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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN29665463

Enrollment

Registered

2007-11-23

Start date

2003-05-15

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Rheumatoid Arthritis Musculoskeletal Diseases Rheumatoid Arthritis

Interventions

Placebo controlled 2:1 randomisation, active infliximab (3 mg/kg intravenous) vs placebo infusion for 26 weeks, then open label until week 56, with placebo escape arm at week 14.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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)

Design outcomes

Primary

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

Secondary

Measure	Time frame
The following will be assessed at baseline (Week 0), Week 24 and Week 56, unless indicated otherwise: 1. RA disease activity: 1.1. Modified Health Assessment Questionnaire (HAQ). This will be assessed at Week 8 and Week 16 in addition to the timepoints stated above. 1.2. 28 swollen and tender joint counts. This will be assessed at Week 8 and Week 16 in addition to the timepoints stated above. 1.3. Erythrocyte Sedimentation Rate (ESR) 1.4. Patient Global Assessment (PGA) using a 100 mm visual 1.5. Analogue scale and Disease Activity Score 28 (DAS 28). This will be assessed at Week 8 and Week 16 in addition to the timepoints stated above. 2. CV risk factors: 2.1. Systolic and diastolic Blood Pressure (BP) 2.2. Body Mass Index (BMI) 2.3. High sensitivity C-Reactive Protein (HsCRP) 2.4. Serum fasting lipid profile (total cholesterol, High and Low Density Lipoprotein fractions [HDL, LDL] and triglycerides) 2.5. Oxidised LDL sub-fractions 2.6. Insulin resistance measured by log homeostasis model assessment (HOMA) 2.7. Serum levels of soluble Intracellular Adhesion Molecules (ICAM) 2.8. Vascular Cell Adhesion Molecules (VCAM) and adiponectin	—

Measure

Time frame

The following will be assessed at baseline (Week 0), Week 24 and Week 56, unless indicated otherwise: 1. RA disease activity: 1.1. Modified Health Assessment Questionnaire (HAQ). This will be assessed at Week 8 and Week 16 in addition to the timepoints stated above. 1.2. 28 swollen and tender joint counts. This will be assessed at Week 8 and Week 16 in addition to the timepoints stated above. 1.3. Erythrocyte Sedimentation Rate (ESR) 1.4. Patient Global Assessment (PGA) using a 100 mm visual 1.5. Analogue scale and Disease Activity Score 28 (DAS 28). This will be assessed at Week 8 and Week 16 in addition to the timepoints stated above. 2. CV risk factors: 2.1. Systolic and diastolic Blood Pressure (BP) 2.2. Body Mass Index (BMI) 2.3. High sensitivity C-Reactive Protein (HsCRP) 2.4. Serum fasting lipid profile (total cholesterol, High and Low Density Lipoprotein fractions [HDL, LDL] and triglycerides) 2.5. Oxidised LDL sub-fractions 2.6. Insulin resistance measured by log homeostasis model assessment (HOMA) 2.7. Serum levels of soluble Intracellular Adhesion Molecules (ICAM) 2.8. Vascular Cell Adhesion Molecules (VCAM) and adiponectin

—

Countries

United Kingdom

Outcome results

None listed

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