Efficacy and Safety of JAK Inhibitors in Systemic Sclerosis-associated Interstitial Lung Disease

NCT05177471 | Withdrawn

• 1 other identifier: 2021PI233
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. Janus kinases (JAK) inhibitors are recent therapies in the field of systemic autoimmune diseases, already approved in patients with rheumatoid arthritis. Use of JAK inhibitors in systemic sclerosis is based on their anti-inflammatory and anti-fibrotic properties. Several preclinical murine models of systemic sclerosis demonstrated the efficacy of ruxolitinib and tofacitinib on cutaneous and pulmonary fibrosis. Recently, tofacitinib was evaluated in SSc patients in two clinical studies and showed significant improvement on skin fibrosis. The objective of this study is to evaluate efficacy and safety of JAK inhibitors in SSc patients with ILD.

Conditions

Systemic Sclerosis; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• relative change in FVC after 12 months of JAK inhibitor

  relative change in %predicted FVC after 12 months of JAK inhibitor

  at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation

Secondary Outcomes (2)

• relative change in DLCO after 12 months of JAK inhibitor

  at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation

• relative change in skin fibrosis after 12 months of JAK inhibitor

  at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation

Study Arms (1)

SSc-ILD patients with JAK inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic sclerosis-interstitial lung disease

You may qualify if:

• Patients with systemic sclerosis according to 2013 ACR/EULAR criteria
• Patients with interstitial lung disease affecting at least 10 % of the lungs on HRCT chest, FVC of at least 40 % of the predicted value and DLCO between 30 % and 90 % of the predicted value
• Use of JAK inhibitors

You may not qualify if:

• Patients with an alternative diagnosis of SSc-associated ILD (silicosis, sarcoidosis, lung cancer or other significant lung abnormalities)
• Patients with pulmonary arterial hypertension defined on right heart catheterization

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHU Nancy

Vandœuvre-lès-Nancy, Grand Est, 54500, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: January 19, 2022
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: August 27, 2024

Record last verified: 2024-08

Locations

FR (1)