Back to resultsStudy to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis (MOVE-RA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JTE-051
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring JTE-051, Active Rheumatoid Arthritis, Efficacy, Safety, Tolerability, Rheumatoid Arthritis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
JTE-051 Dose 1
JTE-051 Dose 2
JTE-051 Dose 3
JTE-051 Dose 4
Placebo
Arm Description
One dose of study drug by mouth daily for 12 weeks
One dose of study drug by mouth daily for 12 weeks
One dose of study drug by mouth daily for 12 weeks
One dose of study drug by mouth daily for 12 weeks
One dose of study drug by mouth daily for 12 weeks
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
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)
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
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
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.
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.
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.
Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02919475
Brief Title
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
Acronym
MOVE-RA
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
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 14, 2016 (Actual)
Primary Completion Date
June 25, 2018 (Actual)
Study Completion Date
June 25, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akros Pharma Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
JTE-051, Active Rheumatoid Arthritis, Efficacy, Safety, Tolerability, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JTE-051 Dose 1
Arm Type
Experimental
Arm Description
One dose of study drug by mouth daily for 12 weeks
Arm Title
JTE-051 Dose 2
Arm Type
Experimental
Arm Description
One dose of study drug by mouth daily for 12 weeks
Arm Title
JTE-051 Dose 3
Arm Type
Experimental
Arm Description
One dose of study drug by mouth daily for 12 weeks
Arm Title
JTE-051 Dose 4
Arm Type
Experimental
Arm Description
One dose of study drug by mouth daily for 12 weeks
Arm Title
Placebo
Arm Type
Experimental
Arm Description
One dose of study drug by mouth daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
JTE-051
Intervention Description
Active drug tablets containing JTE-051
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo tablets identical in appearance to the active drug tablets
Primary Outcome Measure Information:
Title
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)
Description
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)
Time Frame
Up to 12 Weeks
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12
Description
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)
Time Frame
Week 12
Title
Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12
Description
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)
Time Frame
Week 12
Title
Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12
Description
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)
Time Frame
Week 12
Title
Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12
Description
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
Time Frame
Week 12
Title
Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12
Description
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
Time Frame
Week 12
Title
Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12
Description
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.
Time Frame
Week 12
Title
Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12
Description
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.
Time Frame
Week 12
Title
Number of Subjects With Treatment-related Adverse Events
Description
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.
Time Frame
Up to 16 Weeks
Title
Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiro Masuda
Organizational Affiliation
Akros Pharma Inc.
Official's Role
Study Chair
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Upland
State/Province
California
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Hendersonville
State/Province
Tennessee
Country
United States
City
La Plata
State/Province
Buenos Aires
Country
Argentina
City
San Fernando
State/Province
Buenos Aires
Country
Argentina
City
Barrio Norte
State/Province
Córdoba
Country
Argentina
City
San Miguel De Tucumán
State/Province
Tucumán
Country
Argentina
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
State/Province
Antioquia
Country
Colombia
City
Bogotá
State/Province
Cundinamarca
Country
Colombia
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
City
Mexicali
State/Province
B.c.
Country
Mexico
City
Guadalajara
State/Province
Jalisco
Country
Mexico
City
Mexico
State/Province
Mexico City
Country
Mexico
City
San Luis Potosí
State/Province
SLP
Country
Mexico
City
Mérida
State/Province
Yucatan
Country
Mexico
City
Lima
Country
Peru
City
Warszawa
State/Province
Masovian
Country
Poland
City
Białystok
State/Province
Podlaskie
Country
Poland
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
12. IPD Sharing Statement
Learn more about this trial
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
We'll reach out to this number within 24 hrs