A placebo-controlled trial of anti-TNFa chimeric monoclonal antibody (infliximab, remicade) in the modification of vascular disease markers in active rheumatoid arthritis

Completed

• Conditions: Rheumatoid Arthritis; Musculoskeletal Diseases

• Registration Number: ISRCTN29665463
• Lead Sponsor: Guy's & St Thomas' NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-23
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. RA defined by American College of Rheumatology criteria
2. Referred for TNF-blocking therapy according to the British Society of Rheumatology (BSR) criteria
3. Patients giving written informed consent
4. Patients failed two DMARDs including methotrexate
5. Disease Activity Score 28 (DAS 28) greater than 5.1 on two occasions four weeks apart
6. Patients taking methotrexate (<=25 mg/week)

Exclusion Criteria

1. Age <18 years
2. History of ischemic heart disease, cerebrovascular disease, peripheral vascular disease, diabetes mellitus
3. Previous treatment with infliximab or any therapeutic agent targeted at reducing TNFa
4. Treatment with aspirin
5. Patients with evidence of current or previous infection with tuberculosis (TB)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following will be assessed at baseline (Week 0), Week 24 and Week 56, unless indicated otherwise: <br>1. Endothelial function (Flow Mediated Dilatation [FMD]). This will be assessed at Week 8 and Week 16 in addition to the timepoints stated above. <br>2. Vascular structure: <br>2.1. Pulse Wave Velocity [PWV] <br>2.2. Augmentation Index [Aix] <br>2.3. Carotid Intimal Medial Thickening [CIMT]