Systemic SclerosisNCT01858259
Treatment and Prevention of Progression of Interstitial Lung Disease in Systemic Sclerosis
An observational study of Systemic Sclerosis and Interstitial Lung Diseases, run by Gabriela Riemekasten at 11 sites in 6 countries.
Trial summary
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Sclerosis, Interstitial Lung Diseases
- How many people
- 1,372 participants
- Where
- 11 sitesin 6 countries
- Study dates
- May 2013to Jun 2016
- How long will I take part?
- 12 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort
Who may be able to join
- 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
Who cannot join
- Patients with previous exposure to silica or asbestos
Trial locations and contacts
11 sites in 6 countries.
Gabriela Riemekasten, Prof. contact
Christopher Denton, Prof. contact
11 sites in 6 countries
Germany3 sites, 3 recruiting
- Recruiting
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, 61231
Ulf Müller-Ladner, Prof.
Ingo H. Tarner, Dr.
- Recruiting
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Berlin, 10117
Gabriela Riemekasten, Prof.
- Recruiting
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, 22081
Ivan Foeldvari, Dr.
Italy2 sites, 2 recruiting
- Recruiting
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, 50139
Marco Matucci-Cerinic, Prof.
- Recruiting
Policlinico, Via Pansini
Napoli-Italia, 5-80131
Gabriele Valentini, Prof
Switzerland2 sites, 2 recruiting
- Recruiting
Felix-Platter Spital, University of Basel
Basel, CH 4012 Basel
Ulrich Walker, Prof.
- Recruiting
University of Zurich, Department of Rheumatology
Zurich, 8006
Oliver Distler, Prof.
United Kingdom2 sites, 2 recruiting
- Recruiting
The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
Leeds, LS9 7TF
Francesco Del Galdo, Dr.
- Recruiting
Royal Free Hospital, University College London
London, NW3 2QG
Christopher Denton, Prof.
France1 site, 1 recruiting
- Recruiting
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, 75014
Yannick Allanore, Prof.
Hungary1 site, 1 recruiting
- Recruiting
Pecsi Tudomanyegyetem - University of Pecs
Pécs, H-7622
Laszlo Czirjak, Prof.
About this study
Official title: Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis.
This observational trial (OT) is part of the collaborative project "DeSScipher", one out of five OTs to decipher the optimal management of systemic sclerosis. 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
Read the detailed description
Patients are routinely evaluated every 3 months over a 12-months period by medical history, physical examination, pulmonary function tests, VAS lung score and SF-36, SHAQ. Also, their medication and possible medication changes will be recorded.
- Conditions
- Systemic Sclerosis, Interstitial Lung Diseases
- 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 |
|---|---|---|
| cyclophosphamide | Patients receiving cyclophosphamide | |
| azathioprine | Patients receiving azathioprine | |
| mycophenolate mofetil | Patients receiving mycophenolate mofetil | |
| methotrexate | Patients receiving methotrexate | |
| no therapy | Patients receiving no immunosuppressive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with 10% decline in FVC
The proportion of patients with ILD progression as defined by a 10% decline in FVC within 1 year of therapy
Measured: 1 year
Secondary outcomes (3)
The time to a 15% decline in DLCO or a drop <55% of predicted lung function
Measured: 1 year
The mortality due to lung fibrosis
Measured: 1 year
The need for oxygen support
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
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.
- 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
- Prospective
- Enrolment
- 1,372 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Gabriela Riemekasten
- Sponsor type
- University, hospital or other
- Collaborators
- European Union, University of Giessen, University of Zurich, University of Paris 5 - Rene Descartes, University of Florence, University of Campania Luigi Vanvitelli, University of Basel, University College, London, Charite University, Berlin, Germany, University of Pecs, University of Leeds, Schoen Klinik Hamburg Eilbek
- Responsible party
- Sponsor-investigator, Gabriela Riemekasten, Charite University, Berlin, Germany
- Investigators
- Gabriela Riemekasten, Prof., Principal investigator, Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische ImmunologieChristopher Denton, Prof., Principal investigator, Royal Free Hospital, University College London LondonUlf Müller-Ladner, Prof., Study chair, Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858259
- Sponsor's protocol ID
- HEALTH-F5-2012-305495-OT3
- Status last verified
- Aug 2014
- First submitted
- 14 May 2013
- Last updated
- 13 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention and Treatment of Interstitial Lung Disease in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01858259
- Acronym / sponsor ID
- HEALTH-F5-2012-305495-OT3
- Conditions
- Systemic Sclerosis, Interstitial Lung Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,372 participants (estimated)
- Lead sponsor
- Gabriela RiemekastenUniversity, hospital or other
- Collaborators
- European Union, University of Giessen, University of Zurich, University of Paris 5 - Rene Descartes, University of Florence, University of Campania Luigi Vanvitelli, University of Basel, University College, London, Charite University, Berlin, Germany, University of Pecs, University of Leeds, Schoen Klinik Hamburg Eilbek
- Study start
- May 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 21 May 2013 (estimated)
- 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 an orphan, multiorgan disease affecting the connective tissue of the skin and all internal organs. Interstitial lung disease is a frequent morbidity and mortality-driving manifestation in systemic sclerosis.
This observational trial (OT) is part of the collaborative project "DeSScipher", one out of five OTs to decipher the optimal management of systemic sclerosis. 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
Detailed description
Patients are routinely evaluated every 3 months over a 12-months period by medical history, physical examination, pulmonary function tests, VAS lung score and SF-36, SHAQ. Also, their medication and possible medication changes will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| cyclophosphamide | – | –Patients receiving cyclophosphamide |
| azathioprine | – | –Patients receiving azathioprine |
| mycophenolate mofetil | – | –Patients receiving mycophenolate mofetil |
| methotrexate | – | –Patients receiving methotrexate |
| no therapy | – | –Patients receiving no immunosuppressive therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population are adult and juvenile SSc patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with previous exposure to silica or asbestos
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
Proportion of patients with 10% decline in FVC
Time frame: 1 year
The proportion of patients with ILD progression as defined by a 10% decline in FVC within 1 year of therapy
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2014.
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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.
Gabriela Riemekasten, Prof. contact
Christopher Denton, Prof. contact
Gabriela Riemekasten, Prof. principal investigator
Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
Christopher Denton, Prof. principal investigator
Royal Free Hospital, University College London London
Ulf Müller-Ladner, Prof. study chair
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
11 sites in 6 countries: 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 Diseases, run by Gabriela Riemekasten at 11 sites in 6 countries.
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 1 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: status not confirmed, as of the sponsor's last update on 13 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, Italy, Switzerland, United Kingdom, France and 1 more country. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Riemekasten, Prof. (Gabriela.Riemekasten@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with 10% decline in FVC (time frame: 1 year). 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 13 Aug 2014.