Digital Ulceration

Systemic Sclerosis Clinical Trial

— CAP  

Official title:

A Multicenter, Prospective Cohort Study Using Nailfold VideoCAPillaroscopy(NVC) and Other Factors to Determine the Risk of Developing Digital Ulceration in Patients With Systemic Sclerosis (SSc)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377090
• Other study ID #: AC-052-521
• Status: Completed
• Phase: N/A
• First received: June 17, 2011
• Last updated: July 11, 2013
• Start date: January 2011
• Est. completion date: August 2012

Study information

• Verified date: July 2013
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: EthikkommissionBelgium: Ethics CommitteeCzech Republic: Ethics CommitteeFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéFrance: Conseil National de l'Ordre des MédecinsFrance: CNIL - Commission nationale de l'informatique et des libertésGermany: Ethics CommissionGreece: Ethics CommitteeIsrael: Ethics CommissionItaly: Ethics CommitteeNetherlands: Medical Ethics Review Committee (METC)Norway: Regional Ethics CommiteePortugal: Ethics Committee for Clinical ResearchSpain: Ethics CommitteeSwitzerland: EthikkommissionTurkey: Ethics CommitteeUnited Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial Summary

The CAP study is a multicenter, observational, clinical study in patients with systemic sclerosis. The study aims at determining the usefulness of nailfold videocapillaroscopy and patient-specific disease-related factors in predicting the occurrence of digital ulcers within a 6-month observation period. Patients with cutaneous forms of systemic sclerosis (limited or diffuse), with or without history of digital ulceration are eligible. The study will enroll 500 patients at 70 centers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

For all patients:

• Signed informed consent prior to enrollment

• Male or female, = 18 years of age

• Diagnosis of systemic sclerosis (SSc) according to the American College of Rheumatology and/or limited cutaneous SSc or diffuse cutaneous SSc according to LeRoy criteria

For patients with no history of digital ulcers (DU) and no DU at enrollment only:

• Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature

Exclusion Criteria:

• SSc sine scleroderma (without any skin involvement)

• Patients who underwent stem cell transplantation

• Participation in interventional clinical trials within 3 months prior to enrollment and/or during the study

• Inability to undergo Nailfold Videocapillaroscopy (NVC) assessment (e.g., inability to extend fingers sufficiently)

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Digital Ulcers
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Locations

Country	Name	City	State
Austria	Medizinische Universität Graz	Graz
Austria	Hanusch Krankenhaus der Gebietskrankenkasse	Vienna
Austria	Sozialmedizinisches Zentrum Süd-Kaiser-Franz-Josef-Spital	Vienna
Austria	Universitätsklinik für Innere Medizin Wien	Vienna
Belgium	Université Libre de Bruxelles Hopital Erasme	Brussels
Belgium	Universitair Ziekenhuis Gent	Gent
Belgium	Universitair Ziekenhuis Leuven	Leuven
Czech Republic	Revmatologický ústav	Prague
France	Centre Hospitalier Universitaire Amiens	Amiens Cedex 1
France	Centre Hospitalier Universitaire de Grenoble	La Tronche
France	CHRU de Lille, hopital Claude Huriez, Service des maladies du sang	Lille
France	CHU Dupuytren	Limoges cedex
France	Centre Hospitalier Universitaire de Nantes	Nantes cedex 1
France	Groupe Hospitalier Cochin Saint Vincent de Paul	Paris
France	Hôpital Tenon	Paris
Germany	Asklepios Klinikum Bad Abbach	Bad Abbach
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Charité Universitätsmedizin Berlin	Berlin
Germany	Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum	Bochum-Gerthe
Germany	Universitätsklinikum Düsseldorf	Düsseldorf
Germany	Universitätsklinikum Halle (Saale)	Halle
Germany	Asklepios Klinik Altona	Hamburg
Germany	Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln	Köln
Germany	Universitätsklinikum Münster	Münster
Greece	Laiko Hospital	Athens
Israel	Bnai Zion Medical Center	Haifa
Israel	Rambam Medical Center	Haifa
Israel	Meir Medical Center	Kfar Saba
Italy	Universita degli Studi di Brescia	Brescia
Italy	Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro	Catanzaro
Italy	Azienda Ospedale San Martino	Genova
Italy	Ospedale Santa Ciara	Pisa
Italy	Complesso Integrato Columbus	Roma
Italy	Policlinico Umberto I	Roma
Netherlands	Vrije Universiteit Medisch Centrum	Amsterdam
Norway	Revmatismesykehuset	Lillehammer
Portugal	Hospital Geral de Santo Antonio	Porto
Spain	Hospital Sant Pau	Barcelona
Spain	Hospital Vall D'Hebron	Barcelona
Spain	Hospital de Mostoles	Madrid
Spain	Hospital Doctor Peset	Valencia
Switzerland	Centre Hospitalier Universitaire Vaudoise	Lausanne
Switzerland	Kantonspital Sankt Gallen	Sankt Gallen
Switzerland	UniversitätsSpital Zürich	Zurich
Turkey	Istanbul Universitesi Istanbul Tip Fakultesi	Istanbul
United Kingdom	Bath Institute for Rheumatic Diseases	Bath
United Kingdom	Chapel Allerton Hospital	Leeds
United Kingdom	Royal Free Hospital	London
United Kingdom	Hope Hospital	Salford
United Kingdom	Wrightington Hospital	Wigan

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  France,  Germany,  Greece,  Israel,  Italy,  Netherlands,  Norway,  Portugal,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurence of first new digital ulcer (DU)	Occurrence of the first new digital ulcer (DU) within 6 months	6 months	No