Trials / Completed
CompletedNCT03522415
Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis
A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of HLX01 (Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection) Combined With MTX Therapy in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 275 (actual)
- Sponsor
- Shanghai Henlius Biotech · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To compare the efficacy between the HLX01 group and the placebo group through the proportion of subjects meeting the ACR20 improvement criteria for remission
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HLX01 | HLX01,Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection is recombinant human-mouse chimeric anti-cd20 CD20 monoclonal antibody. |
| DRUG | Methotrexate（MTX） | Methotrexate is a slow-acting antirheumatic drug. |
Timeline
- Start date
- 2018-05-28
- Primary completion
- 2020-04-05
- Completion
- 2020-09-11
- First posted
- 2018-05-11
- Last updated
- 2022-05-09
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03522415. Inclusion in this directory is not an endorsement.