Trials / Completed
CompletedNCT03275025
A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation of YRA-1909 in Patients With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 116 (actual)
- Sponsor
- Yungjin Pharm. Co., Ltd. · Industry
- Sex
- All
- Age
- 19 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | YRA-1909 low dose | A low dose of YRA-1909; daily oral intake for 12 weeks |
| DRUG | YRA-1909 mid dose | A mid dose of YRA-1909; daily oral intake for 12 weeks |
| DRUG | YRA-1909 high dose | A high dose of YRA-1909; daily oral intake for 12 weeks |
| DRUG | Placebo | Matching placebo dosing with daily oral intake for 12 weeks |
Timeline
- Start date
- 2017-04-01
- Primary completion
- 2019-11-19
- Completion
- 2019-11-19
- First posted
- 2017-09-07
- Last updated
- 2021-05-03
Locations
14 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03275025. Inclusion in this directory is not an endorsement.