Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

NCT01834157 | Unknown

• 1 other identifier: HEALTH-F5-2012-305495-OT2
• Study Type: observational
• Target: 160
• Locations: 14 countries
• Sites: 33

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (5)

• Improvement of the CHFS in one year

  12 months

• Improvement of the CDAI in one year

  12 months

• Improvement of the SDAI in one year

  12 months

• Improvement of the DAS28(We) in one year

  12 months

• Improvement of the DAS28(CRP) in one year

  12 months

Other Outcomes (7)

• Validation of the CDAI in systemic sclerosis

  12 months

• Validation of the SDAI in systemic sclerosis

  12 months

• Validation of the DAS28(ESR) in systemic sclerosis

  12 months

Study Arms (7)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Prof. Laszlo Czirjak: lead
• European Union: collaborator
• University of Giessen: collaborator
• University of Zurich: collaborator
• University of Paris 5 - Rene Descartes: collaborator
• University of Florence: collaborator
• University of Campania Luigi Vanvitelli: collaborator
• University of Basel: collaborator
• University College, London: collaborator
• Charite University, Berlin, Germany: collaborator
• University of Leeds: collaborator
• Schoen Klinik Hamburg Eilbek: collaborator

Study Sites (33)

University of Ghent, Department of Rheumatology

Ghent, 9000, Belgium

RECRUITING

Dubrava University Hospital

Zagreb, Croatia

RECRUITING

Assiut and Sohage University Hospital Rheumatology Department Assiut University Hospital

Asyut, Egypt

RECRUITING

Department of Internal Medicine Hôpital Claude Huriez

Lille, 59035, France

RECRUITING

Université Paris Descartes, Hôpital Cochin, Service de Rhumatologie A & INSERM 1016

Paris, 75014, France

RECRUITING

Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

Bad Nauheim, 61231, Germany

RECRUITING

Charité Universitätsmedizin Berlin, Charité Centrum 12 für Innere Medizin und Dermatologie, Medizinische Klinik mit Schwerpunkt Rheumatologie und Klinische Immunologie

Berlin, 10117, Germany

RECRUITING

Universitätshautklinik Köln

Cologne, 50397, Germany

RECRUITING

Universitätsklinikum Erlangen

Erlangen, 91054, Germany

RECRUITING

Endokrinologikum Frankfurt

Frankfurt, 60596, Germany

RECRUITING

Centre for Pediatric Rheumatology, Klinikum Eilbek

Hamburg, 22081, Germany

RECRUITING

Medizinische Universitätsklinik Abt. II

Tübingen, 72076, Germany

RECRUITING

Krankenhaus St. Josef

Wuppertal, 42105, Germany

RECRUITING

Pecsi Tudomanyegyetem - University of Pecs

Pécs, H-7622, Hungary

RECRUITING

Istituto di Clinica Medica Generale, Ematologia ed Immunologia Clinica, Università Politecnica delle Marche, Polo Didattico, University of Ancona

Ancona, 60020, Italy

RECRUITING

University of Florence, Denothe Centre, Division of Rheumatology AOUC, Department of Biomedicine

Florence, 50139, Italy

RECRUITING

Department of Rheumatology, University of Cagliari-Policlinico Universitario

Monserrato, 554, Italy

RECRUITING

Policlinico, Via Pansini

Napoli-Italia, 5-80131, Italy

RECRUITING

University of Padova

Padua, 35128, Italy

RECRUITING

Divisione di Reumatologia, Università di Roma La Sapienza, Dipartimento di Clinica e Terapia medica applicata, Policlinico Umberto I

Roma, 00161, Italy

RECRUITING

Department of Internal Medicine and Rheumatology Clinic, Ion Cantacuzino Clinical Hospital

Bucharest, 020475, Romania

RECRUITING

Reumatologie, University of Medicine & Pharmacy,"Iuliu Hatieganu" Cluj

Cluj-Napoca, 40 0006, Romania

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, Romania

RECRUITING

Clinic of Nephrology, Internal and Occupational Diseases

Moscow, 119992, Russia

RECRUITING

Institute of Rheumatology, Russian Academy of Medical Science

Moscow, 119992, Russia

RECRUITING

Institute of Rheumatology Belgrade

Belgrade, 11000, Serbia

RECRUITING

Hospital Universitario Madrid Norte Sanchinarro

Madrid, Spain

RECRUITING

Felix-Platter Spital

Basel, CH 4012 Basel, Switzerland

RECRUITING

University of Zurich, Department of Rheumatology

Zurich, 8006, Switzerland

RECRUITING

University of Marmara, Department of Rheumatology

Istanbul, Turkey (Türkiye)

RECRUITING

The Universitiy of Leeds, Division of Rheumatic and Musculoskeletal Disease, St James's University Hospital

Leeds, LS9 7TF, United Kingdom

RECRUITING

Royal Free Hospital, University College London

London, NW3 2QG, United Kingdom

RECRUITING

University of Manchester, Rheumatic Diseases Centre, Clinical Sciences

Manchester,Salford, United Kingdom

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic; Arthritis

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Joint Diseases; Musculoskeletal Diseases

Study Officials

• Ulf Müller-Ladner, Prof.

  Justus-Liebig-University Gießen, Kerckhoff Clinic, Departement of Rheumatology and Clinical Immunology

  STUDY CHAIR

• Laszlo Czirjak, Prof

  PECSI TUDOMANYEGYETEM - UNIVERSITY OF PECS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laszlo Czirjak, Prof.

CONTACT

laszlo.czirjak@aok.pte.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Laszlo Czirjak

Study Record Dates

• First Submitted: April 9, 2013
• First Posted: April 17, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: December 22, 2015

Record last verified: 2015-12

Locations

RO (3); ES (1); SE (1); CH (2); BE (1); HU (1); GB (3); TU (1); CR (1); DE (8); EG (1); IT (6); RU (2); FR (2)