Trials / Completed
CompletedNCT02762838
Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
International Multi-center Comparative Double-blind Randomized Clinical Trial of Efficacy and Safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 426 (actual)
- Sponsor
- Biocad · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid arthritis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | BCD-055 | BCD-055 is infliximab biosimilar |
| BIOLOGICAL | Remicade® | |
| DRUG | Methotrexate | All patients will receive methotrexate in a dose from 10 to 25 mg per week. |
| DRUG | Folic acid | All patients will receive folic acid in a dose of 5 mg per week. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2018-07-01
- Completion
- 2018-07-01
- First posted
- 2016-05-05
- Last updated
- 2019-06-14
Locations
39 sites across 3 countries: Belarus, India, Russia
Source: ClinicalTrials.gov record NCT02762838. Inclusion in this directory is not an endorsement.