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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31 August 2020 |
Main ID: |
EUCTR2016-001948-19-SE |
Date of registration:
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19/10/2016 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome
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Scientific title:
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A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sjögrens Syndrome |
Date of first enrolment:
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02/02/2017 |
Target sample size:
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288 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001948-19 |
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: yes Other: no 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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Argentina
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Australia
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Brazil
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Canada
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Czech Republic
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Denmark
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France
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Germany
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Italy
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Japan
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Korea, Republic of
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Mexico
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Norway
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Sweden
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Contacts
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Name:
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GCT-SU
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Address:
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Parc de l'Alliance - Avenue de Finlande, 4
1420
Braine-l'Alleud
Belgium |
Telephone:
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Email:
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clinical.trials@bms.com |
Affiliation:
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Bristol-Myers Squibb International Corporation |
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Name:
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GCT-SU
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Address:
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Parc de l'Alliance - Avenue de Finlande, 4
1420
Braine-l'Alleud
Belgium |
Telephone:
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Email:
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clinical.trials@bms.com |
Affiliation:
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Bristol-Myers Squibb International Corporation |
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Key inclusion & exclusion criteria
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Inclusion criteria: - ESSDAI score of at least 5
- Positive anti-SS-A/Ro antibody at screening
- Meet the proposed 2015 ACR/EULAR Classification Criteria for Sjögren’s Syndrome 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 287 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria: - Secondary sjogrens syndrome
- Active life-threatening or organ-threatening complications of Sjögren’s-syndrome
- Other medical condition associated with sicca syndrome
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Immune System Diseases [C20]
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Adults with moderately to severely Active Primary Sjögrens Syndrome MedDRA version: 20.0
Level: LLT
Classification code 10040766
Term: Sjogren's disease
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0
Level: PT
Classification code 10040767
Term: Sjogren's syndrome
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0
Level: LLT
Classification code 10042846
Term: Syndrome Sjogren's
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.0
Level: LLT
Classification code 10040765
Term: Sjogren's
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 20.1
Level: PT
Classification code 10048676
Term: Sjogren-Larsson syndrome
System Organ Class: 10010331 - Congenital, familial and genetic disorders
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Intervention(s)
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Trade Name: Orencia Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ABATACEPT CAS Number: 332348-12-6 Current Sponsor code: BMS-188667 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Main Objective: The Primary Objective of this study is to compare the mean change from baseline (Day 1) to Day 169 in ESSDAI of abatacept versus placebo in subjects with moderate to severe pSS
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Primary end point(s): The mean change from baseline (Day 1) to Day 169 in ESSDAI
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Timepoint(s) of evaluation of this end point: 6 months
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Secondary Objective: - To compare the mean change from baseline (Day 1) to Day 169 in EULAR Sjögren’s Syndrome Patient Reported Index (ESSPRI) of abatacept versus placebo in subjects with moderate to severe pSS. - To compare the mean changes from baseline (Day 1) to Day 169 in the stimulated whole salivary flow of abatacept versus placebo in subjects with residual stimulated whole salivary flow of at least 0.1 mL/min at baseline.
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Secondary Outcome(s)
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Secondary end point(s): - The change from baseline (Day 1) to Day 169 in ESSPRI
- The change from baseline (Day 1) in the stimulated whole salivary flow to Day 169 among subjects with stimulated whole salivary flow of at least 0.1 mL/min
- Proportion of subjects with a least one positive immunogenicity response )
- Safety (proportion of subjects with adverse events, deaths, SAEs, and AEs leading to discontinuation and proportion of laboratory marked abnormalities) up to Day 169 and during the cumulative abatacept period and follow-up period
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Timepoint(s) of evaluation of this end point: - Day 1 to Day 169
- Day 1 to Day 169
- Day 1 to 168 days after the last dose of study drug
- Day 1 to 168 days after the last dose of study drug
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Secondary ID(s)
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IM101-603
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Source(s) of Monetary Support
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Bristol-Myers Squibb International Corporation
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Ethics review
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Status: Approved
Approval date: 02/02/2017
Contact:
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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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