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

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate

U.S. FDA Resources

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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Measure % of subjects achieving ACR20 response (20% improvement in RA symptoms using the American College of Rheumatology measurements), and determine the difference in ACR20 response between each dose group (300 mg once daily) compared to placebo [ Time Frame: following 12 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the proportion of subjects who achieve an ACR50 (50% improvement in RA symptoms), ACR70 (70% improvement in RA symptoms), ACR-N (overall improvement) and DAS28 (Disease Activity measurement) response [ Time Frame: at each study visit over 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2009
Estimated Primary Completion Date:	October 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

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 37 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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:	IM119-015
Study First Received:	January 18, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00605735
Health Authority:	United States: Food and Drug Administration; France: Agence Francaise de Securite Sanitaire des Produits de Sante; Spain: Agencia Espanola del Medicamento y Productos Sanitarios; Korea: Korean Food and Drug Administration; Mexico: Comision Federal para la proteccion contra riesgos sanitarios; Brazil: Agencia Nacional de Vigilancia Sanitaria; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Czech Republic: State Institute of Drug Control; Taiwan: Department of Health

Study placed in the following topic categories:

Folic Acid
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 January 14, 2009