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Trial record 61 of 299 for:    "Ankylosing spondylitis"

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

Tracking Information
First Submitted Date  ICMJE April 4, 2016
First Posted Date  ICMJE May 5, 2016
Last Update Posted Date February 23, 2018
Study Start Date  ICMJE January 2016
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02762812 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 21, 2018)
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Frequency of AE/SAE [ Time Frame: 54 weeks ]
    Frequency of AE/SAE
  • Frequency of AE 3-4 grade CTCAE [ Time Frame: 54 weeks ]
    Frequency of AE 3-4 grade CTCAE
Original Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2016)
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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
  • 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
  • Mean chest excursion at screening and 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 [ Time Frame: Week 14, Week 30, Week 54 ]
  • Frequency of AE/SAE [ Time Frame: 54 weeks ]
  • Frequency of AE 3-4 grade CTCAE [ Time Frame: 54 weeks ]
  • Frequency of early withdrawal due to AE/SAE [ Time Frame: 54 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Clinical Trial to Evaluate Efficacy and Safety of BCD-055 and Remicade® in Patients With Ankylosing Spondylitis
Official Title  ICMJE 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
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)

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Biological: BCD-055
    Other Name: infliximab
  • Biological: Remicade®
    Other Name: infliximab
Study Arms  ICMJE
  • 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.
    Intervention: Biological: BCD-055
  • 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.
    Intervention: Biological: Remicade®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 21, 2018)
199
Original Estimated Enrollment  ICMJE
 (submitted: May 3, 2016)
198
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02762812
Other Study ID Numbers  ICMJE BCD-055-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Biocad
Study Sponsor  ICMJE Biocad
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Roman Ivanov, PhD JCS BIOCAD
PRS Account Biocad
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP