Maternal Autoimmune Disease Research Alliance (MADRA) Registry
Launched by DUKE UNIVERSITY · Sep 7, 2017
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The Maternal Autoimmune Disease Research Alliance (MADRA) Registry is a clinical study based at Duke University that focuses on understanding how autoimmune diseases affect pregnant women and their babies. The main goal of this study is to find ways to improve the health outcomes for women with these conditions, such as lupus, rheumatoid arthritis, and scleroderma, during pregnancy. Researchers will look into how increased inflammation—an immune response that can happen before and during pregnancy—can impact both the mother and baby’s health.
To participate in this study, women must be either currently pregnant or planning to become pregnant within the next six months and have a systemic autoimmune disease, such as lupus or rheumatoid arthritis. Participants will have regular follow-up visits at Duke University and will be asked questions about their health and pregnancy. This study is currently recruiting female participants, but those who are unable to speak English or travel to the study site cannot take part. By joining the MADRA study, participants will contribute to important research that could lead to better care for women with autoimmune diseases during pregnancy.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Desire for pregnancy within 6 months or currently pregnant
- * Women with systemic autoimmune disease, including:
- • Lupus (systemic lupus erythematosus or cutaneous lupus)
- • Antiphospholipid Syndrome or positive antiphospholipid antibodies
- • Rheumatoid Arthritis
- • Scleroderma (systemic sclerosis)
- • Sjogren's Syndrome
- • Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)
- • Undifferentiated Connective Tissue Disease (UCTD)
- • Vasculitis
- • Myositis (Polymyositis or Dermatomyositis)
- • Positive Ro/SSA or La/SSB antibodies
- Exclusion Criteria:
- • Unable to speak English
- • Unable to provide informed consent
- • Unable to travel to Duke University for follow-up visits
About Duke University
Duke University, a leading academic and research institution located in Durham, North Carolina, is renowned for its commitment to advancing healthcare through innovative clinical research. With a strong emphasis on interdisciplinary collaboration, Duke conducts a wide array of clinical trials aimed at developing cutting-edge therapies and improving patient outcomes across various medical fields. The university's Clinical Research Institute provides comprehensive support for trial design, implementation, and regulatory compliance, ensuring that all research adheres to the highest ethical and scientific standards. Duke’s dedication to translating research findings into effective clinical practices underscores its role as a pivotal contributor to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Durham, North Carolina, United States
Patients applied
Trial Officials
Megan EB Clowse, MD, MPH
Principal Investigator
Duke Health
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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