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| A placebo-controlled trial of anti-TNFa chimeric monoclonal antibody (infliximab, remicade) in the modification of vascular disease markers in active rheumatoid arthritis |
| Source of record | UK Trials |
| ISRCTN | ISRCTN29665463 |
| Date ISRCTN assigned | 23/11/2007 |
| Local reference number(s) | RJI 03/0139 |
| Public title | A placebo-controlled trial of anti-TNFa chimeric monoclonal antibody (infliximab, remicade) in the modification of vascular disease markers in active rheumatoid arthritis |
| Scientific title | |
| Acronym | DIVERT - Defining Infliximab Vascular Effects Rheumatoid arthritis Trial |
| Disease/condition/study domain | Rheumatoid Arthritis |
| Study hypothesis | That surrogate measures of vascular disease (pulse wave velocity, flow mediated dilatation, carotid-intimal media thickness), will improve after infliximab therapy in patients with active rheumatoid arthritis. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Guy's Hospital Research Ethics Committee, approved on 28 November 2003 (ref: RJI - 03/0139) |
| Countries of trial | United Kingdom |
| Participants - 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) |
| Participants - 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) |
| Patient information material | |
| Anticipated start date | 15/05/2003 |
| Anticipated end date | 15/05/2005 |
| Status of trial | Completed |
| Target number of participants | 30 |
| 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. |
| Primary outcome measure(s) | 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 outcome measure(s) | 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 |
| Sources of funding | Centocor BV (The Netherlands) |
| Sponsor name | Guy's & St Thomas' NHS Foundation Trust (UK) |
| Sponsor details | R&D Department Connybeare House Guy's Hospital St Thomas Street London United Kingdom SE1 9RT |
| Sponsor email | jackie.pullen@gstt.nhs.uk |
| Sponsor website | http://www.guysandstthomas.nhs.uk/ |
| Contact name | Dr Bruce Kirkham |
| Contact details | Rheumatology Department 4th floor Thomas Guy House Guy's Hospital London United Kingdom SE1 9RT |
| Contact email | bruce.kirkham@gstt.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN29665463 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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