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

NCT01936181 | Completed Phase 3 Results DMC

• 1 other identifier: SB2-G31-RA
• Study Type: interventional
• Target: 584
• Locations: 2 countries
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Infliximab; Biosimilar

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology 20% Response Criteria (ACR20)

  Week 30

Secondary Outcomes (3)

• ACR20

  Week 54, Week 78

• American College of Rheumatology 50% Response Criteria (ACR50)

  Week 30, Week 54, Week 78

• Disease Activity Score Based on a 28 Joint Count (DAS28)

  Week 30, Week 54, Week 78

Study Arms (4)

SB2 (proposed biosimilar to inflixmab)

EXPERIMENTAL

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

Drug: SB2 (proposed biosimilar to infliximab)

Remicade (infliximab)

ACTIVE COMPARATOR

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

Drug: Remicade (infliximab)

Remicade (infliximab), switch to SB2

EXPERIMENTAL

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

Drug: SB2 (proposed biosimilar to infliximab)

Remicade (infliximab), continue as Remicade

ACTIVE COMPARATOR

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

Drug: Remicade (infliximab)

Interventions

Remicade (infliximab) DRUG

Remicade (infliximab); Remicade (infliximab), continue as Remicade

SB2 (proposed biosimilar to infliximab) DRUG

Remicade (infliximab), switch to SB2; SB2 (proposed biosimilar to inflixmab)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Samsung Bioepis Co., Ltd.: lead

Study Sites (2)

Investigational Site

Hristo Botev Str., Sliven, 8800, Bulgaria

Location

Investigational Site

Santariskiu, Vilnius County, 08661, Lithuania

Location

Related Publications (4)

• 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.

  PMID: 31958281 DERIVED

• 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.

  PMID: 29042358 DERIVED

• 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.

  PMID: 28957563 DERIVED

• 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.

  PMID: 26318384 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Director, Clinical Development
• Organization: Samsung Bioepis

+82 31 8061 4534

Study Officials

• Jung-Yoon Choe, M.D., Ph.D.

  Daegu Catholic University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 5, 2013
• Study Start: August 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2015
• Last Updated: September 14, 2017
• Results First Posted: August 29, 2016

Record last verified: 2017-08

Locations

BU (1); LI (1)