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

Primary Purpose

Ankylosing Spondylitis

Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
BCD-055
Remicade®
Sponsored by
Biocad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BCD-055

Remicade®

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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
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
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
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
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
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
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
Frequency of AE/SAE
Frequency of AE/SAE
Frequency of AE 3-4 grade CTCAE
Frequency of AE 3-4 grade CTCAE

Full Information

First Posted
April 4, 2016
Last Updated
February 21, 2018
Sponsor
Biocad
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1. Study Identification

Unique Protocol Identification Number
NCT02762812
Brief Title
Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biocad

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BCD-055
Arm Type
Experimental
Arm 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.
Arm Title
Remicade®
Arm Type
Active Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
BCD-055
Other Intervention Name(s)
infliximab
Intervention Type
Biological
Intervention Name(s)
Remicade®
Other Intervention Name(s)
infliximab
Primary Outcome Measure Information:
Title
Ratio of patients with ASAS20 response after 30 weeks of therapy
Description
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 Outcome Measure Information:
Title
Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy
Description
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
Title
Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy
Description
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
Title
Mean change in BASDAI after 14, 30 and 54 weeks of therapy
Description
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
Title
Mean change in BASMI after 14, 30 and 54 weeks of therapy
Description
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
Title
Mean change in BASFI after 14, 30 and 54 weeks of therapy
Description
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
Title
Mean change in MASES after 14, 30 and 54 weeks of therapy
Description
Mean change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) after 14, 30 and 54 weeks of therapy
Time Frame
Week 14, Week 30, Week 54
Title
Mean SF-36 score at screening and after 14, 30 and 54 weeks of therapy
Description
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
Time Frame
Week 14, Week 30, Week 54
Title
Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy
Description
Mean chest excursion at screening and after 14, 30 and 54 weeks of therapy
Time Frame
Week 14, Week 30, Week 54
Title
Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy
Description
Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy
Time Frame
Week 14, Week 30, Week 54
Title
Frequency of AE/SAE
Description
Frequency of AE/SAE
Time Frame
54 weeks
Title
Frequency of AE 3-4 grade CTCAE
Description
Frequency of AE 3-4 grade CTCAE
Time Frame
54 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Ivanov, PhD
Organizational Affiliation
JCS BIOCAD
Official's Role
Study Chair
Facility Information:
Facility Name
North-Western State Medical University n.a. I.I.Mechnikov
City
St.Petersburg
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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