The Clinical Features and Pregnancy Outcomes of RA Patients

Qilu Hospital of Shandong University100 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

100

Conditions

Rheumatoid Arthritis Pregnancy Related

Interventions

PrednisoneDRUG

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

HydroxychloroquineDRUG

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

CertolizumabPegol injectionDRUG

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

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

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.

Locations (1)

Qilu Hospital

Jinan, Shandong, China

RECRUITING

Outcomes

Primary Outcomes

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) .

Time frame: through study completion, an average of 10 months

Secondary Outcomes

Early fetal loss

Spontaneous pregnancy loss within 10 weeks of gestation

Time frame: within 10 weeks of gestation

Late fetal loss

Spontaneous pregnancy loss after 10 weeks of gestation

Time frame: after 10 weeks of gestation

Still birth

Spontaneous pregnancy loss after 10 weeks of gestation.

Time frame: after 10 weeks of gestation

Preterm delivery

Live birth before 37 weeks of gestation.

Time frame: between 28 and 37 weeks of gestation

Low-weight birth

newborns with low weight (\<2500g)

Time frame: after 28 weeks of gestation

Premature rupture of membranes

the number of participants complicated with placental abruption

Time frame: after 28 weeks of gestation

Placental abruption

the number of participants complicated with placental abruption

Time frame: after 28 weeks of gestation

Central Contacts

Qiang Shu

CONTACT

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

Bingbing Ren

CONTACT

+8618765361979 sdrenbingbing@163.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Fetal growth retardation (FGR)

weight below the 10th percentile for the gestational age

Time frame: after 12 weeks of gestation

Number of participants with low amniotic fluid during pregnancy

the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy

Time frame: after 12 weeks of gestation

Number of participants with abnormal S / D values during pregnancy

the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy

Time frame: after 12 weeks of gestation

Number of participants with placental hematoma during pregnancy

the number of participants whose B-ultrasound indicates placental hematoma during pregnancy

Time frame: during pregnancy

Eclampsia

New-onset hypertension after 20 weeks of gestation, with or without proteinuria \> 300mg/24h, with or without any organ damage with seizures

Time frame: after 20 weeks of gestation

Gestational diabetes

the number of participants who were diagnosed with gestational diabetes

Time frame: through study completion, an average of 10 months

Gestational hypertension

the number of participants who were diagnosed with gestational hypertension

Time frame: through study completion, an average of 10 months

Number of participants with placental infarction

the number of participants whose placenta with infarction.

Time frame: at delivery

Change From Baseline in C-reactive Protein (CRP)

Change from Baseline in C-reactive Protein (CRP), CRP will be measured with blood samples.

Time frame: through study completion, an average of 10 months

Erythrocyte Sedimentation Rate (ESR)

Change from Baseline in Erythrocyte Sedimentation Rate (ESR), ESR will be measured with blood samples.

Time frame: through study completion, an average of 10 months

Live birth rate

Percentage of all patients that lead to live birth after 28 weeks of gestation

Time frame: After 28 weeks of gestation

Change from baseline Simplified Disease Activity Index (SDAI)

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.

Time frame: through study completion, an average of 10 months

Change from baseline Clinical Disease Activity Index (CDAI)

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.

Time frame: through study completion, an average of 10 months

swollen joint number (SW28)

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.

Time frame: through study completion, an average of 10 months

tenderness joint number (T28)

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.

Time frame: through study completion, an average of 10 months

patient global assessment(PGA)

Time frame: through study completion, an average of 10 months

Health Assessment Questionnaire (HAQ)

Time frame: through study completion, an average of 10 months

Percentage of patients achieving Boolean remission

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.

Time frame: through study completion, an average of 10 months