The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The percentage of patients who achieve clinical remission using DAS28-CRP
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •1.Age between 20 and 45 years old.
- •2.Diagnosis of RA: Approved by the American College of Rheumatology and the European League Against Rheumatism in
- •Involved joints 1 large joint (0 points) 2-10 large joints (1 point) 1-3 small joints (with or without large joints) (2 points) 4-10 small joints (with or without large joints) (3 points) more than 10 small joints (at least one small joint) (5 points)
- •Serological indicators RF and ACPA negative (0 points) RF and ACPA, at least one of which is low titer positive. (2 points) RF and ACPA with at least one high titer positive (3 points)
- •Acute chronotropic reactants Both CRP and ESR normal (0 points) Abnormal CRP or ESR (1 point)
- •Duration of synovitis <6 weeks (0 points)
- •≥6 weeks (1 point)
- •3.Voluntary participation in this study, willingness to administer medication and follow up according to the treatment plan, and signing of an informed consent form.
排除标准
- •Women who meet any of the following criteria will be excluded from the study
- •Any known etiology of previous pregnancy loss
- •Known paternal, maternal or embryonic chromosomal abnormalities.
- •Maternal endocrine dysfunction: luteal insufficiency; polycystic ovary syndrome; premature ovarian failure (follicular phase stimulating hormone, FSH ≥ 20uU/L).
- •Hyperprolactinemia; diabetes mellitus; other abnormalities of the hypothalamic pituitary-adrenal axis.
- •Maternal anatomical abnormalities: uterine malformations; Asherman syndrome; cervical insufficiency; uterine fibrosis greater than 5 cm. vaginal infection.
- •Any known serious cardiac, hepatic, renal, hematologic or endocrine disease.
- •Any active infection, including bacterial, alisla virus (VZV), human immunodeficiency virus (HIV), human papillomavirus (HPV), syphilis, tuberculosis, fungal infections, etc.
- •Hypersensitivity to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin
- •History of the following diseases.
- •Past history of peptic ulcer or upper gastrointestinal bleeding.
- •Past history of malignancy.
- •Past history of epilepsy or mental disorder.
- •Female has been diagnosed with SLE
- •Women who do not consent or are unable to complete pregnancy and postpartum follow-up.
研究组 & 干预措施
patients not using TNF inhibitors(TNFi)
The cohort includes the RA patients in pregnancy.
Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone(Pred)，5-30mg, po, once per day (qd) prescribed at the beginning and adjusted due to patient response.
干预措施: Prednisone (Drug)
patients not using TNF inhibitors(TNFi)
The cohort includes the RA patients in pregnancy.
Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone(Pred)，5-30mg, po, once per day (qd) prescribed at the beginning and adjusted due to patient response.
干预措施: Hydroxychloroquine (Drug)
patients using TNF inhibitor (TNFi)
The cohort includes the RA patients in pregnancy.
Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone(Pred)，5-30mg, po, once per day (qd) prescribed at the beginning and adjusted due to patient response.
Drug: TNFi ,such as Certolizumab Pegol (Cimzia)，200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.
干预措施: Prednisone (Drug)
patients using TNF inhibitor (TNFi)
The cohort includes the RA patients in pregnancy.
Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone(Pred)，5-30mg, po, once per day (qd) prescribed at the beginning and adjusted due to patient response.
Drug: TNFi ,such as Certolizumab Pegol (Cimzia)，200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.
干预措施: Hydroxychloroquine (Drug)
patients using TNF inhibitor (TNFi)
The cohort includes the RA patients in pregnancy.
Drug: Hydroxychloroquine(HCQ)，200mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response.
Drug: Prednisone(Pred)，5-30mg, po, once per day (qd) prescribed at the beginning and adjusted due to patient response.
Drug: TNFi ,such as Certolizumab Pegol (Cimzia)，200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.
干预措施: CertolizumabPegol injection (Drug)
结局指标
主要结局
The percentage of patients who achieve clinical remission using DAS28-CRP
时间窗: through study completion, an average of 10 months
The percentage of patients whose DAS28 achieve remission（DAS28-CRP≤ 2.6）and Low Disease Activity (DAS28-CRP ≤3.2) .
次要结局
- Early fetal loss(within 10 weeks of gestation)
- Still birth(after 10 weeks of gestation)
- Low-weight birth(after 28 weeks of gestation)
- Number of participants with low amniotic fluid during pregnancy(after 12 weeks of gestation)
- swollen joint number (SW28)(through study completion, an average of 10 months)
- Premature rupture of membranes(after 28 weeks of gestation)
- Eclampsia(after 20 weeks of gestation)
- tenderness joint number (T28)(through study completion, an average of 10 months)
- patient global assessment(PGA)(through study completion, an average of 10 months)
- Placental abruption(after 28 weeks of gestation)
- Gestational diabetes(through study completion, an average of 10 months)
- Erythrocyte Sedimentation Rate (ESR)(through study completion, an average of 10 months)
- Live birth rate(After 28 weeks of gestation)
- Change from baseline Clinical Disease Activity Index (CDAI)(through study completion, an average of 10 months)
- Percentage of patients achieving Boolean remission(through study completion, an average of 10 months)
- Late fetal loss(after 10 weeks of gestation)
- Number of participants with abnormal S / D values during pregnancy(after 12 weeks of gestation)
- Preterm delivery(between 28 and 37 weeks of gestation)
- Fetal growth retardation (FGR)(after 12 weeks of gestation)
- Number of participants with placental hematoma during pregnancy(during pregnancy)
- Gestational hypertension(through study completion, an average of 10 months)
- Number of participants with placental infarction(at delivery)
- Change From Baseline in C-reactive Protein (CRP)(through study completion, an average of 10 months)
- Change from baseline Simplified Disease Activity Index (SDAI)(through study completion, an average of 10 months)
- Health Assessment Questionnaire (HAQ)(through study completion, an average of 10 months)
研究者
Qiang Shu
Chief Physician
Qilu Hospital of Shandong University