Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

December 21, 2015 updated by: Prof. Laszlo Czirjak

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Gent, Belgium, 9000
        • Recruiting
        • University of Ghent, Department of Rheumatology
        • Principal Investigator:
          • Vanessa Smith, Prof.
  • Croatia
      • Zagreb, Croatia
        • Recruiting
        • Dubrava University Hospital
        • Principal Investigator:
          • Jadranka Morovic-Vergles
  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital
        • Principal Investigator:
          • Manal Hassanien
  • France
      • Lille cedex, France, 59035
        • Recruiting
        • Department of Internal Medicine Hôpital Claude Huriez
        • Principal Investigator:
          • Eric Hachulla, Prof.
      • Paris, France, 75014
        • Recruiting
        • Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016
        • Principal Investigator:
          • Yannick Allanore, Prof.
  • Germany
      • Bad Nauheim, Germany, 61231
        • Recruiting
        • Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
        • Principal Investigator:
          • Ulf Müller-Ladner, Prof.
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie
        • Principal Investigator:
          • Gabriela Riemekasten, Prof.
      • Cologne, Germany, 50397
        • Recruiting
        • Universitätshautklinik Köln
        • Principal Investigator:
          • Nicolas Hunzelmann, Prof.
      • Erlangen, Germany, 91054
        • Recruiting
        • Universitätsklinikum Erlangen
        • Principal Investigator:
          • Jörg Distler, Prof.
      • Frankfurt, Germany, 60596
        • Recruiting
        • Endokrinologikum Frankfurt
        • Principal Investigator:
          • Brigitte Krummel-Lorenz
      • Hamburg, Germany, 22081
        • Recruiting
        • Centre for Pediatric Rheumatology, Klinikum Eilbek
        • Principal Investigator:
          • Ivan Foeldvari, Dr.
      • Tübingen, Germany, 72076
        • Recruiting
        • Medizinische Universitätsklinik Abt. II
        • Principal Investigator:
          • Jörg Henes, Dr.
      • Wuppertal, Germany, 42105
        • Recruiting
        • Krankenhaus St. Josef
        • Principal Investigator:
          • Tim Schmeiser, Dr.
  • Hungary
      • Pecs, Hungary, H-7622
        • Recruiting
        • Pecsi Tudomanyegyetem - University of Pecs
        • Principal Investigator:
          • Laszlo Czirjak, Prof.
  • Italy
      • Ancona, Italy, 60020
        • Recruiting
        • Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona
        • Principal Investigator:
          • Armando Gabrielli, Prof.
      • Firenze, Italy, 50139
        • Recruiting
        • University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine
        • Principal Investigator:
          • Marco Matucci-Cerinic, Prof.
      • Monserrato, Italy, 554
        • Recruiting
        • Department of Rheumatology, University of Cagliari-Policlinico Universitario
        • Principal Investigator:
          • Alessandra Vacca
      • Napoli-Italia, Italy, 5-80131
        • Recruiting
        • Policlinico, Via Pansini
        • Principal Investigator:
          • Gabriele Valentini, Prof.
      • Padova, Italy, 35128
        • Recruiting
        • University of Padova
        • Principal Investigator:
          • Franco Cozzi, Prof.
      • Roma, Italy, 00161
        • Recruiting
        • Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I
        • Principal Investigator:
          • Guido Valesini, Prof.
  • Romania
      • Bucharest, Romania, 020475
        • Recruiting
        • Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital
        • Principal Investigator:
          • Carina Mihai
      • Cluj-Napoca, Romania, 40 0006
        • Recruiting
        • Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj
        • Principal Investigator:
          • Simona Rednic
      • Iasi, Romania, 700661
        • Recruiting
        • GR.T.Popa Center for Biomedical Research, European Center for Translational Research, "GR.T.Popa" University of Medicine and Pharmacy, Rehabilitation Hospital
        • Principal Investigator:
          • Cordina Ancuta
  • Russian Federation
      • Moscow, Russian Federation, 119992
        • Recruiting
        • Clinic of Nephrology, Internal and Occupational Diseases
        • Principal Investigator:
          • Sergey Moiseev, Prof.
        • Sub-Investigator:
          • Antonina Sosnovskaya
      • Moscow, Russian Federation, 119992
        • Recruiting
        • Institute of Rheumatology, Russian Academy of Medical Science
        • Principal Investigator:
          • Lidia Ananieva, Prof.
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Institute of Rheumatology Belgrade
        • Principal Investigator:
          • Nemanja Damjanov, Prof.
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Universitario Madrid Norte Sanchinarro
        • Principal Investigator:
          • Paloma García de la Peña Lefebvre de la Peña Lefebvre, Prof.
  • Switzerland
      • Basel, Switzerland, CH 4012 Basel
        • Recruiting
        • Felix-Platter Spital
        • Principal Investigator:
          • Ulrich Walker, Prof.
      • Zurich, Switzerland, 8006
        • Recruiting
        • University of Zurich, Department of Rheumatology
        • Principal Investigator:
          • Oliver Distler, Prof.
  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • University of Marmara, Department of Rheumatology
        • Principal Investigator:
          • Sule Kurhan Yavuz, Prof.
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital
        • Principal Investigator:
          • Francesco Del Galdo, Dr.
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital, University College London
        • Principal Investigator:
          • Christopher Denton, Prof.
      • Manchester,Salford, United Kingdom
        • Recruiting
        • University of Manchester, Rheumatic Diseases Centre, Clinical Sciences
        • Principal Investigator:
          • Ariane Herrick

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population is adult and juvenile systemic sclerosis patients from the EUSTAR cohort (MEDSonline database) and the jSScWG cohort.

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • Presence of significant, long standing articular pain due to other cause than autoimmune disease
  • Presence of hand disability caused by other, than autoimmune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of the CHFS in one year
Time Frame: 12 months
Improvement of the Cochin Hand Function Scale in one year
12 months
Improvement of the CDAI in one year
Time Frame: 12 months
Improvement of the Clinical Disease Activity Index in one year
12 months
Improvement of the SDAI in one year
Time Frame: 12 months
Improvement of the Simplified Disease Activity Index in one year
12 months
Improvement of the DAS28(We) in one year
Time Frame: 12 months
Improvement of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in one year
12 months
Improvement of the DAS28(CRP) in one year
Time Frame: 12 months
Improvement of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in one year
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the CDAI in systemic sclerosis
Time Frame: 12 months
Exploratory endpoint: Validation of the Clinical Disease Activity Index in systemic sclerosis
12 months
Validation of the SDAI in systemic sclerosis
Time Frame: 12 months
Exploratory endpoint: Validation of the Simplified Disease Activity Index in systemic sclerosis
12 months
Validation of the DAS28(ESR) in systemic sclerosis
Time Frame: 12 months
Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including erythrocyte sedimentation rate) in systemic sclerosis
12 months
Validation of the DAS28(CRP) in systemic sclerosis
Time Frame: 12 months
Exploratory endpoint: Validation of the Disease Activity Score 28 (using 4 variables, including C-reactive protein) in systemic sclerosis
12 months
Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis
Time Frame: 24 months
Evaluation of the incidence and potential predictors of deterioration of hand dysfunction and progression of arthritis in systemic sclerosis
24 months
Incidence of drug-related adverse events
Time Frame: 24 months
Evaluation of the incidence of drug-related adverse events
24 months
Incidence of withdrawal from treatment due to drug-related adverse events
Time Frame: 24 months
Evaluation of the incidence of withdrawal from treatment due to drug-related adverse events
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Laszlo Czirjak

Collaborators

Charite University, Berlin, Germany
University of Zurich
University College, London
University of Leeds
University of Campania "Luigi Vanvitelli"
University of Basel
University of Giessen
University of Florence
European Union
University of Paris 5 - Rene Descartes
Schoen Klinik Hamburg Eilbek

Investigators

  • Study Chair: Ulf Müller-Ladner, Prof., Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology
  • Principal Investigator: Laszlo Czirjak, Prof, Pecsi Tudomanyegyetem - University of Pecs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Anticipated)

November 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

April 9, 2013

First Submitted That Met QC Criteria

April 13, 2013

First Posted (Estimate)

April 17, 2013

Study Record Updates

Last Update Posted (Estimate)

December 22, 2015

Last Update Submitted That Met QC Criteria

December 21, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEALTH-F5-2012-305495-OT2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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