Rheumatoid Arthritis MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: SB2 (infliximab biosimilar)
Product Code: SB2
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponso
Sponsors
Samsung Bioepis Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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 2 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: The secondary objectives are: 1. To evaluate the efficacy of SB2 compared to Remicade using relevant efficacy endpoints other than ACR20 at Week 30 in subjects with moderate to severe RA despite MTX therapy 2. To evaluate the safety and tolerability of SB2 compared to Remicade in subjects with moderate to severe RA despite MTX therapy 3. To evaluate the pharmacokinetics of SB2 compared to Remicade in subjects with moderate to severe RA despite MTX therapy 4. To evaluate the immunogenicity of SB2 compared to Remicade in subjects with moderate to severe RA despite MTX therapy The secondary objectives for the transition extension period are: To evaluate the safety, tolerability, immunogenicity and efficacy in subjects with RA who transitioned to SB2 from Remicade compared to subjects who maintained Remicade from the randomised, double-blind period.;Primary end point(s): The primary endpoint for the study is the ACR20 response at Week 30;Timepoint(s) of evaluation of this end point: Week 30;Main Objective: The primary objective of this study is to demonstrate the equivalence of SB2 to Remicade at Week 30, in terms of the American College of Rheumatology 20% response criteria (ACR20) response rate in subjects with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Weeks 30 and 54 For the transition-extension period week 78.;Secondary end point(s): The secondary efficacy endpoints are: 1. The ACR20 response at Week 54 2. The ACR 50% response criteria (ACR50) and ACR 70% response criteria (ACR70) response at Week 30 and Week 54 3. The numeric index of the ACR response (ACR-N) at Week 30 and Week 54 4. The area under the curve (AUC) of ACR-N up to Week 30 5. The disease activity score based on a 28 joint count (DAS28 score) at Week 30 and Week 54 6. The European League Against Rheumatism response at Week30 and Week 54 7. The AUC of the change in DAS28 from Baseline up to Week 30 8. Major clinical response (ACR70 response for 6 consecutive months) at Week 54 9. Change from Baseline in modified Total Sharp Score (mTSS) at Week 54 Secondary endpoints for the transition-extension period: The safety endpoints are: • Incidence of SAEs • Incidence of AEs (graded as mild, moderate, severe) • Incidence of clinical laboratory abnormalities • Vital signs abnormalities The immunogenicity endpoints are: • Incidence of anti-drug antibodies • Incidence of neutralising antibodies The efficacy endpoints are: • The ACR20, ACR50 and ACR70 response • Continuous ACR-N • The change in DAS28 score from Week 0 • The EULAR response | — |
Countries
Bosnia and Herzegovina, Bulgaria, Czech Republic, India, Korea, Republic of, Latvia, Lithuania, Mexico, Philippines, Poland, Romania, Ukraine, United Kingdom
Contacts
Public ContactQuintiles Contact Centre
Quintiles Limited
Outcome results
None listed