NCT00162292

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started Nov 2005

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2005

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

March 2, 2010

Status Verified

August 1, 2008

Enrollment Period

1.9 years

First QC Date

September 9, 2005

Last Update Submit

February 27, 2010

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

    during 28 days of treatment

  • 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

Interventions

BMS-582949 and MethotrexateDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Boling Clinical Trials

Upland, California, 91786, United States

Location

Delray Research Associates

Delray Beach, Florida, 33484, United States

Location

Ocala Rheumatology Research Center

Ocala, Florida, 34474, United States

Location

Phase Iii Clinical Research

Fall River, Massachusetts, 02720, United States

Location

Covance Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Location

Radiant Research San Antonio Northeast

San Antonio, Texas, 78217, United States

Location

Healthcare Discoveries, Inc

San Antonio, Texas, 78229, United States

Location

Local Institution

León, Guanajuato, 37520, Mexico

Location

Local Institution

Metepec, State of Mexico, 52140, Mexico

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

4-(5-(cyclopropylcarbamoyl)-2-methylphenylamino)-5-methyl-N-propylpyrrolo(1,2-f)(1,2,4)triazine-6-carboxamideMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 13, 2005

Study Start

November 1, 2005

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

March 2, 2010

Record last verified: 2008-08

Locations

US(8)ME(2)