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

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)

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: JTE-051

• Study Type: Interventional
• Enrollment (Actual): 260
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Córdoba, Argentina
  • San Juan, Argentina
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina
    • San Fernando, Buenos Aires, Argentina
  • Córdoba
    • Barrio Norte, Córdoba, Argentina
  • Tucumán
    • San Miguel De Tucumán, Tucumán, Argentina
• Bulgaria
  • Lom, Bulgaria
  • Plovdiv, Bulgaria
  • Sevlievo, Bulgaria
  • Sofia, Bulgaria
• Colombia
  • Antioquia
    • Medellín, Antioquia, Colombia
  • Cundinamarca
    • Bogotá, Cundinamarca, Colombia
  • Valle Del Cauca
    • Cali, Valle Del Cauca, Colombia
• Mexico
  • B.c.
    • Mexicali, B.c., Mexico
  • Jalisco
    • Guadalajara, Jalisco, Mexico
  • Mexico City
    • Mexico, Mexico City, Mexico
  • SLP
    • San Luis Potosí, SLP, Mexico
  • Yucatan
    • Mérida, Yucatan, Mexico
• Peru
  • Lima, Peru
• Poland
  • Elbląg, Poland
  • Masovian
    • Warszawa, Masovian, Poland
  • Podlaskie
    • Białystok, Podlaskie, Poland
• Romania
  • Bucharest, Romania
  • Iaşi, Romania
  • Târgu-Mureş, Romania
• Russian Federation
  • Kazan, Russian Federation
  • Moscow, Russian Federation
  • Saint Petersburg, Russian Federation
• Ukraine
  • Kharkiv, Ukraine
  • Kherson, Ukraine
  • Kyiv, Ukraine
  • Lviv, Ukraine
  • Sumy, Ukraine
  • Vinnytsia, Ukraine
  • Zaporizhzhia, Ukraine
• United States
  • Arizona
    • Tucson, Arizona, United States
  • California
    • Upland, California, United States
  • Florida
    • Clearwater, Florida, United States
  • Tennessee
    • Hendersonville, Tennessee, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JTE-051 Dose 1; One dose of study drug by mouth daily for 12 weeks	Drug: JTE-051; Active drug tablets containing JTE-051
Experimental: JTE-051 Dose 2; One dose of study drug by mouth daily for 12 weeks	Drug: JTE-051; Active drug tablets containing JTE-051
Experimental: JTE-051 Dose 3; One dose of study drug by mouth daily for 12 weeks	Drug: JTE-051; Active drug tablets containing JTE-051
Experimental: JTE-051 Dose 4; One dose of study drug by mouth daily for 12 weeks	Drug: JTE-051; Active drug tablets containing JTE-051
Experimental: Placebo; One dose of study drug by mouth daily for 12 weeks	Drug: Placebo; Placebo tablets identical in appearance to the active drug tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Percentage of subjects achieving at least 20% improvement from baseline (ACR20) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 20% improvement from baseline in the 3 of the 5 remaining ACR core set measures at EOT (up to Week 12) compared to placebo. The ACR core set measures are: Tender joint count; Swollen joint count; Subject Assessment of arthritis pain; Subject's Global Assessment of disease activity (SGA); Physician's Global Assessment of disease activity (PGA); Health Assessment Questionnaire Disability Index (HAQ-DI); Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)	Up to 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12	Percentage of subjects achieving at least 20% improvement from baseline (ACR20) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 20% improvement from baseline in the 3 of the 5 remaining ACR core set measures at Week 12 compared to placebo. The ACR core set measures are: Tender joint count; Swollen joint count; Subject Assessment of arthritis pain; Subject's Global Assessment of disease activity (SGA); Physician's Global Assessment of disease activity (PGA); Health Assessment Questionnaire Disability Index (HAQ-DI); Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)	Week 12
Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12	Percentage of subjects achieving at least 50% improvement from baseline (ACR50) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 50% improvement from baseline in the 3 of the 5 remaining ACR core set measures at Week 12 compared to placebo. The ACR core set measures are: Tender joint count; Swollen joint count; Subject Assessment of arthritis pain; Subject's Global Assessment of disease activity (SGA); Physician's Global Assessment of disease activity (PGA); Health Assessment Questionnaire Disability Index (HAQ-DI); Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)	Week 12
Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12	Percentage of subjects achieving at least 70% improvement from baseline (ACR70) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 70% improvement from baseline in the 3 of the 5 remaining ACR core set measures at Week 12 compared to placebo. The ACR core set measures are: Tender joint count; Swollen joint count; Subject Assessment of arthritis pain; Subject's Global Assessment of disease activity (SGA); Physician's Global Assessment of disease activity (PGA); Health Assessment Questionnaire Disability Index (HAQ-DI); Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)	Week 12
Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12	The SDAI Scores indicate how active a patient's rheumatoid arthritis (RA) is currently. The SDAI is the sum of 5 outcome parameters: tender joint score (0 to 28), swollen joint score (0 to 28), Patient's Global Score of disease activity (0 to 10), Physician's Global Score of disease activity (0 to 10) and C-reactive protein (CRP, 0 to 10).General SDAI Score Interpretation is as follows: 0.0 - 3.3 Remission 3.4 - 11.0 Low Activity 11.1 - 26.0 Moderate Activity 26.1 - 86.0 High Activity	Week 12
Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12	The CDAI is a useful clinical composite score for following patients with rheumatoid arthritis (RA). The CDAI is the sum of 4 outcome parameters: tender joint score (0 to 28), swollen joint score (0 to 28), Patient's Global Score of disease activity (0 to 10) and Physician's Global Score of disease activity (0 to 10). The CDAI Score Interpretation is as follows: 0 to 2.8: Remission 2.9 to 10: Low Disease Activity 10.1 to 22: Moderate Disease Activity 22.1 to 76: High Disease Activity	Week 12
Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12	Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consists of composite score of following variables: 28 tender joint count (TJC28) ranging from 0 to 28, 28 swollen joint count (SJC28) ranged from 0 to 28, C-reactive protein (CRP) (milligrams per liter) and subject's global assessment of disease activity (SGA) ranging from 0 (no disease activity) to 10 (extremely active disease). DAS28-CRP was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*SGA+0.96. DAS28-CRP ranged from 0.96-9.4, where lower scores indicated less disease activity and remission is DAS28-CRP <2.6. A decrease in DAS28-CRP indicated an improvement in participant's condition.	Week 12
Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12	The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty [0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do)] in 8 functional area categories: (1) dressing and grooming; (2) arising; (3) eating; (4) walking; (5) hygiene; (6) reaching; (7) gripping; and (8) performing other daily activities. Scores from each functional area category (total 8 categories) were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (severe disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.	Week 12
Number of Subjects With Treatment-related Adverse Events	Subjects in the Safety Population (258, subjects who were randomly assigned to treatment and who received at least one dose of study drug). The number of subjects in the Safety Population is 258 subjects, which is 1 less than the Randomized Population of 259 subjects, since 1 randomized subject did not receive any study drug.	Up to 16 Weeks
Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12		Week 12

Collaborators and Investigators

• Sponsor: Akros Pharma Inc.
• Investigators: Study Chair: Yoshiro Masuda, Akros Pharma Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2016
• Primary Completion (Actual): June 25, 2018
• Study Completion (Actual): June 25, 2018

Study Registration Dates

• First Submitted: September 27, 2016
• First Submitted That Met QC Criteria: September 28, 2016
• First Posted (Estimate): September 29, 2016

Study Record Updates

• Last Update Posted (Actual): June 14, 2021
• Last Update Submitted That Met QC Criteria: June 11, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Rheumatoid Arthritis; Tolerability; Active Rheumatoid Arthritis; JTE-051
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: AE051-G-13-003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes