Study of alternative regimens of high dose induction therapy for systemic vasculitis
| ISRCTN | ISRCTN30771772 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30771772 |
| Protocol serial number | B0697 |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Funder | Arthritis Research Campaign (UK) |
- Submission date
- 05/02/2002
- Registration date
- 05/02/2002
- Last edited
- 19/05/2014
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof PA Bacon
Scientific
Scientific
Department of Rheumatology
Division of Immunity & Infection
University of Birmingham Medical School
Edgbaston
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)121 414 6778 |
|---|---|
| p.a.bacon@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Hi Cy3 |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Systemic vasculitis |
| Intervention | At entry the patients will be randomised to either: 1. The HiCy3 regime (six tapering pulses of cyclophosphamide over 3.5 months, with the first pulse being 1.6 g/m^2) 2. The spCy regime - standard pulse cyclophosphamide (nine pulses of 15 mg/kg over 6 months) All patients will receive intravenous methyl prednisolone with each cyclophosphamide pulse plus relatively low dose routine oral steroid. All patients will also receive mesna with each cyclophosphamide pulse, and will progress to a low dose azathioprine consolidation regime, given up to the end of month 18 of total study. Updated 19/05/2014: this trial was stopped for reasons of poor recruitment in 2009. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, methyl prednisolone, mesna, azathioprine |
| Primary outcome measure(s) | Not provided at time of registration |
| Key secondary outcome measure(s) | Not provided at time of registration |
| Completion date | 30/08/2006 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Patients with newly diagnosed systemic vasculitis 2. Patients with a major recent flare and total previous dose of cyclophosphamide less than 70 g |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/02/2001 |
| Date of final enrolment | 30/08/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Rheumatology
Birmingham
B15 2TT
United Kingdom
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
