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BMS-817399

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Oct 12, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment123

FDA Designations

No designations recorded

Clinical trial landscape

BMS-817399 · 1 trial · 1 indication

Phase 2 1
NCT01404585Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid ArthritisRheumatoid Arthritis
COMPLETED123 Analytics
PHASE2COMPLETED
Proof-of-Concept Study With BMS-817399 to Treat Moderate to Severe Rheumatoid Arthritis
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Disease Activity Score using 28 joint count and C Reactive Protein (DAS28-CRP) change from baseline of BMS-817399 versus placebo
Baseline and at 12 weeks

Secondary Endpoints

Safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiogram, physical examinations, and clinical laboratory tests
16 weeks
Proportion of subjects achieving 20% American College of Rheumatology (ACR) response in each treatment group
Day 15
Proportion of subjects achieving 20% ACR response in each treatment group
Day 29
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1: PlaceboPLACEBO_COMPARATOR -
Arm 2: BMS-817399 (200 mg)EXPERIMENTAL -
Arm 3: BMS-817399 (400 mg)EXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGTablets, Oral, 0 mg, twice daily, 12 weeks
BMS-817399DRUGTablets, Oral, 200 mg, twice daily, 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusion Criteria: * Male or female subjects, 18 years of age or older, with rheumatoid arthritis (RA) for at least 6 months prior to screening * Subjects must have a tender joint count of at least 6 (28 joint count), swollen joint count of at least 6 (28 joint count) at screening. All subjects mu...

Countries:United StatesArgentinaMexicoRussiaSouth AfricaSouth KoreaSpain
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Frequently asked questions about BMS-817399

What is BMS-817399 used for?

BMS-817399 is an investigational small molecule being developed for the treatment of moderate to severe rheumatoid arthritis. It is currently in Phase 2 clinical development and has not been approved by the FDA.

Who makes BMS-817399?

BMS-817399 is being developed by Bristol-Myers Squibb Company, which is publicly traded under the ticker symbol BMY on the New York Stock Exchange.

What phase is BMS-817399 in?

BMS-817399 is in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval for any use.

What clinical trials is BMS-817399 in?

BMS-817399 has one completed Phase 2 clinical trial, identified as NCT01404585. This was a proof-of-concept study in patients with moderate to severe rheumatoid arthritis, enrolling 123 participants across multiple countries.

Was the BMS-817399 trial randomized and controlled?

Yes, the Phase 2 trial of BMS-817399 was a randomized, double-blind, placebo-controlled study. It enrolled 123 patients with moderate to severe rheumatoid arthritis and was conducted in the United States, Argentina, Mexico, Russia, South Africa, South Korea, and Spain.