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

Biocad

Status and phase: Completed; Phase 3

Conditions: Ankylosing Spondylitis

Treatments: Biological: BCD-055; Biological: Remicade®

Study type: Interventional

Funder types: Industry

Identifiers

NCT02762812

BCD-055-2

Details and patient eligibility

About

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)

Enrollment: 199 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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199 participants in 2 patient groups

BCD-055

Experimental group

Description:

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.

Treatment:

Biological: BCD-055

Remicade®

Active Comparator group

Description:

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.

Treatment:

Biological: Remicade®