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

Akros Pharma

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: JTE-051

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02919475

AE051-G-13-003

Details and patient eligibility

About

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.

Enrollment

260 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

260 participants in 5 patient groups

JTE-051 Dose 1

Experimental group

Description: