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

Samsung Bioepis Co., Ltd.1 site in 1 country584 target enrollmentAugust 2013

ConditionsRheumatoid Arthritis

InterventionsSB2 (proposed biosimilar to infliximab)Remicade (infliximab)

DrugsRemicade (infliximab)SB2 (proposed biosimilar to infliximab)

Overview

Phase: Phase 3
Intervention: SB2 (proposed biosimilar to infliximab)
Conditions: Rheumatoid Arthritis
Sponsor: Samsung Bioepis Co., Ltd.
Enrollment: 584
Locations: 1
Primary Endpoint: American College of Rheumatology 20% Response Criteria (ACR20)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2013

End Date

September 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Samsung Bioepis Co., Ltd.

Responsible Party

Sponsor

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

Arms & Interventions

SB2 (proposed biosimilar to inflixmab)

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

Intervention: SB2 (proposed biosimilar to infliximab)

Remicade (infliximab)

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

Intervention: Remicade (infliximab)

Remicade (infliximab), switch to SB2

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

Intervention: SB2 (proposed biosimilar to infliximab)

Remicade (infliximab), continue as Remicade

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

Intervention: Remicade (infliximab)

Outcomes

Primary Outcomes

American College of Rheumatology 20% Response Criteria (ACR20)

Time Frame: Week 30

Secondary Outcomes

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)