Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
- Conditions
- Ankylosing Spondylitis
- Interventions
- Biological: BCD-055Biological: Remicade®
- Registration Number
- NCT02762812
- Lead Sponsor
- Biocad
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 199
- Signed informed consent
- Active ankylosing spondylitis according to modified criteria of New York classification (1984), that was diagnosed at least 3 months prior to screening.
- Active disease according to BASDAI (score 4 or more) if nonsteroidal antiinflammatory drugs were used in the last 3 month prior to screening.
- Mean backache intensity equals 4 points or more.
- Previous therapy of ankylosing spondylitis with monoclonal antibodies (including tumor necrosis factor)
- Total spinal ankylosis
- History of tuberculosis
- Body mass more than 120 kg
- Patient is taking corticosteroids for up to 4 weeks in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent.
- Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization.
- Prior use of alkylating agents for up to 12 months prior to signing informed consent.
- Intraarticular use of corticosteroids for up to 4 weeks before randomization.
- Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BCD-055 BCD-055 Patients in this group will receive BCD-055 in a dose of 5 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Wekk 38, Week 46, Week 54. Remicade® Remicade® Patients in this group will receive Remicade® in a dose of 5 mg/kg on Week 0, Week 2, Week 6, Week 14, Week 22, Week 30, Wekk 38, Week 46, Week 54.
- Primary Outcome Measures
Name Time Method Ratio of patients with ASAS20 response after 30 weeks of therapy Week 30 Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 30 weeks of therapy with BCD-055.
- Secondary Outcome Measures
Name Time Method Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy Week 14, Week 54 Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 20% or more after 14 and 54 weeks of therapy with BCD-055.
Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 Ratio of patients who developed a decrease in ankylosing spondylitis assessment score (ASAS) by 40% or more after 14, 30 and 54 weeks of therapy with BCD-055.
Frequency of AE/SAE 54 weeks Frequency of AE/SAE
Mean change in BASDAI after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) after 14, 30 and 54 weeks of therapy
Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 Mean score of quality of life as assessed by Short Form-36 (SF-36) at screening and after 14, 30 and 54 weeks of therapy
Frequency of AE 3-4 grade CTCAE 54 weeks Frequency of AE 3-4 grade CTCAE
Mean change in BASMI after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 Mean change in Bath Ankylosing Spondylitis Metrology Index (BASMI), after 14, 30 and 54 weeks of therapy
Mean change in BASFI after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 Mean change in Bath Ankylosing Spondylitis Functional Index (BASFI) after 14, 30 and 54 weeks of therapy
Mean change in MASES after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 Mean change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) after 14, 30 and 54 weeks of therapy
Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy
Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy Week 14, Week 30, Week 54 Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy
Trial Locations
- Locations (1)
North-Western State Medical University n.a. I.I.Mechnikov
🇷🇺St.Petersburg, Russian Federation