The Clinical Features and Pregnancy Outcomes of RA Patients
NCT ID: NCT05651373
Last Updated: 2022-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2021-07-30
2024-12-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Hydroxychloroquine
200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
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.
Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Hydroxychloroquine
200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
CertolizumabPegol injection
200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.
Interventions
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Prednisone
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Hydroxychloroquine
200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
CertolizumabPegol injection
200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
1. Any known etiology of previous pregnancy loss
1. Known paternal, maternal or embryonic chromosomal abnormalities.
2. Maternal endocrine dysfunction: luteal insufficiency; polycystic ovary syndrome; premature ovarian failure (follicular phase stimulating hormone, FSH ≥ 20uU/L).
3. Hyperprolactinemia; diabetes mellitus; other abnormalities of the hypothalamic pituitary-adrenal axis.
4. Maternal anatomical abnormalities: uterine malformations; Asherman syndrome; cervical insufficiency; uterine fibrosis greater than 5 cm. vaginal infection.
5. Any known serious cardiac, hepatic, renal, hematologic or endocrine disease.
2. Any active infection, including bacterial, alisla virus (VZV), human immunodeficiency virus (HIV), human papillomavirus (HPV), syphilis, tuberculosis, fungal infections, etc.
3. Hypersensitivity to prednisone, hydroxychloroquine, low molecular weight heparin or aspirin
4. History of the following diseases.
1. Past history of peptic ulcer or upper gastrointestinal bleeding.
2. Past history of malignancy.
3. Past history of epilepsy or mental disorder.
4. Female has been diagnosed with SLE
5. Women who do not consent or are unable to complete pregnancy and postpartum follow-up.
20 Years
45 Years
FEMALE
No
Sponsors
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Qilu Hospital of Shandong University
OTHER
Responsible Party
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Qiang Shu
Chief Physician
Principal Investigators
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Xiaoyun Yang
Role: STUDY_DIRECTOR
Qilu Hospital of Shandong University
Locations
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Qilu Hospital
Jinan, Shandong, China
Countries
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Central Contacts
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Facility Contacts
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Xiaoyun Yang
Role: primary
Other Identifiers
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RA with Pregnancy QiluH
Identifier Type: -
Identifier Source: org_study_id