Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGBMS-582949 and Methotrexate
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Mexico, United States
Outcome results
None listed