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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT02890134
Eligibility Criteria:
Inclusion Criteria:
* · Aged 18 years or older at the time of consent
* Diagnosed according to prevailing criteria for one of the following systemic autoimmune diseases (see Annex 2)
* Rheumatoid arthritis (RA)
* Scleroderma or systemic sclerosis (SSc)
* Primary Sjögren's syndrome (SjS)
* Systemic lupus erythematosus (SLE)
* Primary antiphospholipid syndrome (PAPS)
* Mixed Connective Tissue Disease (MCTD)
* Patients with undifferentiated connective tissue disease (UCTD) for over 1 year and that do not fulfill the diagnosis of any of the above diseases.
* Signed the informed consent form
Exclusion Criteria:
* · Patients unable to understand the procedures related to the protocol should not be included. The study is voluntary and patients must be able to give their informed consent.
* Pregnant women
* Neonatal lupus
* Drug-induced lupus
* Patients whose condition is so serious that they cannot take part in the study
* Severe nephrotic syndrome with proteinuria \>=3,5 g/day
* Patients with stable doses of steroids \>15mg/day for the last 3 months or with IV corticosteroids in the last 3 months
* Patients under immunosuppressants for the last 3 months prior to recruitment with:
* Methotrexate ≥25mg/week
* Azathioprine ≥2.5mg/kg/day
* Cyclosporine A \> 3mg/kg/day
* Mycophenolate Mofetil \> 2gr/day
* Treatment with cyclophosphamide (any dose or route of administration) or Belimumab in the past 6 months
* Patients with combined therapy of two or more immunosuppressants
* Patients on depletative therapy such as Rituximab in the last year
* Patients receiving experimental
* Overlap syndromes
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02890134
Study Brief:
Protocol Section:
NCT02890134