- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02762812
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
-
-
-
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.
|
Other Names:
|
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.
|
Other Names:
|
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
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.
Clinical Trials on Ankylosing Spondylitis
-
Shanghai Junshi Bioscience Co., Ltd.Sponsor GmbHRecruitingActive Ankylosing SpondylitisChina
-
AbbVieBoehringer IngelheimCompletedAnkylosing Spondylitis (AS)
-
Sun Yat-sen UniversityUnknownEarly Ankylosing Spondylitis
-
Tongji HospitalWuhan Central Hospital; Wuhan Hospital of Traditional Chinese MedicineRecruitingAnkylosing Spondylitis (AS)China
-
Chinese University of Hong KongCompletedAnkylosing Spondylitis(AS)China
-
AbbVieCompletedAnkylosing Spondylitis (AS)United States, Australia, Belgium, Canada, Croatia, Czechia, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, New Zealand, Poland, Portugal, Spain, Sweden, United Kingdom
-
AbbVieCompletedAnkylosing Spondylitis (AS)Taiwan
-
Jiangsu vcare pharmaceutical technology co., LTDRecruitingActive Ankylosing SpondylitisChina
-
Tianjin Hemay Pharmaceutical Co., LtdCompletedActive Ankylosing SpondylitisChina
-
Assiut UniversityUnknownActive Sacroiliitis in Ankylosing Spondylitis
Clinical Trials on Remicade®
-
Assistance Publique - Hôpitaux de ParisCompletedRheumatoid Arthritis | Uveitis | Crohn's Disease | SpondyloarthritisFrance
-
AmgenCompletedArthritis, RheumatoidUnited States, Spain, Australia, Bulgaria, Germany, Poland, Canada, Czechia, Hungary
-
Ohio State University Comprehensive Cancer CenterCompletedGraft-Versus-Host DiseaseUnited States
-
Merck Sharp & Dohme LLCCompleted
-
Samsung Bioepis Co., Ltd.Completed
-
Merck Sharp & Dohme LLCCentocor, Inc.CompletedCrohn's Disease
-
Merck Sharp & Dohme LLCCentocor, Inc.Completed
-
BiocadCompletedAnkylosing SpondylitisRussian Federation, Belarus
-
National Institute of Allergy and Infectious Diseases...Autoimmunity Centers of ExcellenceCompleted
-
Merck Sharp & Dohme LLCCompleted