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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Renji Hospital
Shanghai, Shanghai Municipality, China
Disease Activity
Proportion of DAS28 remission. In principle, the score of das28-esr should be used. If there is data missing, das28-crp can be used. All patients have either complete das28-esr data or complete das28-crp data.
Time frame: 24 week
ACR20
Proportion of ACR20 improvement.
Time frame: 52 week
ACR50
Proportion of ACR50 improvement.
Time frame: 52 week
ACR70
Proportion of ACR70 improvement.
Time frame: 52 week
Time to remission
Time frame: 52 week
MHAQ
The Modified Health Assessment Questionnaire (MHAQ), reduced the number of items from 20 in the original HAQ to eight, and improved the feasibility in clinical practice when screening patients. The MHAQ score is calculated as the mean of the scores for each activity. Total score is between 0.0-3.0, in 0.125 increments. Higher scores indicate worse function and greater disability. MHAQ scores \<0.3 are considered normal.
Time frame: 52 week
EQ-5D
Health quality assessed by EuroQol five dimensions questionnaire. It is a preference-based measure that can be regarded as a continuous outcome scored on a -0.59 to 1.00 scale, with 1.00 indicating 'full health' and 0 representing dead.
Time frame: 52 week
Time to pregnancy
Time frame: 52 week
Pregnancy rate
Time frame: 52 week
Pregnancy outcomes
Pregnancy will end with live birth, stillbirth, spontaneous abortion or therapeutic abortion.
Time frame: 0-52 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.