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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: 7 January 2019
Main ID:  EUCTR2015-002491-24-DE
Date of registration: 30/03/2016
Prospective Registration: Yes
Primary sponsor: Universitätsklinikum Freiburg, vertreten durch den Leitenden Ärztlichen Direktor
Public title: Safety of Abatacept in patients with interstitial lung disease and common variable immunodeficiency (CVID) and related disease
Scientific title: Safety of Abatacept in patients with interstitial lung disease and common variable immunodeficiency (CVID) and related disease - SAIL
Date of first enrolment: 11/05/2016
Target sample size: 10
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-002491-24
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Germany
Contacts
Name: Clinical Trials unit   
Address:  Elsässerstr. 2 79106 Freiburg Germany
Telephone: +490761270-74040
Email: sabine.schneider-fuchs@uniklinik-freiburg.de
Affiliation:  University Medical Center Freiburg
Name: Clinical Trials unit   
Address:  Elsässerstr. 2 79106 Freiburg Germany
Telephone: +490761270-74040
Email: sabine.schneider-fuchs@uniklinik-freiburg.de
Affiliation:  University Medical Center Freiburg
Key inclusion & exclusion criteria
Inclusion criteria:
1. Diagnosis of CVID according to ESID/PAGID criteria or diagnosis of related disorders which fulfill the diagnostic criteria for CVID
2. Interstitial lung disease or granuloma diagnosed by chest CT positive for nodules, lines or ground-glass signs
3. Age 18 years and above
4. Signed written informed consent
5. Not responsive to steroid monotherapy for a minimum of three months or intolerance of steroid therapy
6. Need for intervention measured by either reduced oxygen saturation, drop of oxygen saturation under exercise or reduced DLCOcSB
OR
progress of interstitial lung disease measured by progressive changes in the CT scan of the lung

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 7
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion criteria:
1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the study
2. Other immunosuppressive therapy including biologicals beyond steroid at screening phase
3. Previous treatment with Abatacept
4. Active Hepatitis B infection or tuberculosis infection
5. Other Uncontrolled infection
6. Lymphoma within the past 5 years
7. Pregnancy indicated by positive urine pregnancy test at screening
8. Breast feeding patients
9. Fertile patients refusing to use safe contraceptive methods during the study
10. Simultaneous participation in other interventional clinical trials



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
CVID patients confirmed according to ESID/PAGID criteria or related disorders which fulfill the diagnostic criteria for CVID and interstitial lung disease or granuloma diagnosed by chest CT positive for nodules, lines or ground-glass signs
MedDRA version: 18.1 Level: PT Classification code 10022611 Term: Interstitial lung disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 18.1 Level: PT Classification code 10021449 Term: Immunodeficiency common variable System Organ Class: 10021428 - Immune system disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: ORENCIA® 125 mg solution for injection in pre-filled syringe
Product Name: Abatacept
Product Code: BMS-188667
Pharmaceutical Form: Solution for injection in pre-filled syringe

Primary Outcome(s)
Main Objective: To assess the safety of Abatacept for interstitial lung disease in patients with CVID and related disorders
Primary end point(s): (1) Number and type of severe infections (intravenous treatment, hospitalization, ICU, opportunistic infection, death) under treatment
(2) Number, type and severity of all other (serious) adverse events ((S)AE) in relation to study drug
Secondary Objective: To assess the efficacy of Abatacept on interstitial lung disease in patients with CVID and related disorders
Timepoint(s) of evaluation of this end point: (1) 12 months retrospective documentation before BaselineVisit (Day 0), BaselineVisit (Day 0), 3 months (Visit 1), 6 months (Visit 2), 12 months (Final Visit)
(2) during screening up to 3 months before BaselineVisit (Day 0), BaselineVisit (Day 0), 3 months (Visit 1), 6 months (Visit 2), 12 months (Final Visit), 13 months (Follow-up via phone call)
Secondary Outcome(s)
Secondary end point(s): (1) Lung function parameters (DLCOcSB, FVC, DLCOc/VA, TLC SB, Predicted forced expiratory volume in one second FEV1 [L])
(2) pO2 at rest and under exercise (six minute walking test)
(3) Laboratory parameters: sIL-2-receptor, Neopterin
(4) CT scan lung: Global and specific score for nodules, lines, consolidation and ground glass
(5) Cumulative steroid dose
(6) Quality of life measured by SF36, CRDQ and SGRQ
(7) Overall Survival
(8) Immune phenotype of B- and T-cells
Timepoint(s) of evaluation of this end point: (1), (2, pO2 at rest), (3): 12 months retrospective documentation before BaselineVisit (Day 0), BaselineVisit (Day 0), 3 months (Visit 1), 6 months (Visit 2), 12 months (Final Visit)
(2) pO2 under exercise: 12 months retrospective documentation before BaselineVisit (Day 0), BaselineVisit (Day 0), 12 months (Final Visit)
(4) 12 months retrospective documentation before BaselineVisit (Day 0), BaselineVisit (Day 0), 12 months (Final Visit)
(5) BaselineVisit (Day 0), 3 months (Visit 1), 6 months (Visit 2), 12 months (Final Visit)
(6) SF36: BaselineVisit (Day 0), 12 months (Final Visit);
CRDQ and SGRQ: BaselineVisit (Day 0), 6 months (Visit 2), 12 months (Final Visit)
(7) All visits
(8) BaselineVisit (Day 0), 12 months (Final Visit)
Secondary ID(s)
BMS-IM101-563
DRKS00008783
Source(s) of Monetary Support
Bristol-Myers Squibb GmbH und Co. KG
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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