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

Biocad199 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

199

Conditions

Ankylosing Spondylitis

Interventions

BCD-055BIOLOGICAL

Remicade®BIOLOGICAL

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

North-Western State Medical University n.a. I.I.Mechnikov

Saint Petersburg, Russia

Outcomes

Primary Outcomes

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.

Time frame: Week 30

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Week 14, Week 30, Week 54

Mean change in MASES after 14, 30 and 54 weeks of therapy

Data from ClinicalTrials.gov

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