An Observational and Exploratory Study to determine the effect of anti TNF Biologic Treatment in Rheumatoid Cachexia

Phase 1

• Conditions: Cachexia in patients with Rheumatoid arthritis.; MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis

• Registration Number: EUCTR2006-006562-42-GB
• Lead Sponsor: Derby Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-01-13
• Study Completion: 2011-08-01
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 32

Inclusion Criteria

Patients with Rheuamtoid Arthritis as defined by the 1987 Revised ARA Criteria for the classification of Rheumatoid Arthritis

Patients meeting the NICE criteria for prescription of anti-TNF therapy

Patients who are prescribed Etanercept treatment with or without methotrextat
=25mg/week oral or subcutaneous

Men and women aged more than 18 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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study in accordance with the contraindications that appear in the SmPC

Subjects aged less than 18 years
Participation in other research studies that might be in conflict with this study.

Neuromuscular disease

Anti-TNF therapy other than Etanercept

Continuous oral corticosteroids for > 12 weeks prior to baseline

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the effect of biologic treatment (anti-TNF therapy - Etanercept) on muscle mass in patients with Rheumatoid Arthritis;Secondary Objective: To determine the effect of anti TNF therapy, Etanercept on fat mass and distribution, in patients with rheumatoid arthritis.;Primary end point(s): The primary end point of the study is measurement of peripheral lean body mass (non fat, non bone mass ) by DXA scan and comparing it with the baseline measurement