A randomised controlled trial of Infliximab in ANCA associated systemic vasculitis.
| ISRCTN | ISRCTN76658104 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76658104 |
| Secondary identifying numbers | N0013129680 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 21/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David D'Cruz
Scientific
Scientific
Louise Coote Lupus Unit
Ground Floor, Gassiot House
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | To confirm that TNF a levels are elevated and correlate with disease activity in our cohort of vasculitis patients. To study the efficacy of infliximab in the treatment of ANCA associated vasculitis resistant to conventional immunosuppressive therapy. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular: Systemic vasculitis |
| Intervention | This is a randomised controlled trial comparing Infliximab and placebo. Patients will receive either a single infusion of infliximab (5mg/kg) or placebo and will be followed for 3 months. Patients will continue to receive their current immunosuppressive therapy. Birmingham Vasculitis activity score (BVAS) will be used to judge the response. The responders will continue to receive infliximab (5mg/kg) infusion at 6, 14, 22 and 26 weeks. |
| Intervention type | Other |
| Primary outcome measure | Response will be judged by 50% reduction in BVAS score, CRP, ESR, patient and physician global score, reduction in prednisolone and concomitant immunosuppressive therapy. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 04/06/2003 |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 40 |
| Key inclusion criteria | There are no previously published studies of infliximab in systemic vasculitis. However, a similar study of IVIG demonstrated a 50% reduction in disease activity after 3 months in a total of 34 patients (17 each in active and placebo group). Therefore in order to give a similar power of 0.8, we plan to recruit 40 patients (20 patients in each group) to give a significance level of 0.05 in a two-tailed study. Randomization will be done with minimisation protocol to ensure patients with similar characteristics in each group. |
| Key exclusion criteria | 1. Positive pregnancy test or a planned pregnancy during treatment with infliximab or within 6 months of the last infusion 2. Prior administration of REMICADE or any other therapeutic agent targeted at reducing TNF (e.g., Etanercept, pentoxifylline, thalidomide or anti-CD4+ antibody) within the previous 3 months 3. A history of known allergies to murine proteins 4. Rapidly progressive glomerulonephritis 5. Severe pulmonary haemorrhage 6. History of Chronic/Serious infections, such as pneumonia, pyelonephritis and bacterial peritonitis in the previous 3 months. Less serious infections in the previous 3 months, such as acute upper respiratory tract infection (colds) or uncomplicated urinary tract infection if not fully resolved need not be considered exclusions at the discretion of the treating physician. 7. History of opportunistic infections such as herpes zoster within 2 months of screening. Evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium, etc. 8. Severe and/or chronic renal / pulmonary infections or sinusitis in the last 3 months 9. Known active tuberculosis requiring treatment during the last 3 years. 10. Documented HIV infection. 11. Any history of other autoimmune diseases. 12. Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease. 13. Known lymphoproliferative disease including lymphoma or signs suggestive of lymphoproliferative disease such as lymphadenoma of unusual size and localization or splenomegaly. 14. Any currently known malignancy or pre-malignant lesions or any history of malignancy within the past five years. |
| Date of first enrolment | 04/06/2003 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Louise Coote Lupus Unit
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
Guy's and St. Thomas' NHS Foundation Trust (UK)
No information available
Own account
No information available
NHS R&D Support Funding
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 | 01/04/2007 | Yes | No |
