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OT 3 - Prevention and treatment of interstitial lung disease

Lung fibrosis and resulting shortness of breath is one of the most important organ involvements of Systemic Sclerosis that reduces quality of life and limits daily activities. This observational trial aims to identify the current state of clinical practice for theprevention and treatment of lung fibrosis, its effect on lung function and disease progression and potential predictors for the response to therapy of the individual patient.

The following protocol gives you a brief summary of observational trial 3:

 

 PI: Gabriela RIEMEKASTEN (CHARITÉ ), Christopher DENTON (UCL)

 Investigative objective

 Aim of this observational try is to identify:

  • The state of clinical practice in Europe for prevention and treatment of interstitial lung disease and its impact on lung function and disease progression
  • The potential predictors and confounders for response to therapy

 Primary endpoint(s)

Proportion of patients with 10% decline in FVC (Time Frame: 1 year)

 Secondary endpoint(s)
  •  The time to a 15% decline in DLCO or a drop <55% of predicted lung function (Time Frame: 1 year)
  • The mortality due to lung fibrosis (Time Frame: 1 year)
  • The need for oxygen support (Time Frame: 1 year)

 Exploratory endpoints

 Identification of parameters with impact on ILD progression independent of therapies, such as SSc subgroups, presence of antibodies, presence of vasculopathy, time to therapy initiation, degree of lung fibrosis defined by FVC values, age at disease onset and at treatment initiation, gender, co-morbidities and other confounders

Safety endpoints

 Incidence of drug-related adverse events, incidence of withdrawal from treatment due to drug-related adverse events

 Participants

 Study population justification

The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort

 Inclusion criteria
  • Diagnosis fo SSc according to the ACR/EULAR criteria for adult or the PRES/ACR/EULAR criteria for juvenile SSc patients
  • SSc patients with proven ILD (by X-ray or CT scan)
  • Treatment with standard dosages according to current practice with (i) Cyclophosphamide, (ii) Azathioprine, (iii) Mycophenolate Mofetil, (iv) Methotrexate, or (v) no therapy
Exclusion criteria  Patients with previous exposure to silica or asbestos

Treatment arms

Four different groups will be observed for analysis:

  • Patients receiving Cyclophosphamide
  • Patients receiving Azathioprine
  • Patients receiving Mycophenolate Mofetil
  • Patients receiving Methotrexate
  • Patients receiving no therapy 
ClinicalTrials.gov Identifier: NCT01858259

For further Information:
http://clinicaltrials.gov/ct2/show/NCT01858259?term=desscipher&rank=1