Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
NCT ID: NCT02919475
Last Updated: 2021-06-14
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
260 participants
INTERVENTIONAL
2016-09-14
2018-06-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice
NCT01474291
Dose-Escalating Multiple Dose Study of PD-0360324 in Combination With Methotrexate in Patients With Rheumatoid Arthritis
NCT00550355
A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
NCT00550043
A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis
NCT04985812
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
NCT02969044
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
JTE-051 Dose 1
One dose of study drug by mouth daily for 12 weeks
JTE-051
Active drug tablets containing JTE-051
JTE-051 Dose 2
One dose of study drug by mouth daily for 12 weeks
JTE-051
Active drug tablets containing JTE-051
JTE-051 Dose 3
One dose of study drug by mouth daily for 12 weeks
JTE-051
Active drug tablets containing JTE-051
JTE-051 Dose 4
One dose of study drug by mouth daily for 12 weeks
JTE-051
Active drug tablets containing JTE-051
Placebo
One dose of study drug by mouth daily for 12 weeks
Placebo
Placebo tablets identical in appearance to the active drug tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
JTE-051
Active drug tablets containing JTE-051
Placebo
Placebo tablets identical in appearance to the active drug tablets
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Akros Pharma Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yoshiro Masuda
Role: STUDY_CHAIR
Akros Pharma Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tucson, Arizona, United States
Upland, California, United States
Clearwater, Florida, United States
Hendersonville, Tennessee, United States
La Plata, Buenos Aires, Argentina
San Fernando, Buenos Aires, Argentina
Barrio Norte, Córdoba Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina
Córdoba, , Argentina
San Juan, , Argentina
Lom, , Bulgaria
Plovdiv, , Bulgaria
Sevlievo, , Bulgaria
Sofia, , Bulgaria
Medellín, Antioquia, Colombia
Bogotá, Cundinamarca, Colombia
Cali, Valle del Cauca Department, Colombia
Mexicali, B.C., Mexico
Guadalajara, Jalisco, Mexico
Mexico City, Mexico City, Mexico
San Luis Potosí City, San Luis Potosí, Mexico
Mérida, Yucatán, Mexico
Lima, , Peru
Warsaw, Masovian Voivodeship, Poland
Bialystok, Podlaskie Voivodeship, Poland
Elblag, , Poland
Bucharest, , Romania
Iași, , Romania
Târgu Mureş, , Romania
Kazan', , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Kharkiv, , Ukraine
Kherson, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Sumy, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AE051-G-13-003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.