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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT01936181
Date of registration: 02/09/2013
Prospective Registration: Yes
Primary sponsor: Samsung Bioepis Co., Ltd.
Public title: A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Scientific title: A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
Date of first enrolment: August 2013
Target sample size: 584
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01936181
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  Phase 3
Countries of recruitment
Bulgaria Lithuania
Contacts
Name:     Jung-Yoon Choe, M.D., Ph.D.
Address: 
Telephone:
Email:
Affiliation:  Daegu Catholic University Medical Center
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6
months

- 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 6 months after the last dose of
investigational product

Inclusion Criteria for Transition-Extension Period:

- Have been enrolled and completed the scheduled Week 54 visit of the randomised,
double-blind period of the SB2-G31-RA study

- 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

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
Remicade or SB2

- 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.

Exclusion Criteria for Transition-Extension Period:

- Have been withdrawn from the SB2-G31-RA study for any reason

- 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Remicade (infliximab)
Drug: SB2 (proposed biosimilar to infliximab)
Primary Outcome(s)
American College of Rheumatology 20% Response Criteria (ACR20) [Time Frame: Week 30]
Secondary Outcome(s)
ACR20 [Time Frame: Week 54, Week 78]
American College of Rheumatology 50% Response Criteria (ACR50) [Time Frame: Week 30, Week 54, Week 78]
Disease Activity Score Based on a 28 Joint Count (DAS28) [Time Frame: Week 30, Week 54, Week 78]
Secondary ID(s)
SB2-G31-RA
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 29/08/2016
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT01936181
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