abatacept in obese and overweight RA patiens

FAT GENE EXPRESSION IN OVERWEIGHT AND OBESE PATIENTS WITH PERSISTENTLY ACTIVE RHEUMATOID ARTHRITIS TREATED WITH ABATACEPT AND CLINICAL RESPONSE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000089-72-IT

Enrollment

Registered

2015-02-06

Start date

2015-03-26

Completion date

Unknown

Last updated

2018-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 17.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Signed written Informed Consent - RA patients with disease duration 3.2) despite MTX at the maximum tolerated doses (10-25 mg/week) and low doses of prednisone (=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.;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. ;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.;Timepoint(s) of evaluation of this end point: 6 months	—

Measure

Time frame

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.;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. ;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.;Timepoint(s) of evaluation of this end point: 6 months

—

Secondary

Measure	Time frame
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	—

Countries

Italy

Contacts

Public ContactDivisione di Reumatologia

Divisione di Reumatologia- Complesso integrato Columbus UCSC

reumatologia@rm.unicatt.it+39063503654

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026