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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7 April 2015 |
Main ID: |
EUCTR2012-005026-30-BG |
Date of registration:
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05/03/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study Comparing SB4 to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
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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 SB4 Compared to Enbrel® in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy |
Date of first enrolment:
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10/04/2013 |
Target sample size:
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596 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005026-30 |
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: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Bulgaria
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Colombia
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Czech Republic
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Hungary
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India
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Korea, Republic of
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Lithuania
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Mexico
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Poland
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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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+1862261 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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+1862261 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 consent form.
2. Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (ACR) criteria
3. Have more than or equal to six swollen joints, more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation and 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). 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 520 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 76
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 Enbrel or SB4.
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-/bed-bound).
f History of demyelinating disorders.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy. The intended use of SB4 is Rheumatoid Arthritis (RA), Juvenile Idiopathic Arthritis (JIA), Psoriatic Arthritis (PsA), Ankylosing Spondylitis (AS), plaque Psoriasis (PsO) and paediatric plaque PsO. MedDRA version: 17.1
Level: SOC
Classification code 10021428
Term: Immune system disorders
System Organ Class: 10021428 - Immune system disorders
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Intervention(s)
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Product Name: SB4 (etanercept biosimilar) Product Code: SB4 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Current Sponsor code: SB4 Other descriptive name: TNFR:Fc Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50-
Trade Name: Enbrel® Product Name: Enbrel® Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ETANERCEPT CAS Number: 185243-69-0 Other descriptive name: TNFR:Fc Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50-
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Primary Outcome(s)
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Primary end point(s): The primary endpoint for the study is the ACR 20 response at Week 24
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Main Objective: The primary objective of this study is to demonstrate the equivalence of SB4 to Enbrel® at Week 24, in terms of American College of Rheumatology 20% response criteria (ACR 20) response rate in subjects with moderate to severe rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
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Secondary Objective: The secondary objectives are: ? To evaluate efficacy of SB4 compared to Enbrel using relevant efficacy endpoints other than ACR 20 at Week 24 in subjects with moderate to severe RA despite MTX therapy ? To evaluate safety and tolerability of SB4 compared to Enbrel in subjects with moderate to severe RA despite MTX therapy ? To evaluate pharmacokinetics of SB4 compared to Enbrel in subjects with moderate to severe RA despite MTX therapy ? To evaluate immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe RA despite MTX therapy
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Timepoint(s) of evaluation of this end point: Week 24
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: ? The ACR 20 response at Week 52
? The ACR 50 response and ACR 70 response at Week 24 and Week 52
? The numeric index of the ACR response (ACR-N) at Week 24 and Week 52
? The area under the curve (AUC) of ACR-N up to Week 24
? The disease activity score based on a 28 joint count (DAS28 score) at Week 24 and Week 52
? The European League Against Rheumatism response at Week 24 and Week 52
? The AUC of the change in DAS28 from Baseline up to Week 24? Major clinical response (ACR 70 response for 6 consecutive months) at Week 52
? Change from baseline in modified Total Sharp Score at Week 52
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Secondary end point(s): The secondary efficacy endpoints are:
? The ACR 20 response at Week 52
? The ACR 50 response and ACR 70 response at Week 24 and Week 52
? The numeric index of the ACR response (ACR-N) at Week 24 and Week 52
? The area under the curve (AUC) of ACR-N up to Week 24
? The disease activity score based on a 28 joint count (DAS28 score) at Week 24 and Week 52
? The European League Against Rheumatism response at Week 24 and Week 52
? The AUC of the change in DAS28 from Baseline up to Week 24? Major clinical response (ACR 70 response for 6 consecutive months) at Week 52
? Change from baseline in modified Total Sharp Score at Week 52
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Secondary ID(s)
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2012-005026-30-HU
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SB4-G31-RA
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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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