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BMS-582949 and Methotrexate

Phase 1

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Mar 2, 2010

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

BMS-582949 and Methotrexate · 1 trial · 1 indication

Phase 1 1
NCT00162292Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate BackgroundRheumatoid Arthritis
COMPLETED33 Analytics
PHASE1COMPLETED
Multiple Ascending Dose Study of BMS-582949 in Patients With Stable Rheumatoid Arthritis on the Methotrexate Background
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
BMS-582949 and MethotrexateDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites10

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 w...

Countries:United StatesMexico
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Frequently asked questions about BMS-582949 and Methotrexate

What is BMS-582949 used for?

BMS-582949 is an investigational small molecule being studied for the treatment of psoriasis, rheumatoid arthritis, and vascular diseases such as atherosclerosis. It has been evaluated in clinical trials for these conditions, though it is not approved and remains in clinical development.

What does BMS-582949 target?

BMS-582949 is a p38 kinase inhibitor, as indicated in a clinical trial title for treating atherosclerosis. It works by inhibiting p38 kinase, an enzyme involved in inflammatory signaling pathways relevant to the diseases under study.

Who makes BMS-582949?

BMS-582949 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored clinical trials of the drug across multiple indications.

What phase is BMS-582949 in?

BMS-582949 has completed Phase 2 clinical trials for psoriasis, rheumatoid arthritis, and vascular diseases. It is an investigational drug and has not been approved by regulatory authorities, as it remains in clinical development.

What clinical trials is BMS-582949 in?

BMS-582949 has been studied in several completed trials. These include NCT00162292, a Phase 1 multiple ascending dose study in rheumatoid arthritis; NCT00399906, a Phase 2 trial in plaque psoriasis; NCT00570752, a Phase 2 study in atherosclerosis; and NCT00605735, a Phase 2 proof-of-concept trial in rheumatoid arthritis.

Is BMS-582949 the same as any other drug?

BMS-582949 is the sole name provided for this investigational compound. No alternative names have been identified in the available information, so it is not known to be the same as any other marketed or investigational drug.