The Clinical Features and Pregnancy Outcomes of RA Patients

Shandong University

Status: Enrolling

Conditions: Pregnancy Related; Rheumatoid Arthritis

Treatments: Drug: Prednisone; Drug: CertolizumabPegol injection; Drug: Hydroxychloroquine

Study type: Observational

Funder types: Other

Identifiers

NCT05651373

RA with Pregnancy QiluH

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 estimated patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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

  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.

Trial design

100 participants in 2 patient groups

patients not using TNF inhibitors(TNFi)

Description:

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.

Treatment:

Drug: Hydroxychloroquine

Drug: Prednisone

patients using TNF inhibitor (TNFi)

Description:

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.

Treatment:

Drug: Hydroxychloroquine

Drug: CertolizumabPegol injection

Drug: Prednisone