Double Immunosuppression With or Without Anti-fibrotic in Scleroderma ILD
ConditionSSc-Systemic Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Patras
About this trial
Patients with ssc-ild receiving double immunosuppression with or without anti fibrotic tratment
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
ssc without ild
Trial population
Patients with ssc-ild
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Antifibrotic drugs (nidanib or pirfenidone)
DrugSsc - ild
MMF Immunosuppression
Drugwe will compare patients with SSc-ILD taking RTX and mmf and patients that are taking RTX,mmf and nintedanib
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Patient with ssc-ild with a double immunosuppression treatment and with anti fibrotic2 interventions
Group B: Patient with ssc-ild with a double immunosuppression treatment only1 intervention
Trial outcomes
Primary outcomes
1
pulmonary function test
For outcome number 1: FVC as a percentage compared to normal values (for age, sex, weight) at: Baseline and at 3, 6 and 12 months of treatment. Comparisons will be performed between baseline and each subsequent value at each prespecified time point. For outcome number 2: FEV1 as a percentage compared to normal values (for age, sex, weight) at: Baseline and at 3, 6 and 12 months of treatment. Comparisons will be performed between baseline and each subsequent value obtained at each prespecified time point. For outcome number 3: FEV1/FVC (ratio) compared to normal values (for age, sex, weight) at: Baseline and at 3, 6 and 12 months of treatment. Comparisons will be performed between baseline and each subsequent value obtained at each prespecified time point. For outcome number 4: TLCO (corrected for Ht) as a percentage compared to normal values (for age, sex, weight) at: Baseline and at 3, 6 and 12 months of treatment. Comparisons will be performed as described above.
Time frame
From enrollment till the end of study -1 years laterSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov