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

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 theconsent 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).
Subjects must meet all of the following criteria to be enrolled in the
open-label, extension period:
1. Have completed the scheduled Week 52 visit of the randomised,
double-blind period of SB4-G31-RA study, may benefit from SB4
treatment at the discretion of the Investigator and are willing to
participate in the open-label, extension period.
2. Must be able to provide informed consent for the open-label,
extension period, which must be obtained prior to the first
administration of IP for the open-label, extension period.
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.
Subjects meeting any of the following criteria must not be enrolled in the open-label, extension period:
1. Have been withdrawn from SB4-G31-RA Study for any reason.
2. Have had any significant medical conditions, such as an occurrence of
a serious adverse event (SAE) or intolerance of SB4 or Enbrel during the
52 weeks of randomised, double-blind period which may render the
subjects undesirable to participate in the study at the discretion of the
Investigator.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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