NCT04569890

Treatment of Pregnancy RA

Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

It is important to control the disease of pregnant women with rheumatoid arthritis to ensure the fetal and maternal health. Frequent disease flare can increase the risk of adverse pregnancy outcomes, including abortion, premature delivery and low birth weight. However, there is no scientific and standardized treatment strategy for RA during pregnancy. About 50% of RA patients need treatment during pregnancy. Tumor necrosis inhibitor (TNFi) is an effective treatment, which can significantly improve the symptoms of RA during pregnancy. However, in order to avoid placental metastasis, TNFi is usually stopped in early pregnancy. Certolizumab pegol (CZP) is a PEGylated, Fc-free TNFi, which does not bind FcRn and is consequently not expected to undergo FcRn-mediated transfer across the placenta. Therefore, it can not transfer through placenta into FcRn and is approved to treat RA during pregnancy. This study focuses on patients with RA who consider pregnancy. We compared the efficacy, safety and economy of CZP and glucocorticoids combined with hydroxychloroquine by a randomized controlled trial.

Detailed description

In this study, a randomized controlled study was conducted to compare the efficacy, safety and economy of CZP and glucocorticoids combined with hydroxychloroquine in the treatment of RA patients who consider pregnancy. Informed consent must be obtained for the patients to be screened. Random method: central random. Blinding method: assessor and data analyst blindness. Follow-up: every 4 week. First endpoint: 24 week. Second endpoint: 52 week. Safety endpoint: 24 weeks postpartum. Missing data: core data related to treatment and disease activity are not allowed to be missing, and other data are supplemented by the last observation value.

Conditions

• Rheumatoid Arthritis
• Pregnancy Related

Interventions

Type	Name	Description
DRUG	Certolizumab Pegol 200 MG/ML [Cimzia]	CZP 200mg twice a week subcutaneous.
DRUG	Hydroxychloroquine	400mg HCQ orally daily
DRUG	Prednisone	10mg GC orally daily

Timeline

• Start date: 2020-12-01
• Primary completion: 2022-12-01
• Completion: 2023-12-01
• First posted: 2020-09-30
• Last updated: 2020-10-01

Locations

1 site across 1 country: China