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NCT02919475 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis
A Phase 2 study of Rheumatoid Arthritis, sponsored by Akros Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 260
- Enrollment target
- 20
- Study locations
NCT02919475: Completed Phase 2 study of Rheumatoid Arthritis, sponsored by Akros Pharma.
NCT02919475 is a Phase 2 study of Rheumatoid Arthritis that has completed, run by Akros Pharma. The registered enrollment target is 260 participants, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (94% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02919475, a Phase 2 study of Rheumatoid Arthritis, has completed, sponsored by Akros Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 260 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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 disea
Conditions Studied
Interventions
- DRUG Placebo
- DRUG JTE-051
Study Locations (20)
Other
- - Córdoba
- - San Juan
- - Lom
- - Plovdiv
- - Sevlievo
- - Sofia
Buenos Aires
- - La Plata
- - San Fernando
Arizona
- - Tucson
California
- - Upland
Florida
- - Clearwater
Tennessee
- - Hendersonville
Córdoba Province
- - Barrio Norte
Tucumán Province
- - San Miguel de Tucumán
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2016-09-14 |
| Est. Completion | 2018-06-25 |
| Phase | Phase 2 |
What the finished NCT02919475 record still lists
NCT02919475 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 4,689-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02919475 names 20 study sites across 14 states, led by Other, Buenos Aires, Arizona.
Frequently Asked Questions
What is clinical trial NCT02919475 about?
NCT02919475 is a clinical study titled "Study to Evaluate Efficacy, Safety and Tolerability of JTE-051 in Subjects With Active Rheumatoid Arthritis". 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.
What is the current status of trial NCT02919475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2016-09-14. Estimated completion is 2018-06-25.
What conditions does trial NCT02919475 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis.
What interventions are being tested in trial NCT02919475?
The interventions under investigation include: Placebo (DRUG), JTE-051 (DRUG).
Who is sponsoring clinical trial NCT02919475?
This trial is sponsored by Akros Pharma, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02919475 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Tennessee, Buenos Aires. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02919475's enrollment target sits among peer trials
260 71st of 197 higher than 127 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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