The Clinical Features and Pregnancy Outcomes of RA Patients
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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. |
Drug: Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Other Names:
Drug: Hydroxychloroquine
200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names:
|
| 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. |
Drug: Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Other Names:
Drug: Hydroxychloroquine
200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
Other Names:
Drug: CertolizumabPegol injection
200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- The percentage of patients who achieve clinical remission using DAS28-CRP [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) .
Secondary Outcome Measures
- Early fetal loss [within 10 weeks of gestation]
Spontaneous pregnancy loss within 10 weeks of gestation
- Late fetal loss [after 10 weeks of gestation]
Spontaneous pregnancy loss after 10 weeks of gestation
- Still birth [after 10 weeks of gestation]
Spontaneous pregnancy loss after 10 weeks of gestation.
- Preterm delivery [between 28 and 37 weeks of gestation]
Live birth before 37 weeks of gestation.
- Low-weight birth [after 28 weeks of gestation]
newborns with low weight (<2500g)
- Premature rupture of membranes [after 28 weeks of gestation]
the number of participants complicated with placental abruption
- Placental abruption [after 28 weeks of gestation]
the number of participants complicated with placental abruption
- Fetal growth retardation (FGR) [after 12 weeks of gestation]
weight below the 10th percentile for the gestational age
- Number of participants with low amniotic fluid during pregnancy [after 12 weeks of gestation]
the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy
- Number of participants with abnormal S / D values during pregnancy [after 12 weeks of gestation]
the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy
- Number of participants with placental hematoma during pregnancy [during pregnancy]
the number of participants whose B-ultrasound indicates placental hematoma during pregnancy
- Eclampsia [after 20 weeks of gestation]
New-onset hypertension after 20 weeks of gestation, with or without proteinuria > 300mg/24h, with or without any organ damage with seizures
- Gestational diabetes [through study completion, an average of 10 months]
the number of participants who were diagnosed with gestational diabetes
- Gestational hypertension [through study completion, an average of 10 months]
the number of participants who were diagnosed with gestational hypertension
- Number of participants with placental infarction [at delivery]
the number of participants whose placenta with infarction.
- Change From Baseline in C-reactive Protein (CRP) [through study completion, an average of 10 months]
Change from Baseline in C-reactive Protein (CRP), CRP will be measured with blood samples.
- Erythrocyte Sedimentation Rate (ESR) [through study completion, an average of 10 months]
Change from Baseline in Erythrocyte Sedimentation Rate (ESR), ESR will be measured with blood samples.
- Live birth rate [After 28 weeks of gestation]
Percentage of all patients that lead to live birth after 28 weeks of gestation
- Change from baseline Simplified Disease Activity Index (SDAI) [through study completion, an average of 10 months]
SDAI score exceeding 26 is considered high disease activity; 11 <SDAI ≤26，moderate disease activity; 3.3 <SDAI ≤11, low disease activity; remission is SDAI score ≤ 3.3.
- Change from baseline Clinical Disease Activity Index (CDAI) [through study completion, an average of 10 months]
CDAI > 22 is considered high disease activity; 10 <CDAI ≤ 22, moderate disease activity; 2.8 <CDAI ≤10, low disease activity; remission is CDAI score ≤2.8.
- swollen joint number (SW28) [through study completion, an average of 10 months]
SW28 means the number of joints with swelling counted in 28 synovial joints, including proximal interphalangeal joints (10 joints), metacarpophalangeal joints (10), wrists (2), elbows (2), shoulders (2) and knees (2) bilateral.
- tenderness joint number (T28) [through study completion, an average of 10 months]
T28 means the number of joints with tenderness upon touching counted in 28 synovial joints, including proximal interphalangeal joints (10 joints), metacarpophalangeal joints (10), wrists (2), elbows (2), shoulders (2) and knees (2) bilateral.
- patient global assessment(PGA) [through study completion, an average of 10 months]
patient global assessment(PGA)
- Health Assessment Questionnaire (HAQ) [through study completion, an average of 10 months]
Health Assessment Questionnaire (HAQ)
- Percentage of patients achieving Boolean remission [through study completion, an average of 10 months]
Clinical remission was defined when the number of swollen joints ≤1, the number of painful joints ≤1, CRP ≤1 mg/dl and the patient's overall score of the disease ≤1 were also satisfied.
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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 2010.
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.
Exclusion Criteria:
- Women who meet any of the following criteria will be excluded from the study
-
Any known etiology of previous pregnancy loss
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Known paternal, maternal or embryonic chromosomal abnormalities.
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Maternal endocrine dysfunction: luteal insufficiency; polycystic ovary syndrome; premature ovarian failure (follicular phase stimulating hormone, FSH ≥ 20uU/L).
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Hyperprolactinemia; diabetes mellitus; other abnormalities of the hypothalamic pituitary-adrenal axis.
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Maternal anatomical abnormalities: uterine malformations; Asherman syndrome; cervical insufficiency; uterine fibrosis greater than 5 cm. vaginal infection.
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Any known serious cardiac, hepatic, renal, hematologic or endocrine disease.
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Any active infection, including bacterial, alisla virus (VZV), human immunodeficiency virus (HIV), human papillomavirus (HPV), syphilis, tuberculosis, fungal infections, etc.
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Hypersensitivity to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin
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History of the following diseases.
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Past history of peptic ulcer or upper gastrointestinal bleeding.
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Past history of malignancy.
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Past history of epilepsy or mental disorder.
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Female has been diagnosed with SLE
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Women who do not consent or are unable to complete pregnancy and postpartum follow-up.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Qilu Hospital | Jinan | Shandong | China | Shandong |
Sponsors and Collaborators
- Qilu Hospital of Shandong University
Investigators
- Study Director: Xiaoyun Yang, Qilu Hospital of Shandong University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RA with Pregnancy QiluH