Trials / Completed
CompletedNCT02744196
Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line Biological Therapy of Patients With Active Rheumatoid Arthritis
Multicenter Comparative Randomised Double-blind Placebo-controlled Clinical Trial to Evaluate Efficacy and Safety of Acellbia® (JSC "BIOCAD") With Methotrexate in First Line of Biological Therapy of Patients With Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 159 (actual)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The mail goal of this study is to establish superiority in efficacy of Acellbia® applied in a dose of 600 mg (Day 1 and Day 15) in combination with methotrexate in patients with active RA seropositive previously untreated with biological therapy, compared to standard therapy with methotrexate.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Acellbia | Acellbia is rituximab biosimilar, monoclonal antibody which binds CD20. |
| DRUG | Placebo | Placebo solution will look identical to the Acellbia solution. |
| DRUG | Methotrexate |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2017-02-01
- Completion
- 2017-08-01
- First posted
- 2016-04-20
- Last updated
- 2018-01-25
Source: ClinicalTrials.gov record NCT02744196. Inclusion in this directory is not an endorsement.