A Study Comparing SB4 to Enbrel® 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 SB4 Compared to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895309
• Other study ID #: SB4-G31-RA
• Status: Completed
• Phase: Phase 3
• First received: July 3, 2013
• Last updated: December 2, 2015
• Start date: June 2013
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Samsung Bioepis Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• 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 SB4 compared to Enbrel in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects will be enrolled into an open label extension period. Subjects will receive SB4 for an additional 48 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 596
• Est. completion date: October 2015
• Est. primary completion date: April 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 but not exceeding 15 years prior to Screening

• 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 2 months after the last dose of investigational product

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 Enbrel or SB4

• 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.

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:
• Enbrel (etanercept)

• SB4 (proposed biosimilar to etanercept)

Locations

Country	Name	City	State
Poland	Investigational Site	Kielce
United Kingdom	Investigational Site	Southampton	Hampshire

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Bioepis Co., Ltd.

Countries where clinical trial is conducted

Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology 20% response criteria (ACR20)		Week 24	No
Secondary	ACR20		Week 52	No
Secondary	American College of Rheumatology 50% response criteria (ACR50)		Week 24, Week 52	No
Secondary	Disease activity score based on a 28 joint count (DAS28)		Week 24, Week 52	No
Secondary	Patients with adverse events/serious adverse events		Week 100	No