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

Status: Unknown
Location: See location...
Intervention Type: Drug
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 45
Healthy Volunteers: f
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⁃ \- 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.

Locations
Other Locations
China
Qilu Hospital
RECRUITING
Jinan
Contact Information
Primary
Qiang Shu
shuqiang@sdu.edu.cn
0086-0531-82169654
Backup
Bingbing Ren
sdrenbingbing@163.com
+8618765361979
Time Frame
Start Date: 2021-07-30
Completion Date: 2024-12-31
Participants
Target number of participants: 100
Treatments
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Qilu Hospital of Shandong University

This content was sourced from clinicaltrials.gov