A prospective randomised placebo controlled trial of treatment for fibrosing alveolitis in scleroderma
| ISRCTN | ISRCTN91217042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91217042 |
| Protocol serial number | D0554 |
| Sponsor | Arthritis Research Campaign (ARC) (UK) |
| Funder | Arthritis Research Campaign (UK) |
- Submission date
- 15/07/2002
- Registration date
- 15/07/2002
- Last edited
- 03/10/2007
- 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 of protocol
Not provided at time of registration
Contact information
Prof RM duBois
Scientific
Scientific
Royal Brompton Hospital
Sydney Street
London
SW3 6MP
United Kingdom
| Phone | +44 (0)20 7351 8327 |
|---|---|
| r.dubois@rbh.nthames.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | FAST study |
| Study objectives | Does routine treatment with cyclophosphamide, azathioprine and prednisolone improve outcomes in fibrosing alveolitis associated with scleroderma? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Fibrosing alveolitis in scleroderma |
| Intervention | Intravenous cyclophosphamide plus prednisolone for 6 months followed by azathioprine for 2.5 years or placebo for all drugs |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, azathioprine and prednisolone |
| Primary outcome measure(s) |
1. Change in percent predicted Forced Vital Capacity (FVC) |
| Key secondary outcome measure(s) |
1. Changes in appearance on high-resolution computed tomography |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 45 |
| Key inclusion criteria | 1. Aged 18 - 75 years 2. American College of Rheumatology (ACR) criteria for scleroderma 3. Evidence for fibrosing alveolitis - High Resolution Computed Tomography (HRCT) or surgical biopsy |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/1998 |
| Date of final enrolment | 31/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Royal Brompton Hospital
London
SW3 6MP
United Kingdom
SW3 6MP
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/12/2006 | Yes | No |
