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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: Remicade (infliximab)
* Drug: SB2 (proposed biosimilar to infliximab)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB2 (proposed biosimilar to inflixmab)<br>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)<br> <br> |
| Active Comparator: Remicade (infliximab)<br>Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46 | Drug: Remicade (infliximab)<br> <br> |
| Experimental: Remicade (infliximab), switch to SB2<br>SB2 3mg/kg at week 54, 62, 70 | Drug: SB2 (proposed biosimilar to infliximab)<br> <br> |
| Active Comparator: Remicade (infliximab), continue as Remicade<br>Remicade 3mg/kg at week 54, 62, 70 | Drug: Remicade (infliximab)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology 20% Response Criteria (ACR20) |  | Week 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Infliximab, Biosimilar