Trials / Completed
CompletedNCT04135508
A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
A Multicenter, Randomized, Double-Blind, Phase III Clinical Trial Parallel Controlled With Humira to Evaluate the Efficacy and Safety of BAT1406 Injection in the Treatment of Ankylosing Spondylitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 554 (actual)
- Sponsor
- Bio-Thera Solutions · Industry
- Sex
- All
- Age
- 16 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
A Phase III Study Evaluate the Efficacy and Safety of BAT1406 and Humira
Detailed description
This is a multicenter, randomized, double-blind, active comparator, parallel two arm study to compare the efficacy, and to evaluate the safety, and immunogenicity of BAT1406 to Humira® in patients with active ankylosing spondylitis (AS) to demonstrate clinical equivalence of BAT1406 and Humira®.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BAT1406 | 40mg/0.8ml |
| DRUG | Humira | 40mg/0.8ml |
Timeline
- Start date
- 2016-12-13
- Primary completion
- 2018-03-22
- Completion
- 2018-05-31
- First posted
- 2019-10-22
- Last updated
- 2019-10-22
Source: ClinicalTrials.gov record NCT04135508. Inclusion in this directory is not an endorsement.