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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: 19 February 2018
Main ID:  EUCTR2015-000089-72-IT
Date of registration: 06/02/2015
Prospective Registration: Yes
Primary sponsor: Policlinico Gemelli-CIC- UCSC
Public title: abatacept in obese and overweight RA patiens
Scientific title: FAT GENE EXPRESSION IN OVERWEIGHT AND OBESE PATIENTS WITH PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT AND CLINICAL RESPONSE
Date of first enrolment: 26/03/2015
Target sample size: 40
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-000089-72
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: no
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): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Italy
Contacts
Name: Divisione di Reumatologia   
Address:  Via G. Moscati 31 Rome Italy
Telephone: +39063503654
Email: reumatologia@rm.unicatt.it
Affiliation:  Divisione di Reumatologia- Complesso integrato Columbus UCSC
Name: Divisione di Reumatologia   
Address:  Via G. Moscati 31 Rome Italy
Telephone: +39063503654
Email: reumatologia@rm.unicatt.it
Affiliation:  Divisione di Reumatologia- Complesso integrato Columbus UCSC
Key inclusion & exclusion criteria
Inclusion criteria:
Signed written Informed Consent
- RA patients with disease duration <12 months, in at least a moderately active disease state (DAS28 >3.2) despite MTX at the maximum tolerated doses (10-25 mg/week) and low doses of prednisone (<5 mg daily), stable since at least three months before enrolment (if necessary)
- Age: 18-70 years

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 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion criteria:
Hypersensitivity to the active substance or to any of the excipients
- Severe and uncontrolled infections such as sepsis and opportunistic infections
- Patients who are currently included in any interventional clinical trial in RA
- RA patients in therapy with other biologics



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied

MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: ORENCIA
Product Name: Orencia abatacept
Pharmaceutical Form: Solution for injection

Primary Outcome(s)
Main Objective: The study primary objective is to provide a better understanding of the molecular and cellular pathways involved in abatacept action in overweight and obese RA patients, by showing its effects at the fat tissue level (as well as at the circulating bloodstream levels) on cells, genes, and molecules known to play a role in producing inflammation. In particular, we want to investigate whether overweight and obesity could be associated to a specific adipose tissue and immune system cells gene expression (IL-6, TNF-alpha, BAFF, BAFF-R, PEDF, Chemerin, Sirtuin1, arginase1 and CD11c) and whether their pre-treatment expression could be influenced by abatacept after 6 months of treatment.
Primary end point(s): Changes from baseline in specific adipose tissue and immune system cells gene expression (IL-6, TNF-alpha, BAFF, BAFF-R, PEDF, Chemerin, Sirtuin1, arginase1 and CD11c) after 6 months of treatment.
Secondary Objective: – To assess the percentage of overweight (BMI 25-30 Kg/m2) and obese (BMI >30 Kg/m2) RA patients that reach DAS28 remission after 6 months of abatacept treatment.
– To assess whether there is any relationship between changes of the inflammatory milieu at the fat tissue level and clinical outcomes after abatacept treatment.
Timepoint(s) of evaluation of this end point: 6 months
Secondary Outcome(s)
Secondary end point(s): Percentage of overweight and obese RA patients in DAS28 remission at 6 months.
- Correlation between clinical response to treatment and changes at the fat tissue and circulating bloodstream levels after abatacept
Timepoint(s) of evaluation of this end point: 6 months
Secondary ID(s)
204
Source(s) of Monetary Support
Azienda Farmaceutica
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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