Systemic SclerosisCAPNCT01377090
Digital Ulceration
An observational study of Systemic Sclerosis and Digital Ulcers, run by Actelion at 50 sites in 15 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis, Digital Ulcers
- How many people
- 630 participants
- Where
- 50 sitesin 15 countries
- Study dates
- Jan 2011to Aug 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Systemic Sclerosis with or without a history of digital ulcers (DU)
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
50 sites in 15 countries.
50 sites in 15 countries
Germany9 sites
Asklepios Klinikum Bad Abbach
Bad Abbach, 93077
Kerckhoff-Klinik GmbH
Bad Nauheim, 61321
Charité Universitätsmedizin Berlin
Berlin, 10117
Sankt Josef-Hospital, Klinikum der Ruhr-Universität Bochum
Bochum-Gerthe, 44805
Klinik und Poliklinik für Dermatologie und Venerologie der Universität zu Köln
Cologne, 50931
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Universitätsklinikum Halle (Saale)
Halle, 06112
Asklepios Klinik Altona
Hamburg, 22763
Universitätsklinikum Münster
Münster, 48149
France7 sites
Centre Hospitalier Universitaire Amiens
Amiens, 80054
Centre Hospitalier Universitaire de Grenoble
La Tronche, 38700
CHRU de Lille, hopital Claude Huriez, Service des maladies du sang
Lille, 59037
CHU Dupuytren
Limoges, 87042
Centre Hospitalier Universitaire de Nantes
Nantes, 44093
Groupe Hospitalier Cochin Saint Vincent de Paul
Paris, 75014
Hôpital Tenon
Paris, 75020
Italy6 sites
Universita degli Studi di Brescia
Brescia, 25123
Azienda Ospedaliera "Pugliese Ciaccio" di Catanzaro
Catanzaro, 88100
Azienda Ospedale San Martino
Genova, 16132
Ospedale Santa Ciara
Pisa, 56126
Policlinico Umberto I
Roma, 00161
Complesso Integrato Columbus
Roma, 00168
United Kingdom5 sites
Bath Institute for Rheumatic Diseases
Bath, BA1 1RL
Chapel Allerton Hospital
Leeds, LS7 4SA
Royal Free Hospital
London, NW3 2QG
Hope Hospital
Salford, M6 8HD
Wrightington Hospital
Wigan, WN6 9EP
Austria4 sites
Medizinische Universität Graz
Graz, 8036
Universitätsklinik für Innere Medizin Wien
Vienna, 1090
Sozialmedizinisches Zentrum Süd-Kaiser-Franz-Josef-Spital
Vienna, 1100
Hanusch Krankenhaus der Gebietskrankenkasse
Vienna, 1140
Spain4 sites
Hospital Sant Pau
Barcelona, 08025
Hospital Vall D'Hebron
Barcelona, 08035
Hospital de Mostoles
Madrid, 28935
Hospital Doctor Peset
Valencia, 46017
Belgium3 sites
Université Libre de Bruxelles Hopital Erasme
Brussels, 1070
Universitair Ziekenhuis Gent
Ghent, 9000
Universitair Ziekenhuis Leuven
Leuven, 3000
Israel3 sites
Rambam Medical Center
Haifa, 31096
Bnai Zion Medical Center
Haifa, 33394
Meir Medical Center
Kfar Saba, 49281
Switzerland3 sites
Centre Hospitalier Universitaire Vaudoise
Lausanne, 1011
Kantonspital Sankt Gallen
Sankt Gallen, 9007
UniversitätsSpital Zürich
Zurich, 8091
Turkey (Türkiye)1 site
Istanbul Universitesi Istanbul Tip Fakultesi
Istanbul, 34093
About this study
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)
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.
- Conditions
- Systemic Sclerosis, Digital Ulcers
- Medical subject headings
- Scleroderma, Systemic, digital ulcers
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 |
|---|---|---|
| SSc DU-history subgroup | Systemic sclerosis patients with history of digital ulcers | |
| SSc with No-DU-history subgroup | Systemic sclerosis patients with no history of digital ulcers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of first new digital ulcer (DU)
Occurrence of the first new digital ulcer (DU) within 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionAug 2012
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
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- Actelion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377090
- Sponsor's protocol ID
- AC-052-521
- Acronym
- CAP
- Status last verified
- Jul 2013
- First submitted
- 17 Jun 2011
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01377090
- Acronym / sponsor ID
- CAP / AC-052-521
- Conditions
- Systemic Sclerosis, Digital Ulcers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- ActelionIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 21 Jun 2011 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SSc DU-history subgroup | – | –Systemic sclerosis patients with history of digital ulcers |
| SSc with No-DU-history subgroup | – | –Systemic sclerosis patients with no history of digital ulcers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Systemic Sclerosis with or without a history of digital ulcers (DU)
Key inclusion criteria (6 listed)
- 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
- Enrollment must be within 2 years of the first physician-documented non-Raynaud clinical feature
Key exclusion criteria (4 listed)
- 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)
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
Occurence of first new digital ulcer (DU)
Time frame: 6 months
Occurrence of the first new digital ulcer (DU) within 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
50 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis and Digital Ulcers, run by Actelion at 50 sites in 15 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in Germany, France, Italy, United Kingdom, Austria and 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurence of first new digital ulcer (DU) (time frame: 6 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 15 Jul 2013.