NCT03271333

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 5, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

April 10, 2018

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 11, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

6.7 years

First QC Date

August 31, 2017

Last Update Submit

December 16, 2025

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

  • composite criteria: forced vital capacity and CO diffusing capacity

    Degradation of forced vital capacity (FVC) ≥10% and / or DLCO ≥15% of initial values at prospective follow-up at 24 months.

    At 24 months

Secondary Outcomes (1)

  • composite criteria: forced vital capacity and CO diffusing capacity

    At 12 months

Study Arms (1)

patients with systemic sclerosis

Other: lung function tests

Interventions

lung function testsOTHER

Patients hospitalized realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes)

patients with systemic sclerosis

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with systemic sclerosis and Diffuse Infiltrating Pneumonia

You may qualify if:

  • systemic sclerosis
  • Diffuse Infiltrating Pneumonia

You may not qualify if:

  • infection
  • other lung diseases
  • non French native

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Claude Huriez, CHU

Lille, France

Location

AH-HP, Hôpital Saint Antoine

Paris, 75571, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

  • David Launay, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2017

First Posted

September 5, 2017

Study Start

April 10, 2018

Primary Completion

December 31, 2024

Study Completion

December 11, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)