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

Ankylosing Spondylitis Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762812
• Other study ID #: BCD-055-2
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2016
• Last updated: February 21, 2018
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: February 2018
• Source: Biocad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: July 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Biological:
• BCD-055

• Remicade®

Locations

Country	Name	City	State
Russian Federation	North-Western State Medical University n.a. I.I.Mechnikov	St.Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Biocad

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Frequency of AE/SAE	Frequency of AE/SAE	54 weeks
Secondary	Frequency of AE 3-4 grade CTCAE	Frequency of AE 3-4 grade CTCAE	54 weeks