A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

• Conditions: Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO.; MedDRA version: 17.1Level: SOCClassification code 10021428Term: Immune system disordersSystem Organ Class: 10021428 - Immune system disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-005026-30-BG
• Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03-05
• Last Update Posted: 7 April 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 596

Inclusion Criteria

1. Are male or female aged 18–75 years at the time of signing the consent form.
2. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria
3. Have more than or equal to six swollen joints, more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation and either erythrocyte sedimentation rate (Westergren) = 28 mm/h or serum C-reactive protein = 1.0 mg/dL at Screening.
4. 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 orally or parenterally for at least 4 weeks prior to Screening.
5. 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 (IP).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 520
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 76

Exclusion Criteria

1. Have been treated previously with any biological agents including any tumour necrosis factor inhibitor.
2. Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4.
3. Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus.
4. Have a current diagnosis of active tuberculosis
5. 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.
6. Have any of the following conditions
a. Other inflammatory or rheumatic diseases.
b. History of any malignancy within the previous 5 years prior to Screening
c. History of lymphoproliferative disease including lymphoma.
d. History of congestive heart failure
e. Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
f History of demyelinating disorders.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified