Digital Ulceration (CAP)

Actelion Pharmaceuticals

Status: Completed

Conditions: Systemic Sclerosis; Digital Ulcers

Study type: Observational

Funder types: Industry

Identifiers

NCT01377090

AC-052-521

Details and patient eligibility

About

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.

Enrollment: 630 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

630 participants in 2 patient groups

SSc DU-history subgroup

Description:

Systemic sclerosis patients with history of digital ulcers

SSc with No-DU-history subgroup

Description:

Systemic sclerosis patients with no history of digital ulcers