ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
-
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Descriptive Information | |||
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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 |