Systemic SclerosisNCT01834157
Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
An observational study of Systemic Sclerosis and Arthritis, run by Prof. Laszlo Czirjak at 33 sites in 14 countries.
Trial summary
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Sclerosis, Arthritis
- How many people
- 160 participants
- Where
- 33 sitesin 14 countries
- Study dates
- Apr 2013to Nov 2017
- 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 is adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort.
Who may be able to join
- Juvenile and adult Systemic sclerosis patients, with diagnosis according to the ACR/EULAR adult SSc criteria and PRES/ACR/EULAR juvenile SSc criteria respectively
- Clinical signs of arthritis (defined as ≥2 tender and swollen joints)
Who cannot join
- Presence of significant, long standing articular pain due to other cause than autoimmune disease
- Presence of hand disability caused by other, than autoimmune disease
Trial locations and contacts
33 sites in 14 countries.
Laszlo Czirjak, Prof. contact
33 sites in 14 countries
Germany8 sites, 8 recruiting
- Recruiting
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Bad Nauheim, 61231
Ulf Müller-Ladner, Prof.
- 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
Universitätshautklinik Köln
Cologne, 50397
Nicolas Hunzelmann, Prof.
- Recruiting
Universitätsklinikum Erlangen
Erlangen, 91054
Jörg Distler, Prof.
- Recruiting
Endokrinologikum Frankfurt
Frankfurt, 60596
Brigitte Krummel-Lorenz
- Recruiting
Centre for Pediatric Rheumatology, Klinikum Eilbek
Hamburg, 22081
Ivan Foeldvari, Dr.
- Recruiting
Medizinische Universitätsklinik Abt. II
Tübingen, 72076
Jörg Henes, Dr.
- Recruiting
Krankenhaus St. Josef
Wuppertal, 42105
Tim Schmeiser, Dr.
Italy6 sites, 6 recruiting
- Recruiting
Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona
Ancona, 60020
Armando Gabrielli, Prof.
- Recruiting
University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
Florence, 50139
Marco Matucci-Cerinic, Prof.
- Recruiting
Department of Rheumatology, University of Cagliari-Policlinico Universitario
Monserrato, 554
Alessandra Vacca
- Recruiting
Policlinico, Via Pansini
Napoli-Italia, 5-80131
Gabriele Valentini, Prof.
- Recruiting
University of Padova
Padova, 35128
Franco Cozzi, Prof.
- Recruiting
Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I
Roma, 00161
Guido Valesini, Prof.
Romania3 sites, 3 recruiting
- Recruiting
Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital
Bucharest, 020475
Carina Mihai
- Recruiting
Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj
Cluj-Napoca, 40 0006
Simona Rednic
- Recruiting
GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital
Iași, 700661
Cordina Ancuta
United Kingdom3 sites, 3 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.
- Recruiting
University of Manchester, Rheumatic Diseases Centre, Clinical Sciences
Manchester,Salford
Ariane Herrick
France2 sites, 2 recruiting
- Recruiting
Department of Internal Medicine Hôpital Claude Huriez
Lille, 59035
Eric Hachulla, Prof.
- Recruiting
Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
Paris, 75014
Yannick Allanore, Prof.
Russia2 sites, 2 recruiting
- Recruiting
Clinic of Nephrology, Internal and Occupational Diseases
Moscow, 119992
Sergey Moiseev, Prof.
Antonina Sosnovskaya
- Recruiting
Institute of Rheumatology, Russian Academy of Medical Science
Moscow, 119992
Lidia Ananieva, Prof.
Switzerland2 sites, 2 recruiting
- Recruiting
Felix-Platter Spital
Basel, CH 4012 Basel
Ulrich Walker, Prof.
- Recruiting
University of Zurich, Department of Rheumatology
Zurich, 8006
Oliver Distler, Prof.
Belgium1 site, 1 recruiting
- Recruiting
University of Ghent, Department of Rheumatology
Ghent, 9000
Vanessa Smith, Prof.
Croatia1 site, 1 recruiting
- Recruiting
Dubrava University Hospital
Zagreb
Jadranka Morovic-Vergles
Egypt1 site, 1 recruiting
- Recruiting
Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital
Asyut
Manal Hassanien
Hungary1 site, 1 recruiting
- Recruiting
Pecsi Tudomanyegyetem - University of Pecs
Pécs, H-7622
Laszlo Czirjak, Prof.
Serbia1 site, 1 recruiting
- Recruiting
Institute of Rheumatology Belgrade
Belgrade, 11000
Nemanja Damjanov, Prof.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario Madrid Norte Sanchinarro
Madrid
Paloma García de la Peña Lefebvre de la Peña Lefebvre, Prof.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
University of Marmara, Department of Rheumatology
Istanbul
Sule Kurhan Yavuz, Prof.
About this study
Official title: The "DeSScipher" Project - to Decipher the Best Treatment for Systemic Sclerosis - Observational Trial 2: Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related arthritis, too.
This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to:
- investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and
- to validate the CDAI for arthritis in systemic sclerosis.
- Conditions
- Systemic Sclerosis, Arthritis
- Medical subject headings
- Scleroderma, Systemic, Arthritis
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 |
|---|---|---|
| methotrexate | methotrexate with or without low-dose corticosteroids | |
| other DMARDs | other DMARDs (leflunomide, azathioprine, mycophenolate mofetil) with or without low-dose corticosteroids | |
| low-dose corticosteroids | low-dose corticosteroids without DMARDs | |
| No DMARD or corticosteroids | No DMARD or corticosteroid treatment | |
| CPH/CSA - Exploratory cohort | cyclophosphamide or cyclosporine-A with or without other DMARDs or low-dose corticosteroids | |
| Biologics - Exploratory cohort | Biologic therapy with or without other DMARDs or low-dose corticosteroids | |
| Combinations - Exploratory cohort | Combination of two or more DMARDs with or without low-dose corticosteroids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of HAQ-DI (CHAQ-DI in jSSc) by at least -0.21 in one year
Improvement from baseline in Health Assessment Questionnaire - Disability Index (Child Health Assessment Questionnaire - Disability Index in juvenile systemic sclerosis) by at least -0,21(moderate improvement) in one year
Measured: 12 months
Secondary outcomes (5)
Improvement of the CHFS in one year
Improvement of the Cochin Hand Function Scale in one year
Measured: 12 months
Improvement of the CDAI in one year
Improvement of the Clinical Disease Activity Index in one year
Measured: 12 months
Improvement of the SDAI in one year
Improvement of the Simplified Disease Activity Index in one year
Measured: 12 months
Improvement of the DAS28(We) in one year
Improvement of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in one year
Measured: 12 months
Improvement of the DAS28(CRP) in one year
Improvement of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in one year
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2017 (estimated)
- Study completionNov 2017 (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
- 160 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Prof. Laszlo Czirjak
- 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 Leeds, Schoen Klinik Hamburg Eilbek
- Responsible party
- Sponsor-investigator, Prof. Laszlo Czirjak, University of Pecs
- Investigators
- Ulf Müller-Ladner, Prof., Study chair, Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical ImmunologyLaszlo Czirjak, Prof, Principal investigator, PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834157
- Sponsor's protocol ID
- HEALTH-F5-2012-305495-OT2
- Status last verified
- Dec 2015
- First submitted
- 9 Apr 2013
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The "DeSScipher" Project - to Decipher the Best Treatment for Systemic Sclerosis - Observational Trial 2: Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT01834157
- Acronym / sponsor ID
- HEALTH-F5-2012-305495-OT2
- Conditions
- Systemic Sclerosis, Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Prof. Laszlo CzirjakUniversity, 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 Leeds, Schoen Klinik Hamburg Eilbek
- Study start
- Apr 2013
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Nov 2017 (estimated)
- First posted
- 17 Apr 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 several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related arthritis, too.
This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to:
- investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and
- to validate the CDAI for arthritis in systemic sclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| methotrexate | – | –methotrexate with or without low-dose corticosteroids |
| other DMARDs | – | –other DMARDs (leflunomide, azathioprine, mycophenolate mofetil) with or without low-dose corticosteroids |
| low-dose corticosteroids | – | –low-dose corticosteroids without DMARDs |
| No DMARD or corticosteroids | – | –No DMARD or corticosteroid treatment |
| CPH/CSA - Exploratory cohort | – | –cyclophosphamide or cyclosporine-A with or without other DMARDs or low-dose corticosteroids |
| Biologics - Exploratory cohort | – | –Biologic therapy with or without other DMARDs or low-dose corticosteroids |
| Combinations - Exploratory cohort | – | –Combination of two or more DMARDs with or without low-dose corticosteroids |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population is adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort.
Key inclusion criteria (2 listed)
- Juvenile and adult Systemic sclerosis patients, with diagnosis according to the ACR/EULAR adult SSc criteria and PRES/ACR/EULAR juvenile SSc criteria respectively
- Clinical signs of arthritis (defined as ≥2 tender and swollen joints)
Key exclusion criteria (2 listed)
- Presence of significant, long standing articular pain due to other cause than autoimmune disease
- Presence of hand disability caused by other, than autoimmune disease
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
Improvement of HAQ-DI (CHAQ-DI in jSSc) by at least -0.21 in one year
Time frame: 12 months
Improvement from baseline in Health Assessment Questionnaire - Disability Index (Child Health Assessment Questionnaire - Disability Index in juvenile systemic sclerosis) by at least -0,21(moderate improvement) in one year
5 secondary outcomes
Improvement of the CHFS in one year
Time frame: 12 months
Improvement of the CDAI in one year
Time frame: 12 months
Improvement of the SDAI in one year
Time frame: 12 months
Improvement of the DAS28(We) in one year
Time frame: 12 months
Improvement of the DAS28(CRP) in one year
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
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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.
Laszlo Czirjak, Prof. contact
Ulf Müller-Ladner, Prof. study chair
Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
Laszlo Czirjak, Prof principal investigator
PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS
33 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Arthritis, run by Prof. Laszlo Czirjak at 33 sites in 14 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 2 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: status not confirmed, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Germany, Italy, Romania, United Kingdom, France and 9 more countries. 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 Laszlo Czirjak, Prof. (laszlo.czirjak@aok.pte.hu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of HAQ-DI (CHAQ-DI in jSSc) by at least -0.21 in one year (time frame: 12 months). 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 22 Dec 2015.