Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis

Study Overview
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Brief Summary
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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)

Official Title
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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

Conditions
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Ankylosing Spondylitis

Intervention / Treatment
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* Biological: BCD-055
* Biological: Remicade®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BCD-055<br>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. | Biological: BCD-055<br> <br> * Other names: infliximab;|
| Active Comparator: Remicade®<br>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. | Biological: Remicade®<br> <br> * Other names: infliximab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of patients with ASAS20 response after 30 weeks of therapy | 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. | Week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy | 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. | Week 14, Week 54 | 
| Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy | 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. | Week 14, Week 30, Week 54 | 
| Mean change in BASDAI after 14, 30 and 54 weeks of therapy | Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | 
| Mean change in BASMI after 14, 30 and 54 weeks of therapy | Mean change in Bath Ankylosing Spondylitis Metrology Index (BASMI), after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | 
| Mean change in BASFI after 14, 30 and 54 weeks of therapy | Mean change in Bath Ankylosing Spondylitis Functional Index (BASFI) after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | 
| Mean change in MASES after 14, 30 and 54 weeks of therapy | Mean change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) after 14, 30 and 54 weeks of therapy | Week 14, Week 30, Week 54 | 
| Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy | 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 | Week 14, Week 30, Week 54 | 
| Mean chest excursion at screening and 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 quantity of abnormal peripheral joints 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 | 
| Frequency of AE/SAE | Frequency of AE/SAE | 54 weeks | 
| Frequency of AE 3-4 grade CTCAE | Frequency of AE 3-4 grade CTCAE | 54 weeks |