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:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT06804057
Eligibility Criteria:
Inclusion Criteria:
To be eligible to participate in this registry, an individual must meet all the following criteria:
1. Has been diagnosed with SLE by a rheumatologist or a qualified rheumatology practitioner.
2. Is at least 18 years of age or older and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted at the time of enrollment.
3. Willing and able to provide informed consent.
4. Willing and able to provide Personally Identifiable Information (full legal name, sex at birth, date of birth, and home address zip/postal code at a minimum) if required based on registry location and applicable laws and regulations.
5. In addition, subjects must meet at least one of the following criteria:
* New diagnosis of SLE (=\<12 months) from registry enrollment, OR
* Initiation of a biologic or immunosuppressant for the treatment of SLE at registry enrollment, OR
* Lupus Nephritis (LN; class III-V) diagnosed within 2 years of registry enrollment
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in the registry:
1. Is participating in a double-blind clinical trial for a SLE drug
2. Subjects participating in any non-blinded trial for any indication, with the exception of non-blinded CAR-T or other cell/gene therapies for the treatment of SLE
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06804057
Study Brief:
Protocol Section:
NCT06804057