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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01936181
• Other study ID #: SB2-G31-RA
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2013
• Last updated: November 30, 2015
• Start date: August 2013
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: Samsung Bioepis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 584
• Est. completion date: September 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Remicade (infliximab)

• SB2 (proposed biosimilar to infliximab)

Locations

Country	Name	City	State
Bulgaria	Investigational Site	Hristo Botev Str.	Sliven
Lithuania	Investigational Site	Santariskiu	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

Bulgaria,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology 20% response criteria (ACR20)		Week 30	No
Secondary	ACR20		Week 54, Week 78	No
Secondary	American College of Rheumatology 50% response criteria (ACR50)		Week 30, Week 54, Week 78	No
Secondary	Disease activity score based on a 28 joint count (DAS28)		Week 30, Week 54, Week 78	No