An observational study in Systemic Sclerosis and Interstitial Lung Disease, sponsored by Central Hospital, Nancy, France. Withdrawn at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-27.
Sponsored by Central Hospital, Nancy, France · Observational
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
Browse Lung Diseases studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with systemic sclerosis-interstitial lung disease
Exclusion Criteria:
relative change in FVC after 12 months of JAK inhibitor
relative change in %predicted FVC after 12 months of JAK inhibitor
Time frame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
relative change in DLCO after 12 months of JAK inhibitor
relative change in %predicted DLCO after 12 months of JAK inhibitor
Time frame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
relative change in skin fibrosis after 12 months of JAK inhibitor
relative change in modified Rodnan skin score after 12 months of JAK inhibitor
Time frame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
This study is withdrawn, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Central Hospital, Nancy, France