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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02762812
• Date of registration: 04/04/2016
• Prospective Registration: No
• Primary sponsor: Biocad
• Public title: Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
• Scientific title: 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
• Date of first enrolment: January 2016
• Target sample size: 199
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02762812
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Russian Federation

Contacts

• Name: Roman Ivanov, PhD
• Affiliation: JCS BIOCAD

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Biological: BCD-055

Biological: Remicade®

Primary Outcome(s)

Ratio of patients with ASAS20 response after 30 weeks of therapy [Time Frame: Week 30]

Secondary Outcome(s)

Mean change in BASDAI 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 [Time Frame: Week 14, Week 30, Week 54]

Mean change in BASMI after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Frequency of AE/SAE [Time Frame: 54 weeks]

Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Frequency of AE 3-4 grade CTCAE [Time Frame: 54 weeks]

Mean change in MASES after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy [Time Frame: Week 14, Week 54]

Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy [Time Frame: Week 14, Week 30, Week 54]

Secondary ID(s)

BCD-055-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors