abatacept in obese and overweight RA patiens

Phase 1

• Conditions: MedDRA version: 17.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2015-000089-72-IT
• Lead Sponsor: Policlinico Gemelli-CIC- UCSC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-06
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified