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

NCT02919475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2021-06-14

Study results available
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Summary

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.

Conditions

Interventions

DRUG

JTE-051

Active drug tablets containing JTE-051

DRUG

Placebo

Placebo tablets identical in appearance to the active drug tablets

Sponsors & Collaborators

  • Akros Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Yoshiro Masuda · Akros Pharma Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-14
Primary Completion
2018-06-25
Completion
2018-06-25
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • Colombia
  • Mexico
  • Peru
  • Poland
  • Romania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919475 on ClinicalTrials.gov