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

February 21, 2018 updated by: Biocad

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-055-2 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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • St.Petersburg, Russian Federation
        • North-Western State Medical University n.a. I.I.Mechnikov

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • infliximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 14, 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 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
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
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 change in Bath Ankylosing Spondylitis Metrology Index (BASMI), after 14, 30 and 54 weeks of therapy
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 Bath Ankylosing Spondylitis Functional Index (BASFI) after 14, 30 and 54 weeks of therapy
Week 14, Week 30, Week 54
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
Week 14, Week 30, Week 54
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
Week 14, Week 30, Week 54
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
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
Mean quantity of abnormal peripheral joints after 14, 30 and 54 weeks of therapy
Week 14, Week 30, Week 54
Frequency of AE/SAE
Time Frame: 54 weeks
Frequency of AE/SAE
54 weeks
Frequency of AE 3-4 grade CTCAE
Time Frame: 54 weeks
Frequency of AE 3-4 grade CTCAE
54 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biocad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

April 4, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 5, 2016

Study Record Updates

Last Update Posted (Actual)

February 23, 2018

Last Update Submitted That Met QC Criteria

February 21, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCD-055-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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