Condition category
Musculoskeletal Diseases
Date applied
15/07/2002
Date assigned
15/07/2002
Last edited
03/10/2007
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

Professor RM duBois

ORCID ID

Contact details

Royal Brompton Hospital
Sydney Street
London
SW3 6MP
United Kingdom
+44 (0)20 7351 8327
r.dubois@rbh.nthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

D0554

Study information

Scientific title

Acronym

FAST study

Study hypothesis

Does routine treatment with cyclophosphamide, azathioprine and prednisolone improve outcomes in fibrosing alveolitis associated with scleroderma?

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

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 names

Cyclophosphamide, azathioprine and prednisolone

Primary outcome measures

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 trial start date

01/10/1998

Overall trial end date

31/10/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

45

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/1998

Recruitment end date

31/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton Hospital
London
SW3 6MP
United Kingdom

Sponsor information

Organisation

Arthritis Research Campaign (ARC) (UK)

Sponsor details

Copeman House
St Mary's Court
St Mary's Gate
Chesterfield
Derbyshire
S41 7TD
United Kingdom
-
info@arc.org.uk

Sponsor type

Charity

Website

http://www.arc.org.uk

Funders

Funder type

Charity

Funder name

Arthritis Research Campaign (UK)

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

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17133610

Publication citations

  1. Results

    Hoyles RK, Ellis RW, Wellsbury J, Lees B, Newlands P, Goh NS, Roberts C, Desai S, Herrick AL, McHugh NJ, Foley NM, Pearson SB, Emery P, Veale DJ, Denton CP, Wells AU, Black CM, du Bois RM, A multicenter, prospective, randomized, double-blind, placebo-controlled trial of corticosteroids and intravenous cyclophosphamide followed by oral azathioprine for the treatment of pulmonary fibrosis in scleroderma., Arthritis Rheum., 2006, 54, 12, 3962-3970, doi: 10.1002/art.22204.

Additional files

Editorial Notes