NCT02762812

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 5, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

April 4, 2016

Last Update Submit

February 21, 2018

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • Ratio of patients with ASAS20 response after 30 weeks of therapy

    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 Outcomes (11)

  • Ratio of patients with ASAS20 response after 14 and 54 weeks of therapy

    Week 14, Week 54

  • Ratio of patients with ASAS40 response after 14, 30 and 54 weeks of therapy

    Week 14, Week 30, Week 54

  • Mean change in 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

    Week 14, Week 30, Week 54

  • Mean change in BASFI after 14, 30 and 54 weeks of therapy

    Week 14, Week 30, Week 54

  • +6 more secondary outcomes

Study Arms (2)

BCD-055

EXPERIMENTAL

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

Remicade®

ACTIVE COMPARATOR

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®

Interventions

BCD-055BIOLOGICAL
Also known as: infliximab
BCD-055
Remicade®BIOLOGICAL
Also known as: infliximab
Remicade®

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Saint Petersburg, Russia

Location

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

BCD-055Infliximab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Roman Ivanov, PhD

    JCS BIOCAD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2016

First Posted

May 5, 2016

Study Start

January 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02

Locations

RU(1)