NCT05651373

The Clinical Features and Pregnancy Outcomes of RA Patients

The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study includes RA patients in pregnancy, who are using different treatment regimens，including prednisone, hydroxychloroquine, and/or TNF inhibitors. The maternal disease activity, pregnancy outcomes, maternal and fetal safety are assessing during the trimester of pregnancy. The effects of different therapies and risk factors for adverse pregnancy outcomes will be analysis.

Detailed description

To study the risk factors of poor pregnancy outcomes in RA patients, and evaluate impact of different therapies on the maternal and fetal health. The follow-up study will be scheduled every 4 weeks from confirmed pregnancy until delivery, records the disease activity of RA, pregnancy outcome and safety with the help of the "smart disease management system (SSDM)" and face-to-face consultations. The effects of different therapies on maternal and fetal will be valued

Conditions

• Rheumatoid Arthritis
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Prednisone	5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
DRUG	Hydroxychloroquine	200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
DRUG	CertolizumabPegol injection	200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.

Timeline

• Start date: 2021-07-30
• Primary completion: 2023-08-30
• Completion: 2024-12-31
• First posted: 2022-12-15
• Last updated: 2022-12-15

Locations

1 site across 1 country: China