Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:31 AM
Ignite Modification Date:
2025-12-25 @ 3:31 AM
NCT ID:
NCT04917705
Eligibility Criteria:
Inclusion Criteria:
* Control population without inflammatory myopathy (population 1), suspected myopathy for whom a blood test and muscle biopsy are required to confirm the diagnosis
* Confirmed inflammatory myopathy (population 2)
* Control population without systemic sclerosis (population 3), with primary Raynaud's phenomenon
* Early diffuse systemic cutaneous scleroderma (population 4)
* Male or female (age ≥ 18, no upper age limit)
Exclusion Criteria:
Populations 1 \& 2
* Contraindication to muscle biopsy
* Diagnosed for another neuromuscular disease
* Taking an immunosuppressant / immunomodulator treatment within 3 months before inclusion
* Unbalanced cardiovascular pathology
Population 3 \& 4
* Contraindication to skin biopsy
* Capillaroscopic and / or immunological anomaly suggesting scleroderma
* Suspicion of scleroderma but diagnosed for another connectivitis
* Immunosuppressive treatment (corticosteroids\> 15 mg, methotrexate, mycophenolate mofetil) introduced for more than 1 month
* Active or recent cancer \<3 years (apart from non-melanoma skin cancer).
For all
\- Pregnancy or breast feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04917705
Study Brief:
Protocol Section:
NCT04917705