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

Phase 1

• 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.; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2018-001719-65-NL
• Lead Sponsor: niversity Medial Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-09
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

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)
?Fingertip pitting scars (3 points)
oTelangiectasia (2 points)
oAbnormal nailfold capillaries (2 points)
oPulmonary involvement (maximum score is 2)
?Pulmonary arterial hypertension (2 points)
?Interstitial lung disease (2 points)
oRaynaud’s phenomenon (3 points)
oSSc-related autoantibodies (maximum score is 3)
?Anticentromere (3 points)
?anti–topoisomerase I [anti–Scl-70] (3 points)
?anti–RNA polymerase III (3 points)
•Written informed consent

Controls:
In order to be eligible to participate in this study as a patient with primary Raynaud’s phenomenon, a subject must meet all of the following criteria:
•18-80 years
•Negatieve antinuclear antibodies (ANA)
•Normal nailfold capillairies
•No underlying disease
•Written informed consent

Healthy controls:
In order to be eligible to participate in this study as a healthy control, a subject must meet all of the following criteria:
•18-80 years
•No apparent underlying chronic disease
•No signs and symptoms suggesting Raynaud phenomenon or other vascular disease
•Written informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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)
•Patients who have claustrophobia (16)
•Prior or present bisphosphonate therapy (33)
•Prior or present calcium or vitamin D therapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified