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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-582949 and Methotrexate
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Desert Medical Advances
  • Boling Clinical Trials
  • Delray Research Associates
  • Ocala Rheumatology Research Center
  • Phase Iii Clinical Research
  • Covance Clinical Research Unit Inc.
  • Radiant Research San Antonio Northeast
  • Healthcare Discoveries, Inc
  • Local Institution
  • Local Institution

Outcomes

Primary Outcome Measures

To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state

Secondary Outcome Measures

To evaluate the PK of BMS-582949 in clinically stable RA subjects on stable doses of MTX and concomitant BMS-582949
To explore DAS28, ESR, RF and CRP of clinically stable doses of MTX and concomitant BMS-582949 compared to MTX alone
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

Full Information

First Posted
September 9, 2005
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00162292
Brief Title
Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
Official Title
Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
BMS-582949 and Methotrexate
Primary Outcome Measure Information:
Title
To evaluate safety and tolerability of BMS-582949 in subjects with active rheumatoid arthritis receiving concomitant MTX at steady state
Time Frame
during 28 doses of treatment
Secondary Outcome Measure Information:
Title
To evaluate the PK of BMS-582949 in clinically stable RA subjects on stable doses of MTX and concomitant BMS-582949
Title
To explore DAS28, ESR, RF and CRP of clinically stable doses of MTX and concomitant BMS-582949 compared to MTX alone
Time Frame
during 28 days of treatment
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Desert Medical Advances
City
Palm Desert
State/Province
California
ZIP/Postal Code
92260
Country
United States
Facility Name
Boling Clinical Trials
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Delray Research Associates
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Ocala Rheumatology Research Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Phase Iii Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Covance Clinical Research Unit Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Facility Name
Radiant Research San Antonio Northeast
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Healthcare Discoveries, Inc
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Local Institution
City
Metepec
State/Province
Estado De Mexico
ZIP/Postal Code
52140
Country
Mexico
Facility Name
Local Institution
City
Leon
State/Province
Guanajuato
ZIP/Postal Code
37520
Country
Mexico

12. IPD Sharing Statement

Learn more about this trial

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

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