A placebo-controlled trial of anti-TNFa chimeric monoclonal antibody (infliximab, remicade) in the modification of vascular disease markers in active rheumatoid arthritis
| ISRCTN | ISRCTN29665463 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29665463 |
| Secondary identifying numbers | RJI 03/0139 |
- Submission date
- 05/03/2007
- Registration date
- 23/11/2007
- Last edited
- 14/06/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Bruce Kirkham
Scientific
Scientific
Rheumatology Department
4th floor
Thomas Guy House
Guy's Hospital
London
SE1 9RT
United Kingdom
| bruce.kirkham@gstt.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DIVERT - Defining Infliximab Vascular Effects Rheumatoid arthritis Trial |
| 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. |
| Ethics approval(s) | Guy's Hospital Research Ethics Committee, approved on 28 November 2003 (ref: RJI - 03/0139) |
| Condition | Rheumatoid Arthritis |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | infliximab |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 15/05/2003 |
| Overall study end date | 15/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Participant 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) |
| Participant 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) |
| Recruitment start date | 15/05/2003 |
| Recruitment end date | 15/05/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Rheumatology Department
London
SE1 9RT
United Kingdom
SE1 9RT
United Kingdom
Sponsor information
Guy's & St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
R&D Department
Connybeare House
Guy's Hospital
St Thomas Street
London
SE1 9RT
England
United Kingdom
| jackie.pullen@gstt.nhs.uk | |
| Website | http://www.guysandstthomas.nhs.uk/ |
"ROR" |
https://ror.org/00j161312 |
Funders
Funder type
Industry
Centocor BV (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2009 | Yes | No |
