NCT02530944

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

August 18, 2015

Last Update Submit

January 8, 2018

Conditions

Systemic Lupus Erythematosus

Keywords

LupusSystemic Lupus Erythematosus (SLE)geneticonlinegenome wide associationsystemic lupus erythematosusgenome wide association study (GWAS)

Outcome Measures

Primary Outcomes (2)

  • Salivary DNA sample for genetic analysis

    12 months

  • Online survey

    Questions about lupus experience, symptoms and response to treatment

    12 months

Study Arms (1)

Lupus patients

People diagnosed with Systemic Lupus Erythematosus by a physician

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community Sample

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Www.23Andme.Com/Lupus

Mountain View, California, 94041, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples are collected for DNA analysis

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 18, 2015

First Posted

August 21, 2015

Study Start

May 1, 2015

Primary Completion

October 31, 2017

Study Completion

October 31, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations

US(1)