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JNJ-40346527

Phase 2

Arthritis, Rheumatoid | Small molecule | Immunology |Johnson & Johnson|Last Updated: Apr 8, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment96

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-40346527 · 1 trial · 1 indication

Phase 2 1
NCT01597739A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug TherapyArthritis, Rheumatoid
COMPLETED96 Analytics
PHASE2COMPLETED
A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy
Arthritis, RheumatoidUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in the Disease Activity Score (DAS28), using C-reactive protein (CRP)
Week 12

The DAS28 is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and an overall assessment of disease activity.

Secondary Endpoints

ACR 20 response
Week 12
DAS28 (using CRP) response
Week 12
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
JNJ-40346527EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
JNJ-40346527DRUGType=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.
PlaceboDRUGForm=capsule; route=oral use; twice daily.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites32

Inclusion Criteria: * Diagnosis of rheumatoid arthritis (RA) for at least 6 months prior to screening * Have been positive for, or are positive at screening for, either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum * Have active RA with at least 6 swollen ...

Countries:ArgentinaBulgariaChileCzechiaHungaryPolandRussiaSingaporeSouth KoreaUkraine
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Frequently asked questions about JNJ-40346527

What is JNJ-40346527 used for?

JNJ-40346527 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It is intended for patients with active rheumatoid arthritis despite disease-modifying antirheumatic drug therapy. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does JNJ-40346527 target?

JNJ-40346527 is a small molecule developed by Johnson & Johnson for rheumatoid arthritis. The specific molecular target of JNJ-40346527 is not disclosed in the available information. It is being evaluated in a Phase 2 clinical trial for its efficacy and safety in patients with active rheumatoid arthritis.

Who makes JNJ-40346527?

JNJ-40346527 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is currently in Phase 2 clinical development for the treatment of rheumatoid arthritis.

What phase is JNJ-40346527 in?

JNJ-40346527 is in Phase 2 clinical development. It is an investigational drug for rheumatoid arthritis and has not been approved by the FDA or any other regulatory agency. The drug is being studied in patients with active rheumatoid arthritis despite disease-modifying antirheumatic drug therapy.

What clinical trials is JNJ-40346527 in?

JNJ-40346527 has been studied in one completed Phase 2 clinical trial, identified as NCT01597739. This randomized, double-blind, placebo-controlled trial enrolled 96 patients with active rheumatoid arthritis despite disease-modifying antirheumatic drug therapy. The trial was conducted across multiple countries including Argentina, Bulgaria, Chile, Czechia, Hungary, Poland, Russia, Singapore, South Korea, and Ukraine.

Is JNJ-40346527 the same as any other drug?

JNJ-40346527 is the sole name provided for this investigational drug. No alternative names or aliases have been identified in the available information. The drug is being developed by Johnson & Johnson for the treatment of rheumatoid arthritis and is currently in Phase 2 clinical trials.