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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-006562-42-GB

Enrollment

Registered

2009-01-13

Start date

2008-02-21

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

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

Interventions

Trade Name: Enbrel Product Name: Etanercept 50mg Pharmaceutical Form: Powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

United Kingdom

Outcome results

None listed

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