RECRUITING

CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry

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Conditions

Systemic Lupus ErythematosusSLELupus

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Prospective, observational registry for subjects with SLE under the care of a rheumatology provider. Longitudinal data are collected from both subjects and their treating rheumatology provider during routine clinical encounters using a structured and standardized data collection method.

Official Title

CorEvitas Systemic Lupus Erythematosus (SLE) Drug Safety and Effectiveness Registry

Quick Facts

Study Start:2024-09-26
Study Completion:2099-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06804057

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Has been diagnosed with SLE by a rheumatologist or a qualified rheumatology practitioner.
  2. 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. 3. Willing and able to provide informed consent.
  4. 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. 5. In addition, subjects must meet at least one of the following criteria:
  6. * New diagnosis of SLE (=\<12 months) from registry enrollment, OR
  7. * Initiation of a biologic or immunosuppressant for the treatment of SLE at registry enrollment, OR
  8. * Lupus Nephritis (LN; class III-V) diagnosed within 2 years of registry enrollment
  1. 1. Is participating in a double-blind clinical trial for a SLE drug
  2. 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

Contacts and Locations

Study Contact

CorEvitas, LLC
CONTACT
(508) 408-5435
corevitasregistrytrials@corevitas.com

Study Locations (Sites)

CorEvitas
Waltham, Massachusetts, 02451
United States

Collaborators and Investigators

Sponsor: CorEvitas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-26
Study Completion Date2099-12-31

Study Record Updates

Study Start Date2024-09-26
Study Completion Date2099-12-31

Terms related to this study

Keywords Provided by Researchers

  • Systemic Lupus Erythematosus
  • SLE
  • Lupus

Additional Relevant MeSH Terms

  • Systemic Lupus Erythematosus