Rheumatoid ArthritisNCT05651373
The Clinical Features and Pregnancy Outcomes of RA Patients
An observational study of Rheumatoid Arthritis and Pregnancy Related, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Rheumatoid Arthritis, Pregnancy Related
- What is being tested?
- Prednisone, Hydroxychloroquine and CertolizumabPegol injection
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: female with pregnance in accordance with the diagnostic criteria of Rheumatoid arthritis in 2010.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu Hospital
Jinan, Shandong, Shandong
Xiaoyun Yang, 0086-0531-82169166, qlyykyc@163.com
About this study
Official title: The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study
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.
Read the detailed 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
- Conditions
- Rheumatoid Arthritis, Pregnancy Related
- Being tested
- Prednisone, Hydroxychloroquine, CertolizumabPegol injection
- Keywords
- Rheumatoid Arthritis, Pregnancy outcomes, Clinical features, Risk factors
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
Also called Pred
5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
Also called HCQ
200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
CertolizumabPegol injectionDrug
Also called Cimzia
200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Prednisone; Drug: Hydroxychloroquine; Drug: CertolizumabPegol injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: through study completion, an average of 10 months
Secondary outcomes (25)
Early fetal loss
Spontaneous pregnancy loss within 10 weeks of gestation
Measured: within 10 weeks of gestation
Late fetal loss
Spontaneous pregnancy loss after 10 weeks of gestation
Measured: after 10 weeks of gestation
Still birth
Spontaneous pregnancy loss after 10 weeks of gestation.
Measured: after 10 weeks of gestation
Preterm delivery
Live birth before 37 weeks of gestation.
Measured: between 28 and 37 weeks of gestation
Low-weight birth
newborns with low weight (<2500g)
Measured: after 28 weeks of gestation
Premature rupture of membranes
the number of participants complicated with placental abruption
Measured: after 28 weeks of gestation
Placental abruption
the number of participants complicated with placental abruption
Measured: after 28 weeks of gestation
Fetal growth retardation (FGR)
weight below the 10th percentile for the gestational age
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: after 20 weeks of gestation
Gestational diabetes
the number of participants who were diagnosed with gestational diabetes
Measured: through study completion, an average of 10 months
Gestational hypertension
the number of participants who were diagnosed with gestational hypertension
Measured: through study completion, an average of 10 months
Number of participants with placental infarction
the number of participants whose placenta with infarction.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 10 months
patient global assessment(PGA)
patient global assessment(PGA)
Measured: through study completion, an average of 10 months
Health Assessment Questionnaire (HAQ)
Health Assessment Questionnaire (HAQ)
Measured: 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.
Measured: through study completion, an average of 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start30 Jul 2021
- Primary completion30 Aug 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang Shu, Qilu Hospital of Shandong University
- Investigators
- Xiaoyun Yang, Study director, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05651373
- Sponsor's protocol ID
- RA with Pregnancy QiluH
- Status last verified
- Dec 2022
- First submitted
- 15 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Features and Pregnancy Outcomes of Patients With Rheumatoid Arthritis :a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05651373
- Acronym / sponsor ID
- RA with Pregnancy QiluH
- Conditions
- Rheumatoid Arthritis, Pregnancy Related
- Keywords
- Rheumatoid Arthritis, Pregnancy outcomes, Clinical features, Risk factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 30 Jul 2021 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients not using TNF inhibitors(TNFi) | – | Drug: Prednisone, Drug: HydroxychloroquineThe 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. |
| patients using TNF inhibitor (TNFi) | – | Drug: Prednisone, Drug: Hydroxychloroquine, Drug: CertolizumabPegol injectionThe 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. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- female with pregnance in accordance with the diagnostic criteria of Rheumatoid arthritis in 2010.
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (15 listed)
- Women who meet any of the following criteria will be excluded from the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoneAlso: Pred5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response | Drug | patients not using TNF inhibitors(TNFi), patients using TNF inhibitor (TNFi) |
| HydroxychloroquineAlso: HCQ200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response. | Drug | patients not using TNF inhibitors(TNFi), patients using TNF inhibitor (TNFi) |
| CertolizumabPegol injectionAlso: Cimzia200mg, iH,q2w, once two weeks (q2w) prescribed from the beginning and adjusted due to patient response. | Drug | patients using TNF inhibitor (TNFi) |
Primary outcome
The percentage of patients who achieve clinical remission using DAS28-CRP
Time frame: through study completion, an average of 10 months
The percentage of patients whose DAS28 achieve remission（DAS28-CRP≤ 2.6）and Low Disease Activity (DAS28-CRP ≤3.2) .
25 secondary outcomes
Early fetal loss
Time frame: within 10 weeks of gestation
Late fetal loss
Time frame: after 10 weeks of gestation
Still birth
Time frame: after 10 weeks of gestation
Preterm delivery
Time frame: between 28 and 37 weeks of gestation
Low-weight birth
Time frame: after 28 weeks of gestation
Premature rupture of membranes
Time frame: after 28 weeks of gestation
Placental abruption
Time frame: after 28 weeks of gestation
Fetal growth retardation (FGR)
Time frame: after 12 weeks of gestation
Number of participants with low amniotic fluid during pregnancy
Time frame: after 12 weeks of gestation
Number of participants with abnormal S / D values during pregnancy
Time frame: after 12 weeks of gestation
Number of participants with placental hematoma during pregnancy
Time frame: during pregnancy
Eclampsia
Time frame: after 20 weeks of gestation
Gestational diabetes
Time frame: through study completion, an average of 10 months
Gestational hypertension
Time frame: through study completion, an average of 10 months
Number of participants with placental infarction
Time frame: at delivery
Change From Baseline in C-reactive Protein (CRP)
Time frame: through study completion, an average of 10 months
Erythrocyte Sedimentation Rate (ESR)
Time frame: through study completion, an average of 10 months
Live birth rate
Time frame: After 28 weeks of gestation
Change from baseline Simplified Disease Activity Index (SDAI)
Time frame: through study completion, an average of 10 months
Change from baseline Clinical Disease Activity Index (CDAI)
Time frame: through study completion, an average of 10 months
swollen joint number (SW28)
Time frame: through study completion, an average of 10 months
tenderness joint number (T28)
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
Time frame: through study completion, an average of 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoyun Yang study director
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Pregnancy Related, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qiang Shu (0086-0531-82169654, shuqiang@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients who achieve clinical remission using DAS28-CRP (time frame: through study completion, an average of 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2022.