Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis

Systemic Sclerosis Clinical Trial

— SCLEROPIDEVOL  

Official title:

Evaluation of Interstitial Lung Disease Trajectories in Patients With Systemic Sclerosis (SCLEROPIDEVOL Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345795
• Other study ID #: 2022PI045
• Status: Recruiting
• Start date: May 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: August 2023
• Source: Central Hospital, Nancy, France
• Contact: Paul DECKER, MD
• Phone: +33383157240
• Email: p.decker[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Systemic sclerosis (SSc) is a heterogeneous systemic autoimmune disease with distinct prognosis according to patients. In patients with systemic sclerosis, interstitial lung disease (ILD) concerns almost 50 % of patients and represents the main cause of mortality. Disease course in SSc-ILD is highly variable: patients can experience stable disease, slow or fast progression. Prevention of ILD progression now represents a key objective of SSc-ILD management. The understanding of the course and patterns of SSc-ILD progression is necessary, as reliable prediction tools that allow the stratification of the risk of progression. We aimed to identify the longitudinal trajectories of ILD in SSc patients using latent class mixed models and to examine their associations with SSc characteristics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
• Patients with interstitial lung disease on HRCT chest
• Patients with PFT at ILD diagnosis and at least 1 PFT evaluation during follow-up

Exclusion Criteria:

• Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
France	CHU Nancy	Vandoeuvre-lès-nancy	Grand Est

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FVC change over time	evaluation of %predicted FVC values over time using latent class mixed models (LCMM)	at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis
Secondary	DLCO change over time	evaluation of %predicted DLCO values over time using latent class mixed models (LCMM)	at ILD diagnosis (Day 0) and within 5 years after ILD diagnosis