Rheumatoid Arthritis
Conditions
Keywords
JTE-051, Active Rheumatoid Arthritis, Efficacy, Safety, Tolerability, Rheumatoid Arthritis
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.
Interventions
DRUGJTE-051
Active drug tablets containing JTE-051
DRUGPlacebo
Placebo tablets identical in appearance to the active drug tablets
Sponsors
Akros Pharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12 | 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: 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) |
| Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12 | 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: 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) |
| Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 | 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 | 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 |
| Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12 | 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: 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) |
| Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12 | 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 | Up to 16 Weeks | 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 | Week 12 | — |
| Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12 | 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. |
Countries
Argentina, Bulgaria, Colombia, Mexico, Peru, Poland, Romania, Russia, Ukraine, United States
Participant flow
Recruitment details
Written informed consent was obtained prior to performing any study-related procedures. A copy of the informed consent was provided to each subject enrolled in this study. To qualify for the study, subjects were required to satisfy defined criteria.
Pre-assignment details
Following informed consent signing, screening procedures to confirm eligibility were performed. 1. Total screened - 528 subjects 2. Screen failure - 268 subjects 3. Randomized Population - 259 subjects (excluded 1 randomized subject due to site scientific misconduct) 4. Intent-to-Treat Population - 257 subjects (excluded 2 randomized subjects: 1 was not dosed and 1 had no post-dose measurement) 5. Safety Population - 258 subjects (excluded 1 randomized subject: 1 was not dosed)
Participants by arm
| Arm | Count |
|---|---|
| JTE-051 50 mg JTE-051 50 mg orally once daily for 12 weeks | 51 |
| JTE-051 100 mg JTE-051 100 mg orally once daily for 12 weeks | 51 |
| JTE-051 150 mg JTE-051 150 mg orally once daily for 12 weeks | 52 |
| JTE-051 200 mg JTE-051 200 mg orally once daily for 12 weeks | 51 |
| Placebo Placebo orally once daily for 12 weeks | 52 |
| Total | 257 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 3 | 3 | 9 | 2 |
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 |
| Overall Study | Inclusion/Exclusion Criteria Not Met | 1 | 1 | 1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 3 | 1 | 2 | 2 |
Baseline characteristics
| Characteristic | Total | JTE-051 50 mg | JTE-051 100 mg | JTE-051 150 mg | JTE-051 200 mg | Placebo |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 34 Participants | 9 Participants | 3 Participants | 6 Participants | 8 Participants | 8 Participants |
| Age, Categorical Between 18 and 65 years | 223 Participants | 42 Participants | 48 Participants | 46 Participants | 43 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 133 Participants | 27 Participants | 27 Participants | 26 Participants | 27 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 124 Participants | 24 Participants | 24 Participants | 26 Participants | 24 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 32 Participants | 8 Participants | 8 Participants | 6 Participants | 7 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 62 Participants | 12 Participants | 9 Participants | 15 Participants | 10 Participants | 16 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 163 Participants | 31 Participants | 34 Participants | 31 Participants | 34 Participants | 33 Participants |
| Sex: Female, Male Female | 211 Participants | 41 Participants | 40 Participants | 44 Participants | 43 Participants | 43 Participants |
| Sex: Female, Male Male | 46 Participants | 10 Participants | 11 Participants | 8 Participants | 8 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 1 / 52 | 0 / 52 | 0 / 51 | 0 / 52 |
| other Total, other adverse events | 11 / 51 | 7 / 52 | 20 / 52 | 21 / 51 | 3 / 52 |
| serious Total, serious adverse events | 2 / 51 | 3 / 52 | 2 / 52 | 1 / 51 | 0 / 52 |
Outcome results
Primary
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: 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)
Time frame: Up to 12 Weeks
Population: Subjects in the Intent-to-Treat (ITT) population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at EOT (up to Week 12).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JTE-051 50 mg | 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) | 27 Participants |
| JTE-051 100 mg | 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) | 31 Participants |
| JTE-051 150 mg | 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) | 27 Participants |
| JTE-051 200 mg | 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) | 30 Participants |
| Placebo | 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) | 29 Participants |
p-value: 0.842Fisher Exact
p-value: 0.841Fisher Exact
p-value: 0.842Fisher Exact
p-value: >0.999Fisher Exact
Secondary
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
Time frame: Week 12
Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTE-051 50 mg | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 | -18.76 Score on a scale | Standard Deviation 14.768 |
| JTE-051 100 mg | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 | -22.40 Score on a scale | Standard Deviation 13.469 |
| JTE-051 150 mg | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 | -21.02 Score on a scale | Standard Deviation 16.153 |
| JTE-051 200 mg | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 | -21.24 Score on a scale | Standard Deviation 14.208 |
| Placebo | Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 | -17.19 Score on a scale | Standard Deviation 15.548 |
Secondary
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.
Time frame: Week 12
Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTE-051 50 mg | Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12 | -0.95 Score on a scale | Standard Deviation 1.039 |
| JTE-051 100 mg | Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12 | -1.23 Score on a scale | Standard Deviation 0.979 |
| JTE-051 150 mg | Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12 | -1.03 Score on a scale | Standard Deviation 1.123 |
| JTE-051 200 mg | Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12 | -1.10 Score on a scale | Standard Deviation 0.987 |
| Placebo | Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12 | -0.98 Score on a scale | Standard Deviation 1.123 |
Secondary
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.
Time frame: Week 12
Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTE-051 50 mg | Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12 | -0.52 Score on a scale | Standard Deviation 0.6 |
| JTE-051 100 mg | Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12 | -0.71 Score on a scale | Standard Deviation 0.629 |
| JTE-051 150 mg | Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12 | -0.60 Score on a scale | Standard Deviation 0.62 |
| JTE-051 200 mg | Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12 | -0.80 Score on a scale | Standard Deviation 0.727 |
| Placebo | Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12 | -0.47 Score on a scale | Standard Deviation 0.616 |
Secondary
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
Time frame: Week 12
Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTE-051 50 mg | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 | -18.14 Score on a scale | Standard Deviation 15.437 |
| JTE-051 100 mg | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 | -21.68 Score on a scale | Standard Deviation 13.275 |
| JTE-051 150 mg | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 | -19.41 Score on a scale | Standard Deviation 16.446 |
| JTE-051 200 mg | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 | -19.97 Score on a scale | Standard Deviation 14.244 |
| Placebo | Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 | -17.66 Score on a scale | Standard Deviation 16.816 |
Secondary
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.
Time frame: Up to 16 Weeks
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| JTE-051 50 mg | Number of Subjects With Treatment-related Adverse Events | Number of subjects with TEAEs | 26 Participants |
| JTE-051 50 mg | Number of Subjects With Treatment-related Adverse Events | Number of subjects with no TEAEs | 25 Participants |
| JTE-051 100 mg | Number of Subjects With Treatment-related Adverse Events | Number of subjects with TEAEs | 21 Participants |
| JTE-051 100 mg | Number of Subjects With Treatment-related Adverse Events | Number of subjects with no TEAEs | 31 Participants |
| JTE-051 150 mg | Number of Subjects With Treatment-related Adverse Events | Number of subjects with TEAEs | 32 Participants |
| JTE-051 150 mg | Number of Subjects With Treatment-related Adverse Events | Number of subjects with no TEAEs | 20 Participants |
| JTE-051 200 mg | Number of Subjects With Treatment-related Adverse Events | Number of subjects with no TEAEs | 17 Participants |
| JTE-051 200 mg | Number of Subjects With Treatment-related Adverse Events | Number of subjects with TEAEs | 34 Participants |
| Placebo | Number of Subjects With Treatment-related Adverse Events | Number of subjects with TEAEs | 22 Participants |
| Placebo | Number of Subjects With Treatment-related Adverse Events | Number of subjects with no TEAEs | 30 Participants |
Secondary
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: 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)
Time frame: Week 12
Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JTE-051 50 mg | Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12 | 26 Participants |
| JTE-051 100 mg | Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12 | 28 Participants |
| JTE-051 150 mg | Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12 | 25 Participants |
| JTE-051 200 mg | Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12 | 24 Participants |
| Placebo | Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12 | 28 Participants |
p-value: >0.999Fisher Exact
p-value: 0.832Fisher Exact
p-value: 0.682Fisher Exact
p-value: 0.665Fisher Exact
Secondary
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: 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)
Time frame: Week 12
Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JTE-051 50 mg | Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12 | 10 Participants |
| JTE-051 100 mg | Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12 | 12 Participants |
| JTE-051 150 mg | Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12 | 8 Participants |
| JTE-051 200 mg | Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12 | 11 Participants |
| Placebo | Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12 | 10 Participants |
p-value: >0.999Fisher Exact
p-value: 0.627Fisher Exact
p-value: 0.794Fisher Exact
p-value: 0.453Fisher Exact
Secondary
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: 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)
Time frame: Week 12
Population: Subjects in the ITT population (subjects who received at least one dose of JTE-051 or placebo, and had at least one post-baseline efficacy assessment during the double-blind treatment period) with available efficacy assessment(s) results at Week 12.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| JTE-051 50 mg | Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12 | 3 Participants |
| JTE-051 100 mg | Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12 | 5 Participants |
| JTE-051 150 mg | Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12 | 4 Participants |
| JTE-051 200 mg | Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12 | 4 Participants |
| Placebo | Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12 | 0 Participants |
p-value: 0.113Fisher Exact
p-value: 0.024Fisher Exact
p-value: 0.056Fisher Exact
p-value: 0.035Fisher Exact
Secondary
Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12
Time frame: Week 12
Population: Subjects in the Pharmacokinetic (PK) population (received at least one dose of JTE-051 and have at least one usable JTE-051 plasma concentration measurement) with available trough plasma concentrations of JTE-051 at Week 12.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| JTE-051 50 mg | Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12 | 119 ng/mL | Standard Deviation 96.9 |
| JTE-051 100 mg | Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12 | 178 ng/mL | Standard Deviation 156 |
| JTE-051 150 mg | Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12 | 312 ng/mL | Standard Deviation 252 |
| JTE-051 200 mg | Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12 | 354 ng/mL | Standard Deviation 281 |