Systemic sclerosis associated interstitial lung disease: A longitudinal observational study assessing optimum treatment regimens. - Assessment of scleroderma lung disease

Phase 1

• Conditions: Systemic Sclerosis associated interstitial lung disease; MedDRA version: 9.1Level: LLTClassification code 10042953Term: Systemic sclerosis

• Registration Number: EUCTR2008-000224-27-GB
• Lead Sponsor: ewcastle upon Tyne NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-08-07
• Study Completion: 2011-07-31
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Fulfill 1980 ACR preliminary classification criteria for SSc
Age >18 yrs
Presence of HRCT evidence of any ground glass opacification as a marker of alveolitis or other changes consistent with ILD

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Persistent microscopic haematuria
Persistent leucopenia (neutrophil count <1.5 x 10 9 /l) or thrombocytopenia (<140 x 10 9/l)
Pregnant or breast feeding or absence of contraception
Active chronic infection in lung or elsewhere

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified