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A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Remicade (infliximab)
SB2 (proposed biosimilar to infliximab)
Sponsored by
Samsung Bioepis Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Infliximab, Biosimilar

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months
  • Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL
  • Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
  • Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 6 months after the last dose of investigational product

Inclusion Criteria for Transition-Extension Period:

  • Have been enrolled and completed the scheduled Week 54 visit of the randomised, double-blind period of the SB2-G31-RA study
  • In the opinion of the Investigator, subjects who may benefit from continuing IP treatment (either SB2 or Remicade), understand the implications of taking part in the study and willing to participate in the transition-extension period

Exclusion Criteria:

  • Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
  • Have a known hypersensitivity to human immunoglobulin proteins or other components of Remicade or SB2
  • Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
  • Have a current diagnosis of active tuberculosis
  • Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
  • Have any of the following conditions

    1. Other inflammatory or rheumatic diseases.
    2. History of any malignancy within the previous 5 years prior to Screening
    3. History of lymphoproliferative disease including lymphoma.
    4. History of congestive heart failure
    5. Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
    6. History of demyelinating disorders.

Exclusion Criteria for Transition-Extension Period:

  • Have been withdrawn from the SB2-G31-RA study for any reason
  • Have had any significant medical conditions, such as an occurrence of a serious AE (SAE) or intolerance of SB2 or Remicade during the randomised, double-blind period of the SB2-G31-RA study which may render the subject unsuitable to participate in the transition-extension period, at the discretion of the Investigator

Sites / Locations

  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

SB2 (proposed biosimilar to inflixmab)

Remicade (infliximab)

Remicade (infliximab), switch to SB2

Remicade (infliximab), continue as Remicade

Arm Description

SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70

Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46

SB2 3mg/kg at week 54, 62, 70

Remicade 3mg/kg at week 54, 62, 70

Outcomes

Primary Outcome Measures

American College of Rheumatology 20% Response Criteria (ACR20)

Secondary Outcome Measures

ACR20
American College of Rheumatology 50% Response Criteria (ACR50)
Disease Activity Score Based on a 28 Joint Count (DAS28)

Full Information

First Posted
September 2, 2013
Last Updated
August 16, 2017
Sponsor
Samsung Bioepis Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01936181
Brief Title
A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Official Title
A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Bioepis Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Infliximab, Biosimilar

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
584 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SB2 (proposed biosimilar to inflixmab)
Arm Type
Experimental
Arm Description
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
Arm Title
Remicade (infliximab)
Arm Type
Active Comparator
Arm Description
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
Arm Title
Remicade (infliximab), switch to SB2
Arm Type
Experimental
Arm Description
SB2 3mg/kg at week 54, 62, 70
Arm Title
Remicade (infliximab), continue as Remicade
Arm Type
Active Comparator
Arm Description
Remicade 3mg/kg at week 54, 62, 70
Intervention Type
Drug
Intervention Name(s)
Remicade (infliximab)
Intervention Type
Drug
Intervention Name(s)
SB2 (proposed biosimilar to infliximab)
Primary Outcome Measure Information:
Title
American College of Rheumatology 20% Response Criteria (ACR20)
Time Frame
Week 30
Secondary Outcome Measure Information:
Title
ACR20
Time Frame
Week 54, Week 78
Title
American College of Rheumatology 50% Response Criteria (ACR50)
Time Frame
Week 30, Week 54, Week 78
Title
Disease Activity Score Based on a 28 Joint Count (DAS28)
Time Frame
Week 30, Week 54, Week 78

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 6 months after the last dose of investigational product Inclusion Criteria for Transition-Extension Period: Have been enrolled and completed the scheduled Week 54 visit of the randomised, double-blind period of the SB2-G31-RA study In the opinion of the Investigator, subjects who may benefit from continuing IP treatment (either SB2 or Remicade), understand the implications of taking part in the study and willing to participate in the transition-extension period Exclusion Criteria: Have been treated previously with any biological agents including any tumour necrosis factor inhibitor Have a known hypersensitivity to human immunoglobulin proteins or other components of Remicade or SB2 Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus Have a current diagnosis of active tuberculosis Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation. Have any of the following conditions Other inflammatory or rheumatic diseases. History of any malignancy within the previous 5 years prior to Screening History of lymphoproliferative disease including lymphoma. History of congestive heart failure Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound). History of demyelinating disorders. Exclusion Criteria for Transition-Extension Period: Have been withdrawn from the SB2-G31-RA study for any reason Have had any significant medical conditions, such as an occurrence of a serious AE (SAE) or intolerance of SB2 or Remicade during the randomised, double-blind period of the SB2-G31-RA study which may render the subject unsuitable to participate in the transition-extension period, at the discretion of the Investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jung-Yoon Choe, M.D., Ph.D.
Organizational Affiliation
Daegu Catholic University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Investigational Site
City
Hristo Botev Str.
State/Province
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Facility Name
Investigational Site
City
Santariskiu
State/Province
Vilnius
ZIP/Postal Code
08661
Country
Lithuania

12. IPD Sharing Statement

Citations:
PubMed Identifier
31958281
Citation
Smolen JS, Choe JY, Weinblatt ME, Emery P, Keystone E, Genovese MC, Myung G, Hong E, Baek I, Ghil J. Pooled analysis of TNF inhibitor biosimilar studies comparing radiographic progression by disease activity states in rheumatoid arthritis. RMD Open. 2020 Jan;6(1):e001096. doi: 10.1136/rmdopen-2019-001096.
Results Reference
derived
PubMed Identifier
29042358
Citation
Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Lee Y, Rho YH. Safety, immunogenicity and efficacy after switching from reference infliximab to biosimilar SB2 compared with continuing reference infliximab and SB2 in patients with rheumatoid arthritis: results of a randomised, double-blind, phase III transition study. Ann Rheum Dis. 2018 Feb;77(2):234-240. doi: 10.1136/annrheumdis-2017-211741. Epub 2017 Oct 17.
Results Reference
derived
PubMed Identifier
28957563
Citation
Smolen JS, Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH. Comparing biosimilar SB2 with reference infliximab after 54 weeks of a double-blind trial: clinical, structural and safety results. Rheumatology (Oxford). 2017 Oct 1;56(10):1771-1779. doi: 10.1093/rheumatology/kex254.
Results Reference
derived
PubMed Identifier
26318384
Citation
Choe JY, Prodanovic N, Niebrzydowski J, Staykov I, Dokoupilova E, Baranauskaite A, Yatsyshyn R, Mekic M, Porawska W, Ciferska H, Jedrychowicz-Rosiak K, Zielinska A, Choi J, Rho YH, Smolen JS. A randomised, double-blind, phase III study comparing SB2, an infliximab biosimilar, to the infliximab reference product Remicade in patients with moderate to severe rheumatoid arthritis despite methotrexate therapy. Ann Rheum Dis. 2017 Jan;76(1):58-64. doi: 10.1136/annrheumdis-2015-207764. Epub 2015 Aug 28.
Results Reference
derived

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A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

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