Digital Ulceration (CAP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01377090
First received: June 17, 2011
Last updated: July 11, 2013
Last verified: July 2013
  Purpose

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.


Condition
Systemic Sclerosis
Digital Ulcers

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Occurence of first new digital ulcer (DU) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Occurrence of the first new digital ulcer (DU) within 6 months


Enrollment: 630
Study Start Date: January 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with Systemic Sclerosis with or without a history of digital ulcers (DU)

Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377090

  Show 50 Study Locations
Sponsors and Collaborators
Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01377090     History of Changes
Other Study ID Numbers: AC-052-521
Study First Received: June 17, 2011
Last Updated: July 11, 2013
Health Authority: Austria: Ethikkommission
Belgium: Ethics Committee
Czech Republic: Ethics Committee
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: CNIL - Commission nationale de l'informatique et des libertés
Germany: Ethics Commission
Greece: Ethics Committee
Israel: Ethics Commission
Italy: Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Norway: Regional Ethics Commitee
Portugal: Ethics Committee for Clinical Research
Spain: Ethics Committee
Switzerland: Ethikkommission
Turkey: Ethics Committee
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Sclerosis
Ulcer
Connective Tissue Diseases
Skin Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014