Clinical trial NCT02919475: Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: JTE-051
Active Rheumatoid Arthritis
Efficacy
Safety
Tolerability
Rheumatoid Arthritis
Lead sponsor: Akros Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-29
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Subjects Achieving at Least 20% Improvement From Baseline in American College of Rheumatology (ACR) Core Set Measures (ACR20 Response Rate) Compared to Placebo at End-of-treatment (EOT)
timeFrame: Up to 12 Weeks
Secondary outcomes:
measure: Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12
timeFrame: Week 12
measure: Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12
timeFrame: Week 12
measure: Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12
timeFrame: Week 12
measure: Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12
timeFrame: Week 12
measure: Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12
timeFrame: Week 12
measure: Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12
timeFrame: Week 12
measure: Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12
timeFrame: Week 12
measure: Number of Subjects With Treatment-related Adverse Events
timeFrame: Up to 16 Weeks
measure: Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Upland
country: United States
state: California
city: Clearwater
country: United States
state: Florida
city: Hendersonville
country: United States
state: Tennessee
city: La Plata
country: Argentina
state: Buenos Aires
city: San Fernando
country: Argentina
state: Buenos Aires
city: Barrio Norte
country: Argentina
state: Córdoba
city: San Miguel De Tucumán
country: Argentina
state: Tucumán
city: Córdoba
country: Argentina
city: San Juan
country: Argentina
city: Lom
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Sevlievo
country: Bulgaria
city: Sofia
country: Bulgaria
city: Medellín
country: Colombia
state: Antioquia
city: Bogotá
country: Colombia
state: Cundinamarca
city: Cali
country: Colombia
state: Valle Del Cauca
city: Mexicali
country: Mexico
state: B.c.
city: Guadalajara
country: Mexico
state: Jalisco
city: Mexico
country: Mexico
state: Mexico City
city: San Luis Potosí
country: Mexico
state: SLP
city: Mérida
country: Mexico
state: Yucatan
city: Lima
country: Peru
city: Warszawa
country: Poland
state: Masovian
city: Białystok
country: Poland
state: Podlaskie
city: Elbląg
country: Poland
city: Bucharest
country: Romania
city: Iaşi
country: Romania
city: Târgu-Mureş
country: Romania
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kyiv
country: Ukraine
city: Lviv
country: Ukraine
city: Sumy
country: Ukraine
city: Vinnytsia
country: Ukraine
city: Zaporizhzhia
country: Ukraine
Study officials:
affiliation: Akros Pharma Inc.
name: Yoshiro Masuda
role: STUDY_CHAIR
References: