Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Rheumatoid Arthritis Clinical Trial

— MADRA  

Official title:

Maternal Autoimmune Disease Research Alliance (MADRA) Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03276923
• Other study ID #: Pro00084014
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: January 1, 2027

Study information

• Verified date: January 2024
• Source: Duke University
• Contact: Laura Neil
• Phone: 919 684 8936
• Email: laura.k.neil[@]duke.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases. The main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and their babies during pregnancy. Prior studies demonstrate the importance of increase inflammation prior to and during pregnancy on these outcomes. The future research will seek to better define these risk factors and to identify ways to may improve them.

Description:

At each site, the patients will be under the care of the participating rheumatologist and their local obstetrician during the pregnancy. This is a natural-history study and will not include medications, laboratory testing, or procedures outside of the standard of care. Management of the rheumatologic disease will be directed based on patient needs by the local rheumatologist and obstetrician. Enrollment in the registry will not dictate specific therapy. The Registry will include data from each office visit during pregnancy and up to 12 months after delivery. The registry will be ongoing, with periodic analysis of clinical data samples as specific studies are approved. Enrollment in the registry does not significantly increase risks for a patient.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Diseases
• Cutaneous Lupus
• Lupus Erythematosus, Systemic
• Pregnancy Related
• Rheumatoid Arthritis
• Scleroderma
• Sjogren's Syndrome
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.	The investigators will ask the participants questions from the MADRA-DAP questionnaire to determine poor pregnancy outcomes.	up to 10 years