Trials / Completed
CompletedNCT03605251
Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.
An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 91 (actual)
- Sponsor
- Taiho Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TAS5315 low dose | Oral administration for 12 or 36 weeks |
| DRUG | TAS5315 high dose | Oral administration for 12 or 36 weeks |
| DRUG | Placebos | Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group) |
Timeline
- Start date
- 2018-08-30
- Primary completion
- 2019-11-30
- Completion
- 2020-05-28
- First posted
- 2018-07-30
- Last updated
- 2020-08-17
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT03605251. Inclusion in this directory is not an endorsement.