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

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ClinicalTrials.gov Identifier: NCT02762812
Recruitment Status : Completed
First Posted : May 5, 2016
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Biocad

Study Description
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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)


Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Biological: BCD-055 Biological: Remicade® Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 199 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab

Arms and Interventions
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Arm Intervention/treatment
Experimental: BCD-055
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.
 Biological: BCD-055
Other Name: infliximab
Active Comparator: Remicade®
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.
 Biological: Remicade®
Other Name: infliximab


Outcome Measures
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Primary Outcome Measures :
  1. Ratio of patients with ASAS20 response after 30 weeks of therapy [ Time Frame: Week 30 ]
    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 :
  1. Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy [ Time Frame: Week 14, Week 54 ]
    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.

  2. 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 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.

  3. Mean change in BASDAI after 14, 30 and 54 weeks of therapy [ Time Frame: Week 14, Week 30, Week 54 ]
    Mean change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) after 14, 30 and 54 weeks of therapy

  4. Mean change in BASMI after 14, 30 and 54 weeks of therapy [ Time Frame: Week 14, Week 30, Week 54 ]
    Mean change in Bath Ankylosing Spondylitis Metrology Index (BASMI), after 14, 30 and 54 weeks of therapy

  5. Mean change in BASFI after 14, 30 and 54 weeks of therapy [ Time Frame: Week 14, Week 30, Week 54 ]
    Mean change in Bath Ankylosing Spondylitis Functional Index (BASFI) after 14, 30 and 54 weeks of therapy

  6. Mean change in MASES after 14, 30 and 54 weeks of therapy [ Time Frame: Week 14, Week 30, Week 54 ]
    Mean change in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) after 14, 30 and 54 weeks of therapy

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

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

  9. Mean quantity of abnormal peripheral joints 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

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

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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02762812


Locations
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Russian Federation
North-Western State Medical University n.a. I.I.Mechnikov
St.Petersburg, Russian Federation
Sponsors and Collaborators
Biocad
Investigators
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Study Chair: Roman Ivanov, PhD JCS BIOCAD
More Information
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Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT02762812    
Other Study ID Numbers: BCD-055-2
First Posted: May 5, 2016    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
 Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents