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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: EUCTR
Last refreshed on: 15 June 2020
Main ID:  EUCTR2016-001948-19-FR
Date of registration: 07/11/2016
Prospective Registration: Yes
Primary sponsor: Bristol-Myers Squibb International Corporation
Public title: A Study to Assess the Efficacy and Safety of Abatacept in Adults with Active Primary Sjögrens Syndrome
Scientific title: 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: 02/12/2016
Target sample size: 288
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-001948-19
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no
Countries of recruitment
Argentina Australia Brazil Canada Czech Republic Denmark France Germany
Italy Japan Korea, Republic of Mexico Norway Sweden
Contacts
Name: GCT-SU   
Address:  Parc de l'Alliance - Avenue de Finlande, 4 1420 Braine-l'Alleud Belgium
Telephone:
Email: clinical.trials@bms.com
Affiliation:  Bristol-Myers Squibb International Corporation
Name: GCT-SU   
Address:  Parc de l'Alliance - Avenue de Finlande, 4 1420 Braine-l'Alleud Belgium
Telephone:
Email: clinical.trials@bms.com
Affiliation:  Bristol-Myers Squibb International Corporation
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Adults with moderately to severely Active Primary Sjögrens Syndrome
MedDRA version: 19.0 Level: LLT Classification code 10040766 Term: Sjogren's disease System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0 Level: PT Classification code 10040767 Term: Sjogren's syndrome System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0 Level: LLT Classification code 10042846 Term: Syndrome Sjogren's System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0 Level: LLT Classification code 10040765 Term: Sjogren's System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
MedDRA version: 19.0 Level: PT Classification code 10048676 Term: Sjogren-Larsson syndrome System Organ Class: 10010331 - Congenital, familial and genetic disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

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

Primary Outcome(s)
Main Objective: The Primary Objective of the 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
Primary end point(s): The mean change from baseline (Day 1) to Day 169 in ESSDAI
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.
Timepoint(s) of evaluation of this end point: 6 months
Secondary Outcome(s)
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
Timepoint(s) of evaluation of this end point: - Day 1 to Day 169
- Day 1 to Day 169
- Day 1 to 84 days after the last dose of study drug
- Day 1 to 56 days after the last dose of study drug
Secondary ID(s)
2016-001948-19-SE
IM101-603
Source(s) of Monetary Support
Bristol-Myers Squibb International Corporation
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 02/12/2016
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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