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Trial record 47 of 1665 for:    ( Map: Bulgaria )

A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

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ClinicalTrials.gov Identifier: NCT01936181
Recruitment Status : Completed
First Posted : September 5, 2013
Results First Posted : August 29, 2016
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
Samsung Bioepis Co., Ltd.

Brief Summary:
This is a randomized, 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 (RA) despite Methotrexate (MTX) therapy.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Remicade (infliximab) Drug: SB2 (proposed biosimilar to infliximab) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 584 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: SB2 (proposed biosimilar to inflixmab)
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
Drug: SB2 (proposed biosimilar to infliximab)
Active Comparator: Remicade (infliximab)
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
Drug: Remicade (infliximab)
Experimental: Remicade (infliximab), switch to SB2
SB2 3mg/kg at week 54, 62, 70
Drug: SB2 (proposed biosimilar to infliximab)
Active Comparator: Remicade (infliximab), continue as Remicade
Remicade 3mg/kg at week 54, 62, 70
Drug: Remicade (infliximab)



Primary Outcome Measures :
  1. American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 30 ]

Secondary Outcome Measures :
  1. ACR20 [ Time Frame: Week 54, Week 78 ]
  2. American College of Rheumatology 50% Response Criteria (ACR50) [ Time Frame: Week 30, Week 54, Week 78 ]
  3. Disease Activity Score Based on a 28 Joint Count (DAS28) [ Time Frame: Week 30, Week 54, Week 78 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01936181


Locations
Bulgaria
Investigational Site
Hristo Botev Str., Sliven, Bulgaria, 8800
Lithuania
Investigational Site
Santariskiu, Vilnius, Lithuania, 08661
Sponsors and Collaborators
Samsung Bioepis Co., Ltd.
Investigators
Principal Investigator: Jung-Yoon Choe, M.D., Ph.D. Daegu Catholic University Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samsung Bioepis Co., Ltd.
ClinicalTrials.gov Identifier: NCT01936181     History of Changes
Other Study ID Numbers: SB2-G31-RA
First Posted: September 5, 2013    Key Record Dates
Results First Posted: August 29, 2016
Last Update Posted: September 14, 2017
Last Verified: August 2017

Keywords provided by Samsung Bioepis Co., Ltd.:
Rheumatoid Arthritis
Infliximab
Biosimilar

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Gastrointestinal Agents