A prospective randomised placebo controlled trial of treatment for fibrosing alveolitis in scleroderma

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN91217042

Enrollment

Registered

2002-07-15

Start date

1998-10-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibrosing alveolitis in scleroderma Musculoskeletal Diseases Systemic sclerosis

Interventions

Intravenous cyclophosphamide plus prednisolone for 6 months followed by azathioprine for 2.5 years or placebo for all drugs

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
1. Change in percent predicted Forced Vital Capacity (FVC) 2. Change in single-breath diffusing capacity for carbon monoxide (DLCO)	—

Secondary

Measure	Time frame
1. Changes in appearance on high-resolution computed tomography 2. Change in dyspnoea scores	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026