Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:8/18/2018
Start Date:September 14, 2016
End Date:June 25, 2018

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A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA)

This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of
JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are
receiving background non-biologic disease-modifying anti-rheumatic drug therapy.


Inclusion Criteria:

- A diagnosis of RA prior to the Screening Visit.

- Active disease despite ongoing therapy with up to two non-biologic disease-modifying
anti-rheumatic drugs, including methotrexate at both the Screening and Baseline
Visits.

- Screening hs-CRP ≥1.2 x upper limit of normal (ULN).

Exclusion Criteria:

- Prior/current exposure to biologic and/or kinase inhibitor therapy.

- Known history or presence of polyneuropathy of any cause and no presence of clinically
active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.

- Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or
hepatitis C (HCV) virus at the Screening Visit.

- Positive drug of abuse and alcohol test results.

- History of a clinically-significant infection that required oral antimicrobial or
antiviral therapy within 8 weeks prior to Day 1.
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