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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT02919475

Run by

Akros Pharma Inc.

People needed

260

Starts

2016-09-14

Expected to finish

2018-06-25

Last updated by the study team

2021-06-14

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Upland, California, United States
• Study site — Clearwater, Florida, United States
• Study site — Hendersonville, Tennessee, United States
• Study site — La Plata, Buenos Aires, Argentina
• Study site — San Fernando, Buenos Aires, Argentina
• Study site — Barrio Norte, Córdoba Province, Argentina
• Study site — San Miguel de Tucumán, Tucumán Province, Argentina
• Study site — Córdoba, Argentina
• Study site — San Juan, Argentina
• Study site — Lom, Bulgaria
• Study site — Plovdiv, Bulgaria
• Study site — Sevlievo, Bulgaria
• Study site — Sofia, Bulgaria
• Study site — Medellín, Antioquia, Colombia
• Study site — Bogotá, Cundinamarca, Colombia
• Study site — Cali, Valle del Cauca Department, Colombia
• Study site — Mexicali, B.C., Mexico
• Study site — Guadalajara, Jalisco, Mexico
• Study site — Mexico City, Mexico City, Mexico
• Study site — San Luis Potosí City, San Luis Potosí, Mexico
• Study site — Mérida, Yucatán, Mexico
• Study site — Lima, Peru
• Study site — Warsaw, Masovian Voivodeship, Poland
• Study site — Bialystok, Podlaskie Voivodeship, Poland

Full record on ClinicalTrials.gov

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