Description of the Functional Evolution of Diffuse Infiltrating Pneumonia Associated With Systemic Scleroderma.

Recruiting

• Conditions: Systemic Sclerosis
• Interventions: Other: lung function tests

• Registration Number: NCT03271333
• Lead Sponsor: University Hospital, Lille

Brief Summary

Diffuse infiltrating pneumonia (DIP) is a severe complication of systemic sclerosis and one of the leading cause of death in this condition. The main objective of this study is to prospectively describe the evolution of DIP overtime and to find prognosis factors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-31
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-05
• Study Start: 2018-04-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• systemic sclerosis
• Diffuse Infiltrating Pneumonia

Exclusion Criteria

• infection
• other lung diseases
• non French native

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with systemic sclerosis	lung function tests	-

Primary Outcome Measures

Name	Time	Method
composite criteria: forced vital capacity and CO diffusing capacity	At 24 months	Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 24 months.

Secondary Outcome Measures

Name	Time	Method
composite criteria: forced vital capacity and CO diffusing capacity	At 12 months	Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 12 months.

Trial Locations

Locations (2)

Hôpital Claude Huriez, CHU; 🇫🇷 Lille, France

AH-HP, Hôpital Saint Antoine; 🇫🇷 Paris 12, France