The Clinical Features and Pregnancy Outcomes of RA Patients

Rheumatoid Arthritis Clinical Trial

Official title:

The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05651373
• Other study ID #: RA with Pregnancy QiluH
• Status: Recruiting
• Start date: July 30, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2022
• Source: Qilu Hospital of Shandong University
• Contact: Qiang Shu
• Phone: 0086-0531-82169654
• Email: shuqiang[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: August 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Pregnancy Related
• Rheumatoid Arthritis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Qilu Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Early fetal loss	Spontaneous pregnancy loss within 10 weeks of gestation	within 10 weeks of gestation
Secondary	Late fetal loss	Spontaneous pregnancy loss after 10 weeks of gestation	after 10 weeks of gestation
Secondary	Still birth	Spontaneous pregnancy loss after 10 weeks of gestation.	after 10 weeks of gestation
Secondary	Preterm delivery	Live birth before 37 weeks of gestation.	between 28 and 37 weeks of gestation
Secondary	Low-weight birth	newborns with low weight (<2500g)	after 28 weeks of gestation
Secondary	Premature rupture of membranes	the number of participants complicated with placental abruption	after 28 weeks of gestation
Secondary	Placental abruption	the number of participants complicated with placental abruption	after 28 weeks of gestation
Secondary	Fetal growth retardation (FGR)	weight below the 10th percentile for the gestational age	after 12 weeks of gestation
Secondary	Number of participants with low amniotic fluid during pregnancy	the number of participants whose B-ultrasound indicates low amniotic fluid during pregnancy	after 12 weeks of gestation
Secondary	Number of participants with abnormal S / D values during pregnancy	the number of participants whose B-ultrasound indicates abnormal S / D values during pregnancy	after 12 weeks of gestation
Secondary	Number of participants with placental hematoma during pregnancy	the number of participants whose B-ultrasound indicates placental hematoma during pregnancy	during pregnancy
Secondary	Eclampsia	New-onset hypertension after 20 weeks of gestation, with or without proteinuria > 300mg/24h, with or without any organ damage with seizures	after 20 weeks of gestation
Secondary	Gestational diabetes	the number of participants who were diagnosed with gestational diabetes	through study completion, an average of 10 months
Secondary	Gestational hypertension	the number of participants who were diagnosed with gestational hypertension	through study completion, an average of 10 months
Secondary	Number of participants with placental infarction	the number of participants whose placenta with infarction.	at delivery
Secondary	Change From Baseline in C-reactive Protein (CRP)	Change from Baseline in C-reactive Protein (CRP), CRP will be measured with blood samples.	through study completion, an average of 10 months
Secondary	Erythrocyte Sedimentation Rate (ESR)	Change from Baseline in Erythrocyte Sedimentation Rate (ESR), ESR will be measured with blood samples.	through study completion, an average of 10 months
Secondary	Live birth rate	Percentage of all patients that lead to live birth after 28 weeks of gestation	After 28 weeks of gestation
Secondary	Change from baseline Simplified Disease Activity Index (SDAI)	SDAI score exceeding 26 is considered high disease activity; 11	through study completion, an average of 10 months
Secondary	Change from baseline Clinical Disease Activity Index (CDAI)	CDAI > 22 is considered high disease activity; 10	through study completion, an average of 10 months
Secondary	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.	through study completion, an average of 10 months
Secondary	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.	through study completion, an average of 10 months
Secondary	patient global assessment(PGA)	patient global assessment(PGA)	through study completion, an average of 10 months
Secondary	Health Assessment Questionnaire (HAQ)	Health Assessment Questionnaire (HAQ)	through study completion, an average of 10 months
Secondary	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.	through study completion, an average of 10 months