Main
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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:
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EUCTR |
Last refreshed on:
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28 August 2017 |
Main ID: |
EUCTR2012-005733-37-BG |
Date of registration:
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21/05/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study Comparing SB2 to Remicade® in Subjects with Moderate to Severe Rheumatoid Arthritis
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Scientific title:
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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:
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10/07/2013 |
Target sample size:
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584 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005733-37 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Remicade
Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Bosnia and Herzegovina
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Bulgaria
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Czech Republic
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India
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Korea, Republic of
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Latvia
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Lithuania
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Mexico
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Philippines
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Poland
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Romania
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Ukraine
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United Kingdom
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Contacts
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Name:
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Quintiles Contact Centre
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Address:
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The Alba Campus, Rosebank
EH54 7EG
Livingston
United Kingdom |
Telephone:
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+1 862 261 3634 |
Email:
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Affiliation:
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Quintiles Limited |
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Name:
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Quintiles Contact Centre
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Address:
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The Alba Campus, Rosebank
EH54 7EG
Livingston
United Kingdom |
Telephone:
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+1 862 261 3634 |
Email:
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Affiliation:
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Quintiles Limited |
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Key inclusion & exclusion criteria
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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 obtaine
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.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis MedDRA version: 17.0
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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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 Sponsor code: SB2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Trade Name: Remicade® Product Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Week 30
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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.
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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.
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Primary end point(s): The primary endpoint for the study is the ACR20 response at Week 30
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Secondary Outcome(s)
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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
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Timepoint(s) of evaluation of this end point: Weeks 30 and 54
For the transition-extension period week 78.
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Secondary ID(s)
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SB2-G31-RA
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2012-005733-37-CZ
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Source(s) of Monetary Support
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Samsung Bioepis Co., Ltd.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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