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RWJ-445380

Phase 2

Rheumatoid Arthritis | Small molecule | Immunology |Johnson & Johnson|Last Updated: May 21, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment259

FDA Designations

No designations recorded

Clinical trial landscape

RWJ-445380 · 1 trial · 1 indication

Phase 2 1
NCT00425321Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid Arthritis
COMPLETED259 Analytics
PHASE2COMPLETED
Safety and Effectiveness Study of RWJ-445380 Cathepsin-S Inhibitor in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Rheumatoid ArthritisUnlock trial analytics

Study Endpoints

Primary Endpoints

Evaluate the safety of RWJ-445380 for up to 12 weeks; assessing adverse events, vital signs, laboratory and physical exam and ECGs in patients with rheumatoid arthritis
up to 12 weeks

Secondary Endpoints

Explore effectiveness of drug through accepted arthritis clinical measures and biomarkers
12 weeks, Explore effectiveness of drug through accepted clinical measures and biomarkers
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
RWJ-445380 100 mgEXPERIMENTAL -
RWJ-445380 200 mgEXPERIMENTAL -
RWJ-445380 300 mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
RWJ-445380 100 mgDRUGRWJ-445380 100 mg once daily for up to 12 weeks
RWJ-445380 200 mgDRUGRWJ-445380 200 mg once daily for up to 12 weeks
RWJ-445380 300 mgDRUGRWJ-445380 300 mg once daily for up to 12 weeks
PlaceboDRUGPlacebo once daily for up to 12 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites42

Inclusion Criteria: * Patients diagnosed with rheumatoid arthritis for at least 6 months with at least 8 tender and 8 swollen joints * methotrexate treatment for 6 months * at least 10mg/wk and stable dose for at least 8 weeks * negative TB screening Exclusion Criteria: * Use of other disease-mod...

Countries:United StatesArgentinaBrazilCzechiaGermanyMexicoPoland
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Frequently asked questions about RWJ-445380

What is RWJ-445380 used for?

RWJ-445380 is an investigational small molecule being studied for the treatment of rheumatoid arthritis. It was evaluated in patients with active rheumatoid arthritis who were already receiving methotrexate therapy. The drug is not approved and remains in clinical development.

What does RWJ-445380 target?

RWJ-445380 is a cathepsin-S inhibitor. Cathepsin-S is an enzyme involved in antigen presentation and immune response, and inhibiting it is being studied as a potential approach to treat rheumatoid arthritis.

Who makes RWJ-445380?

RWJ-445380 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ.

What phase is RWJ-445380 in?

RWJ-445380 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is RWJ-445380 in?

RWJ-445380 has been studied in one completed Phase 2 trial, NCT00425321, which enrolled 259 participants with active rheumatoid arthritis despite methotrexate therapy. The trial was randomized, double-blind, and placebo-controlled, and took place in the United States, Argentina, Brazil, Czechia, Germany, Mexico, and Poland.