The Clinical Features and Pregnancy Outcomes of RA Patients

NCT05651373 | Unknown

• 1 other identifier: RA with Pregnancy QiluH
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Pregnancy Related

Keywords

Rheumatoid Arthritis; Pregnancy outcomes; Clinical features; Risk factors

Outcome Measures

Primary Outcomes (1)

• The percentage of patients who achieve clinical remission using DAS28-CRP

  The percentage of patients whose DAS28 achieve remission（DAS28-CRP≤ 2.6）and Low Disease Activity (DAS28-CRP ≤3.2) .

  through study completion, an average of 10 months

Secondary Outcomes (25)

• Early fetal loss

  within 10 weeks of gestation

• Late fetal loss

  after 10 weeks of gestation

• Still birth

  after 10 weeks of gestation

• Preterm delivery

  between 28 and 37 weeks of gestation

• Low-weight birth

  after 28 weeks of gestation

Study Arms (2)

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; Drug: Hydroxychloroquine

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; Drug: Hydroxychloroquine; Drug: CertolizumabPegol injection

Interventions

Prednisone DRUG

5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response

Also known as: Pred

patients not using TNF inhibitors(TNFi); patients using TNF inhibitor (TNFi)

Hydroxychloroquine DRUG

200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.

Also known as: HCQ

patients not using TNF inhibitors(TNFi); patients using TNF inhibitor (TNFi)

CertolizumabPegol injection DRUG

200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.

Also known as: Cimzia

patients using TNF inhibitor (TNFi)

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

female with pregnance in accordance with the diagnostic criteria of Rheumatoid arthritis in 2010.

You may qualify if:

• \- 1.Age between 20 and 45 years old.
• 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)
• Voluntary participation in this study, willingness to administer medication and follow up according to the treatment plan, and signing of an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital

Jinan, Shandong, Shandong, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Early, intermediate and late peripheral blood specimens、cord blood specimens、placental tissue

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Prednisone; prednylidene; Hydroxychloroquine; Certolizumab Pegol

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Xiaoyun Yang

  Qilu Hospital of Shandong University

  STUDY DIRECTOR

Central Study Contacts

Qiang Shu

CONTACT

0086-0531-82169654; shuqiang@sdu.edu.cn

Bingbing Ren

CONTACT

+8618765361979; sdrenbingbing@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 15, 2022
• Study Start: July 30, 2021
• Primary Completion: August 30, 2023
• Study Completion: December 31, 2024
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)