Skip to main content
OpenTrials
Completed

NCT Number: NCT02762812

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ankylosing Spondylitis Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Saint Petersburg, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BCD-055

Biological

Other names: infliximab

Remicade®

Biological

Other names: infliximab

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biocad

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 5, 2016
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.