Rheumatoid ArthritisPhase 2MOVE-RANCT02919475
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
A Phase 2 study testing JTE-051 in people with Rheumatoid Arthritis, run by Shionogi Inc. at 39 sites in 10 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- JTE-051
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 39 sitesin 10 countries
- Study dates
- 14 Sep 2016to 25 Jun 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
39 sites in 10 countries.
39 sites in 10 countries
Ukraine7 sites
Study site
Kharkiv
Study site
Kherson
Study site
Kyiv
Study site
Lviv
Study site
Sumy
Study site
Vinnytsia
Study site
Zaporizhzhya
Argentina6 sites
Study site
Barrio Norte, Córdoba Province
Study site
Córdoba
Study site
La Plata, Buenos Aires
Study site
San Fernando, Buenos Aires
Study site
San Juan
Study site
San Miguel de Tucumán, Tucumán Province
Mexico5 sites
Study site
Guadalajara, Jalisco
Study site
Mérida, Yucatán
Study site
Mexicali, B.C.
Study site
Mexico City, Mexico City
Study site
San Luis Potosí City, San Luis Potosí
United States4 sites
Study site
Clearwater, Florida
Study site
Hendersonville, Tennessee
Study site
Tucson, Arizona
Study site
Upland, California
Bulgaria4 sites
Study site
Lom
Study site
Plovdiv
Study site
Sevlievo
Study site
Sofia
Colombia3 sites
Study site
Bogotá, Cundinamarca
Study site
Cali, Valle del Cauca Department
Study site
Medellín, Antioquia
Poland3 sites
Study site
Bialystok, Podlaskie Voivodeship
Study site
Elblag
Study site
Warsaw, Masovian Voivodeship
About this study
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)
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
- Rheumatoid Arthritis
- Being tested
- JTE-051, Placebo
- Keywords
- JTE-051, Active Rheumatoid Arthritis, Efficacy, Safety, Tolerability, Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JTE-051Drug
Active drug tablets containing JTE-051
PlaceboDrug
Placebo tablets identical in appearance to the active drug tablets
| Study group | Role | What they receive |
|---|---|---|
| JTE-051 Dose 1 | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: JTE-051 |
| JTE-051 Dose 2 | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: JTE-051 |
| JTE-051 Dose 3 | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: JTE-051 |
| JTE-051 Dose 4 | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: JTE-051 |
| Placebo | Experimental | One dose of study drug by mouth daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 12 Weeks
Secondary outcomes (9)
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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 16 Weeks
Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study start14 Sep 2016
- Primary completion25 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shionogi Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yoshiro Masuda, Study chair, Shionogi Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919475
- Sponsor's protocol ID
- AE051-G-13-003
- Acronym
- MOVE-RA
- Status last verified
- Jun 2021
- First submitted
- 27 Sep 2016
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02919475
- Acronym / sponsor ID
- MOVE-RA / AE051-G-13-003
- Conditions
- Rheumatoid Arthritis
- Keywords
- JTE-051, Active Rheumatoid Arthritis, Efficacy, Safety, Tolerability, Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Shionogi Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Sep 2016 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 29 Sep 2016 (estimated)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| JTE-051 Dose 1 | Experimental | Drug: JTE-051One dose of study drug by mouth daily for 12 weeks |
| JTE-051 Dose 2 | Experimental | Drug: JTE-051One dose of study drug by mouth daily for 12 weeks |
| JTE-051 Dose 3 | Experimental | Drug: JTE-051One dose of study drug by mouth daily for 12 weeks |
| JTE-051 Dose 4 | Experimental | Drug: JTE-051One dose of study drug by mouth daily for 12 weeks |
| Placebo | Experimental | Drug: PlaceboOne dose of study drug by mouth daily for 12 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JTE-051Active drug tablets containing JTE-051 | Drug | JTE-051 Dose 1, JTE-051 Dose 2, JTE-051 Dose 3, JTE-051 Dose 4 |
| PlaceboPlacebo tablets identical in appearance to the active drug tablets | Drug | Placebo |
Primary outcome
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)
Time frame: Up to 12 Weeks
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: 1. Tender joint count 2. Swollen joint count 3. Subject Assessment of arthritis pain 4. Subject's Global Assessment of disease activity (SGA) 5. Physician's Global Assessment of disease activity (PGA) 6. Health Assessment Questionnaire Disability Index (HAQ-DI) 7. Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)
9 secondary outcomes
Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12
Time frame: Week 12
Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12
Time frame: Week 12
Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12
Time frame: Week 12
Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12
Time frame: Week 12
Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12
Time frame: Week 12
Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12
Time frame: Week 12
Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12
Time frame: Week 12
Number of Subjects With Treatment-related Adverse Events
Time frame: Up to 16 Weeks
Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12
Time frame: Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoshiro Masuda study chair
Shionogi Inc.
39 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JTE-051 in people with Rheumatoid Arthritis, run by Shionogi Inc. at 39 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Ukraine, Argentina, Mexico, United States, Bulgaria and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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) (time frame: Up to 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.