Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background

Rheumatoid Arthritis Clinical Trial

Official title:

Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162292
• Other study ID #: IM119-010
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: February 27, 2010
• Start date: November 2005
• Est. completion date: October 2007

Study information

• Verified date: August 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn if it is safe for rheumatoid arthritis patients to take BMS-582949 along with methotrexate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years

• Diagnosis of RA for =6 months

• Swollen or tender joint or ESR >ULN. Subject must be on stable doses of MTX

• Women of Childbearing Potential

Exclusion Criteria:

• Serum transaminase levels >ULN

• CK>ULN

• Cannot have taken Orencia or Remicade within 8 weeks of baseline, Humira or Enbrel within 4 weeks of baseline

• Use of H2 blockers or Proton Pump inhibitors while on study

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• BMS-582949 and Methotrexate

Locations

Country	Name	City	State
Mexico	Local Institution	Leon	Guanajuato
Mexico	Local Institution	Metepec	Estado De Mexico
United States	Covance Clinical Research Unit Inc.	Dallas	Texas
United States	Delray Research Associates	Delray Beach	Florida
United States	Phase Iii Clinical Research	Fall River	Massachusetts
United States	Ocala Rheumatology Research Center	Ocala	Florida
United States	Desert Medical Advances	Palm Desert	California
United States	Healthcare Discoveries, Inc	San Antonio	Texas
United States	Radiant Research San Antonio Northeast	San Antonio	Texas
United States	Boling Clinical Trials	Upland	California

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state		during 28 doses of treatment
Secondary	To evaluate the PK of BMS-582949 in clinically stable RA subjects on stable doses of MTX and concomitant BMS-582949
Secondary	To explore DAS28, ESR, RF and CRP of clinically stable doses of MTX and concomitant BMS-582949 compared to MTX alone		during 28 days of treatment
Secondary	To evaluate PK of MTX in stable RA subjects in the absence and presence of BMS-582949 for subjects enrolled prior to approval of amendment 2

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm