CALCification as an early marker of vasculopathy and organ involvement in Systemic Sclerosis CALC-SSc study - CALC-SSc study

niversity Medial Center Groningen0 sites120 target enrollmentJuly 9, 2018

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Systemic sclerosis (SSc) is a rare progressive autoimmune disease hallmarked by severe vasculopathy. Patients are prone to enhanced calcification of skin and the vasculature. Active calcifications may not only occur in the skin of patients with clinically overt calcinosis cutis, but also in SSc patients without. Since calcification is strongly associated with local inflammation, it may very well occur in internal organs and serve as an early proxy for long-term SSc-related complications.
Sponsor: niversity Medial Center Groningen
Enrollment: 120
Status: Active, not recruiting
Last Updated: 7 years ago

No summary available.

Registry

who.int

Start Date

July 9, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity Medial Center Groningen

•SSc patients:
•In order to be eligible to participate in this study as an SSc patient, a subject must meet all of the following criteria:
•18\-80 years
•Formal diagnosis of Systemic Sclerosis, as determined by a total of \=9 from adding the maximum weight (score) in each of the following categories (2013 ACR/EULAR criteria):
•oSkin thickening of the fingers of both hands extending proximal to the metacarpophalangeal joints (sufficient criterion) (9 points)
•oSkin thickening of the fingers (only count the higher score)
•?Puffy fingers (2 points)
•?Sclerodactyly of the fingers (distal to the metacarpophalangeal joints but proximal to the proximal interphalangeal joints) (4 points)
•oFingertip lesions (only count the higher score)
•?Digital tip ulcers (2 points)

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Women who are currently pregnant, planning to become pregnant, breastfeeding women, or women with child bearing potential not using appropriate contraceptive measures
•Patients who are mentally incompetent and cannot sign a Patient Informed Consent or are unwilling to sign a Patient Informed Consent
•Vascular event in the preceding 3 months (33\)
•Chemotherapy in the preceding 3 months (33\)
•Inflammation of unknown origin, sepsis, or vasculitis (34\)
•The next criteria will also be used for the substudy concerning 18F\-NaF PET/CT:
•Current active bone malignancy or in the previous 6 months (35\)
•Fractures or metastases within the evaluated bone regions, as well as metallic implants (33\)
•Disorders affecting bone metabolism, e.g. hyperparathyroidism, Paget’s disease (33\)