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ABOUT THIS STUDY
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.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Systemic Lupus Erythematosus
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
6 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
-
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Advanced Information
| Descriptive Information | |||
|---|---|---|---|
| Brief Title | Web-based Genetic Research on Lupus | ||
| Official Title | Not Provided | ||
| 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. | ||
| Detailed 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/ | ||
| Study Type | Observational | ||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | ||
| Target Follow-Up Duration | Not Provided | ||
| Biospecimen | Retention: Samples With DNA Description: Saliva samples are collected for DNA analysis | ||
| Sampling Method | Non-Probability Sample | ||
| Study Population | Community Sample | ||
| Condition | Systemic Lupus Erythematosus | ||
| Intervention | Not Provided | ||
| Study Groups/Cohorts | Lupus patients
People diagnosed with Systemic Lupus Erythematosus by a physician | ||
| Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status | Completed | ||
| Actual Enrollment | 5000 | ||
| Original Estimated Enrollment | Same as current | ||
| Actual Study Completion Date | October 31, 2017 | ||
| Actual Primary Completion Date | October 31, 2017 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: - | ||
| Sex/Gender |
| ||
| Ages | 6 Years and older (Child, Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT02530944 | ||
| Other Study ID Numbers | 23andMe_SLE001 | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | 23andMe, Inc. | ||
| Study Sponsor | 23andMe, Inc. | ||
| Collaborators | Pfizer | ||
| Investigators | Not Provided | ||
| PRS Account | 23andMe, Inc. | ||
| Verification Date | January 2018 | ||