Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Disease Activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Assessor and data analyst blindness. To avoid bias, physicians who assess disease activity will be blinded. Participants are required not to discuss their treatment allocation with physicians at each visit. The success of the blind method will be judged by requiring the assessors to determine the treatment allocation of participants after each visit. When the database is locked, the statistician will carry on the data analysis in the hidden of allocation.
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of RA, as defined by 2010 ACR/EULAR criteria
- •DAS 28∙ESR<2.6 under the treatment of DMARDs
- •Subjects consider pregnancy, but not pregnant yet
- •Participant expects to continue CZP therapy throughout pregnancy and for at least 24 weeks postpartum
- •Participant has a negative interferon gamma release assay (IGRA) or tuberculin skin test (TST) within the prior 6 months, and there has been no change in the study participant's clinical status, or social, family, or travel history. Participants with documented Bacillus Calmette-Guérin (BCG) vaccine and at low risk for tuberculosis (TB) may enroll without having a TB test performed
排除标准
- •Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study
- •Participant is not permitted to enroll into the study if she meets any of the following TB exclusion criteria:(1) Known active TB disease; (2) History of active TB involving any organ system; (3) Latent TB infection; (4) High risk of acquiring TB infection; (5) Current nontuberculous mycobacterial (NTM) infection or history of NTM infection (unless proven to be fully recovered)
- •Study participant is taking a prohibited medication or has taken a prohibited medication
- •Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study
- •Study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator
- •Study participant had a positive or indeterminate interferon gamma release assay (IGRA) or tuberculin skin test (TST) at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the study participant
研究组 & 干预措施
CZP
Certolizumab pegol: subcutaneous CZP at 200mg twice a week.
干预措施: Certolizumab Pegol 200 MG/ML [Cimzia] (Drug)
GC+HCQ
Hydroxychloroquine: HCQ at 200mg daily, and if tolerated, escalated to 400 mg daily.
Glucocorticoid: continuous usage GC at 10mg a day from Week 0 to Week 52.
At 24 week, non-responders (ΔDAS28<0.6) will switch to the other group. Participants switched to CZP group will taper their dose of GC gradually, if they have an improvement in disease activity (two successive DAS28<2.6). If participants have a disease flare (increased DAS28>0.6) during a reduction in corticosteroid dose, then they will resume their previous dose. Weekly step-down GC scheme: 10mg-7.5mg-5mg-2.5mg-0mg.
干预措施: Hydroxychloroquine (Drug)
GC+HCQ
Hydroxychloroquine: HCQ at 200mg daily, and if tolerated, escalated to 400 mg daily.
Glucocorticoid: continuous usage GC at 10mg a day from Week 0 to Week 52.
At 24 week, non-responders (ΔDAS28<0.6) will switch to the other group. Participants switched to CZP group will taper their dose of GC gradually, if they have an improvement in disease activity (two successive DAS28<2.6). If participants have a disease flare (increased DAS28>0.6) during a reduction in corticosteroid dose, then they will resume their previous dose. Weekly step-down GC scheme: 10mg-7.5mg-5mg-2.5mg-0mg.
干预措施: Prednisone (Drug)
结局指标
主要结局
Disease Activity
时间窗: 24 week
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.
次要结局
- Time to pregnancy(52 week)
- ACR20(52 week)
- ACR50(52 week)
- ACR70(52 week)
- Time to remission(52 week)
- EQ-5D(52 week)
- MHAQ(52 week)
- Pregnancy rate(52 week)
- Pregnancy outcomes(0-52 week)