A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis

Samsung Bioepis Co., Ltd.2 sites in 2 countries544 target enrollmentMay 2014

ConditionsRheumatoid Arthritis

InterventionsSB5 (proposed biosimilar to adalimumab)Humira (adalimumab)

DrugsHumira (adalimumab)SB5 (proposed biosimilar to adalimumab)

Overview

Phase: Phase 3
Intervention: SB5 (proposed biosimilar to adalimumab)
Conditions: Rheumatoid Arthritis
Sponsor: Samsung Bioepis Co., Ltd.
Enrollment: 544
Locations: 2
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 randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.

Detailed Description

Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid arthritis

Registry

clinicaltrials.gov

Start Date

May 2014

End Date

October 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

•Are male or female aged 18-75 years at the time of signing the informed consent form.
•Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (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:
•More than or equal to six swollen joints and more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation.
•Either erythrocyte sedimentation rate (Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 10 mg/dL at Screening.
•Must have been treated with MTX for a total of at least 6 months prior to Randomisation and must have been on both: a stable route of administration (oral or parenteral) and stable dose of MTX (10-25 mg/week) for at least 4 weeks prior to Screening.
•Female subjects who are not pregnant or nursing at Screening and Randomisation and who are not planning to become pregnant from Screening until 5 months after the last dose of IP.

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 Humira or SB
•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 (TB), have been recently exposed to a person with active TB, or are considered to have latent TB.
•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 a history of chronic or recurrent infection.
•Have any of the following conditions:
•History of congestive heart failure (New York Heart Association Class III/IV).
•History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
•History of demyelinating disorders.

Arms & Interventions

SB5 (proposed biosimilar to adalimumab)

SB5 40 mg every other week via subcutaneous injection

Intervention: SB5 (proposed biosimilar to adalimumab)

Humira (adalimumab)

Humira 40 mg every other week via subcutaneous injection

Intervention: Humira (adalimumab)

Humira (adalimumab)

Humira 40 mg every other week via subcutaneous injection

Intervention: SB5 (proposed biosimilar to adalimumab)

Outcomes

Primary Outcomes

American College of Rheumatology 20% Response Criteria (ACR20)

Time Frame: Week 24

Secondary Outcomes

American College of Rheumatology 50% Response Criteria (ACR50)(Week 24, Week 52)
Disease Activity Score Based on a 28 Joint Count (DAS28)(Week 24, Week 52)
ACR20(Week 52)