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

Overview

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.

Full Title of Study: “Efficacy and Safety of JAK Inhibitors in Patients With Systemic Sclerosis and Interstitial Lung Disease”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: July 4, 2024

Arms, Groups and Cohorts

  • SSc-ILD patients with JAK inhibitors

Clinical Trial Outcome Measures

Primary Measures

  • relative change in FVC after 12 months of JAK inhibitor
    • Time Frame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
    • relative change in %predicted FVC after 12 months of JAK inhibitor

Secondary Measures

  • relative change in DLCO after 12 months of JAK inhibitor
    • Time Frame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
    • relative change in %predicted DLCO after 12 months of JAK inhibitor
  • relative change in skin fibrosis after 12 months of JAK inhibitor
    • Time Frame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
    • relative change in modified Rodnan skin score after 12 months of JAK inhibitor

Participating in This Clinical Trial

Inclusion Criteria

  • 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 Exclusion Criteria:

  • 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central Hospital, Nancy, France
  • Provider of Information About this Clinical Study
    • Principal Investigator: Paul DECKER, MD, Principal Investigator – Central Hospital, Nancy, France
  • Overall Contact(s)
    • Paul DECKER, MD, +33383157240, p.decker@chru-nancy.fr

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