Systemic SclerosisSCLEROJAKINCT05177471
Efficacy and Safety of JAK Inhibitors in Systemic Sclerosis-associated Interstitial Lung Disease
An observational study of Systemic Sclerosis and Interstitial Lung Disease, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Interstitial Lung Disease
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2022to 26 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic sclerosis-interstitial lung disease
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of JAK Inhibitors in Patients With Systemic Sclerosis and Interstitial Lung Disease
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.
Read more
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
- Medical subject headings
- Scleroderma, Systemic, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SSc-ILD patients with JAK inhibitors | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
relative change in FVC after 12 months of JAK inhibitor
relative change in %predicted FVC after 12 months of JAK inhibitor
Measured: 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
relative change in %predicted DLCO after 12 months of JAK inhibitor
Measured: 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
Measured: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start19 Jan 2022
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Why it stopped: no eligible patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul DECKER, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177471
- Sponsor's protocol ID
- 2021PI233
- Acronym
- SCLEROJAKI
- Status last verified
- Aug 2024
- First submitted
- 15 Dec 2021
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of JAK Inhibitors in Patients With Systemic Sclerosis and Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT05177471
- Acronym / sponsor ID
- SCLEROJAKI / 2021PI233
- Conditions
- Systemic Sclerosis, Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: no eligible patients
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SSc-ILD patients with JAK inhibitors | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic sclerosis-interstitial lung disease
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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 skin fibrosis after 12 months of JAK inhibitor
Time frame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Interstitial Lung Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relative change in FVC after 12 months of JAK inhibitor (time frame: at JAK inhibitor initiation (J0) and 12 months after JAK inhibitor initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2024.