with study medication

Exclusion Criteria:

Any infection including TB, HIV, Hepatitis B or C
Recent infection requiring antibiotics within 4 weeks
History of gastrointestinal disease (such as GERD, gastrointestinal ulcers, heartburn) requiring medical or surgical treatment within 3 months
Chronic use of proton pump inhibitors (such as Losec, Prilosec, Prevacid, Nexium), H2 blockers (such as Tagamet, Pepcid, Zantac, Axid) or antacids (such as Mylanta, Maalox)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605735

Show 24 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:	IM119-015
Study First Received:	January 18, 2008
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00605735 History of Changes
Health Authority:	United States: Food and Drug Administration; France: Afssaps - French Health Products Safety Agency; Spain: Agencia Espanola del Medicamento y Productos Sanitarios; Korea: Food and Drug Administration; Mexico: Federal Commission for Sanitary Risks Protection; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Czech Republic: State Institute for Drug Control; Taiwan: Department of Health

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
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
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 10, 2009