Trials / Completed
CompletedNCT03830203
Comparative Study of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
A Randomized, Double-Blind, Parallel-Group, Active-Control Study to Compare the Efficacy and Safety of BAT1806 to RoActemra® in Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 621 (actual)
- Sponsor
- Bio-Thera Solutions · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a Phase 3, multicenter, multinational, randomized, double-blind, parallel-group, active-control study to compare efficacy, safety, immunogenicity, and PK of BAT1806 compared with RoActemra in subjects with RA that is inadequately controlled by MTX. The study is composed of a ≤ 28-day screening period, a 24-week initial treatment period (TP1), a 24 week secondary treatment period (TP2), and an extra 4-week follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAT1806 | 8 mg/kg |
| DRUG | Actemra(EU-licensed) | 8 mg/kg |
Timeline
- Start date
- 2018-12-19
- Primary completion
- 2021-01-05
- Completion
- 2021-01-05
- First posted
- 2019-02-05
- Last updated
- 2021-11-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03830203. Inclusion in this directory is not an endorsement.