Web-based Genetic Research on Lupus

Systemic Lupus Erythematosus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02530944
• Other study ID #: 23andMe_SLE001
• Status: Completed
• Phase: N/A
• First received: August 18, 2015
• Last updated: January 8, 2018
• Start date: May 2015
• Est. completion date: October 31, 2017

Study information

• Verified date: January 2018
• Source: 23andMe, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator's partners at Pfizer.

Description:

Lupus is a difficult disease to diagnose and one that's difficult to manage, given the lack of specific medicines to treat lupus and the side-effects of current medications. The investigators believe genetics may play a critical role in developing better lupus diagnoses and treatments. If individuals are eligible to participate, the investigators will send a 23andMe DNA saliva kit at no cost. Participants will be asked to take a 15 minute online survey with questions about their lupus experience, symptoms and response to treatments, in addition to five additional bi-monthly short surveys and one final study survey during the 12-month participation. Learn more and join the lupus study today: https://www.23andme.com/lupus/

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5000
• Est. completion date: October 31, 2017
• Est. primary completion date: October 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• diagnosed with lupus by a qualified physician.

• consents to have 23andMe (via a partner) contact the physician to obtain medical record information

• willing to submit a saliva sample for DNA testing and complete online surveys related to condition

• at least 6 years old (minors under 18 require parental consent to enroll)

• access to the internet

• resides in the United States

Exclusion Criteria:

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
United States	Www.23Andme.Com/Lupus	Mountain View	California

Sponsors (2)

Lead Sponsor	Collaborator
23andMe, Inc.	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary DNA sample for genetic analysis		12 months
Primary	Online survey	Questions about lupus experience, symptoms and response to treatment	12 months