Condition category
Circulatory System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
21/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr David D'Cruz

ORCID ID

Contact details

Louise Coote Lupus Unit
Ground Floor
Gassiot House
St. Thomas' Hospital
Lambeth Palace Road
London
SE1 7EH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013129680

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

04/06/2003

Overall trial end date

31/05/2006

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

40

Participant 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.

Recruitment start date

04/06/2003

Recruitment end date

31/05/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Louise Coote Lupus Unit
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17360788

Publication citations

  1. Results

    Sangle SR, Hughes GR, D'Cruz DP, Infliximab in patients with systemic vasculitis that is difficult to treat: poor outcome and significant adverse effects., Ann. Rheum. Dis., 2007, 66, 4, 564-565, doi: 10.1136/ard.2006.065623.

Additional files

Editorial Notes