A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis

Conditions: Rheumatoid Arthritis
MedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2012-005733-37-LT

Lead Sponsor: Samsung Bioepis Co., Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 584

Inclusion Criteria

1. Are male or female aged 18–75 years at the time of signing the informed consent form.
2. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria for at least 6 months prior to Screening.
3. Have moderate to severe active disease despite MTX therapy defined as:
a. 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.
b. 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 6 months after the last dose of investigational product (IP)
Subjects must meet all of the following criteria to be enrolled in the transition-extension period:
1. Have been enrolled and completed the scheduled Week 54 visit of the randomised, double-blind period of the SB2-G31-RA study.
2. 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.
3. Female subjects who are not pregnant or nursing and who are not planning to become pregnant until 6 months after the last dose of IP.
4. Subjects of child-bearing potential (female or male) who agree to use at least two forms of appropriate contraception (e.g., established use of oral, injected or implanted hormonal contraceptive, placement of an intrauterine device or intrauterine system, physical barrier, male sterilisation or true abstinence) until 6 months after the last dose of IP.
5. Must be able to provide informed consent, which must be obtained prior to the procedures related to the transition-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 514
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 70

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 Remicade or SB2
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-/bedbound).
f. History of demyelinating disorders.
Subjects meeting any of the following criteria must not be enrolled in the transition-extension period:
1. Have been withdrawn from the SB2-G31-RA study for any reason.
2. 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.
3. Plan to participate in another study with an investigational product during the transition-extension period.
4. Have been taking or plan to take any biological agents except SB2 and Remicade during the transition-extension period. 5. Are taking or plan to take any of the following concomitant medications during the transition-extension period:
a. Corticosteroids above levels equivalent to 10 mg prednisolone daily, for RA treatment.
b. Any DMARDs/systemic immunosuppressive agents, other than MTX, including hydroxy-chloroquine, chloroquine, sulfasalazine, azathioprine, cyclosporine, mycophenolate mofetil, or leflunomide.
c. Alkylating agents.
d. Live or live-attenuated vaccine.