Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
NCT02762812 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 199
Last updated 2018-02-23
Summary
BCD-055-2 is international multi-center comparative double-blind randomized clinical trial to evaluate efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in patients with ankylosing spondylitis.
BCD-055 is biosimilar of infliximab (JSC "BIOCAD", Russia)
Conditions
Interventions
- BIOLOGICAL
-
BCD-055
- BIOLOGICAL
-
Remicade®
Sponsors & Collaborators
-
Biocad
lead INDUSTRY
Principal Investigators
-
Roman Ivanov, PhD · JCS BIOCAD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-01-31
- Primary Completion
- 2017-05-31
- Completion
- 2017-07-31
Countries
- Russia
Study Locations
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