Trials / Completed
CompletedNCT03355872
A Randomised, Double-blind, Phase I/II Study to Evaluate the PK, PD, Safety, and Efficacy Between HLX01 and Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis and Inadequate Response to Treatment With DMARDs
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 194 (actual)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
To compare the PK profiles of HLX01 and Rituximab in Chinese patients with moderate to severe rheumatoid arthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HLX01 | Biosimilar of Rituximab |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2018-08-01
- Completion
- 2018-08-01
- First posted
- 2017-11-28
- Last updated
- 2022-05-09
Source: ClinicalTrials.gov record NCT03355872. Inclusion in this directory is not an endorsement.