Phase 2
Completed N=259
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02919475 ↗Enrolled (actual)
259
Serious AEs
3.1%
Results posted
Jun 2021
Primary outcomePrimary: 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; 31; 27; 30 Participants — p=0.842
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
27; 31; 27; 30; 29 | 0.842 |
| SECONDARY Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12 |
26; 28; 25; 24; 28 | >0.999 |
| SECONDARY Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12 |
10; 12; 8; 11; 10 | >0.999 |
| SECONDARY Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12 |
3; 5; 4; 4; 0 | 0.113 |
| SECONDARY Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12 |
-18.14; -21.68; -19.41; -19.97; -17.66 | — |
| SECONDARY Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12 |
-18.76; -22.40; -21.02; -21.24; -17.19 | — |
| SECONDARY Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12 |
-0.95; -1.23; -1.03; -1.10; -0.98 | — |
| SECONDARY Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12 |
-0.52; -0.71; -0.60; -0.80; -0.47 | — |
| SECONDARY Number of Subjects With Treatment-related Adverse Events |
26; 21; 32; 34; 22; 25 | — |
| SECONDARY Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12 |
119; 178; 312; 354 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02919475). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.