A prospective randomised placebo controlled trial of treatment for fibrosing alveolitis in scleroderma
| ISRCTN | ISRCTN91217042 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91217042 |
| Secondary identifying numbers | D0554 |
- 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
Professor 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
| 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 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, azathioprine and prednisolone |
| Primary outcome measure | 1. Change in percent predicted Forced Vital Capacity (FVC) 2. Change in single-breath diffusing capacity for carbon monoxide (DLCO) |
| Secondary outcome measures | 1. Changes in appearance on high-resolution computed tomography 2. Change in dyspnoea scores |
| Overall study start date | 01/10/1998 |
| Completion date | 31/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Royal Brompton Hospital
London
SW3 6MP
United Kingdom
SW3 6MP
United Kingdom
Sponsor information
Arthritis Research Campaign (ARC) (UK)
Charity
Charity
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
| info@arc.org.uk | |
| Website | http://www.arc.org.uk |
"ROR" |
https://ror.org/02jkpm469 |
Funders
Funder type
Charity
Arthritis Research Campaign (UK)
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 | 01/12/2006 | Yes | No |
