Trials / Completed
CompletedNCT03257852
A Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on Methotrexate
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 66 (actual)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX).
Detailed description
The study drug will be intravenously administered.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASP5094 | intravenously administration |
| DRUG | Placebo | intravenously administration |
| OTHER | Methotrexate therapy | MTX must have been continuously orally administered for at least 90 days prior to screening, with stable dosage for at least 28 days prior to screening, and will be continuously administered with the same dosage throughout the study period. |
Timeline
- Start date
- 2017-09-29
- Primary completion
- 2018-09-19
- Completion
- 2018-10-16
- First posted
- 2017-08-22
- Last updated
- 2024-10-31
Locations
31 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT03257852. Inclusion in this directory is not an endorsement.