Treatment of Pregnancy RA

Rheumatoid Arthritis Clinical Trial

Official title:

Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04569890
• Other study ID #: treatment of pregnancy RA
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 1, 2023

Study information

• Verified date: September 2020
• Source: RenJi Hospital
• Contact: Le Zhang
• Phone: +8615618296046
• Email: joyce66dbl[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

It is important to control the disease of pregnant women with rheumatoid arthritis to ensure the fetal and maternal health. Frequent disease flare can increase the risk of adverse pregnancy outcomes, including abortion, premature delivery and low birth weight. However, there is no scientific and standardized treatment strategy for RA during pregnancy. About 50% of RA patients need treatment during pregnancy. Tumor necrosis inhibitor (TNFi) is an effective treatment, which can significantly improve the symptoms of RA during pregnancy. However, in order to avoid placental metastasis, TNFi is usually stopped in early pregnancy. Certolizumab pegol (CZP) is a PEGylated, Fc-free TNFi, which does not bind FcRn and is consequently not expected to undergo FcRn-mediated transfer across the placenta. Therefore, it can not transfer through placenta into FcRn and is approved to treat RA during pregnancy. This study focuses on patients with RA who consider pregnancy. We compared the efficacy, safety and economy of CZP and glucocorticoids combined with hydroxychloroquine by a randomized controlled trial.

Description:

In this study, a randomized controlled study was conducted to compare the efficacy, safety and economy of CZP and glucocorticoids combined with hydroxychloroquine in the treatment of RA patients who consider pregnancy. Informed consent must be obtained for the patients to be screened.

Random method: central random.

Blinding method: assessor and data analyst blindness.

Follow-up: every 4 week.

First endpoint: 24 week.

Second endpoint: 52 week.

Safety endpoint: 24 weeks postpartum.

Missing data: core data related to treatment and disease activity are not allowed to be missing, and other data are supplemented by the last observation value.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

1. A diagnosis of RA, as defined by 2010 ACR/EULAR criteria

2. DAS 28·ESR<2.6 under the treatment of DMARDs

3. Subjects consider pregnancy, but not pregnant yet

4. Participant expects to continue CZP therapy throughout pregnancy and for at least 24 weeks postpartum

5. Participant has a negative interferon gamma release assay (IGRA) or tuberculin skin test (TST) within the prior 6 months, and there has been no change in the study participant's clinical status, or social, family, or travel history. Participants with documented Bacillus Calmette-Guérin (BCG) vaccine and at low risk for tuberculosis (TB) may enroll without having a TB test performed

Exclusion Criteria:

1. Participant has any medical or psychiatric condition that, in the opinion of the investigator, could jeopardize or would compromise the study participant's ability to participate in this study

2. Participant is not permitted to enroll into the study if she meets any of the following TB exclusion criteria:(1) Known active TB disease; (2) History of active TB involving any organ system; (3) Latent TB infection; (4) High risk of acquiring TB infection; (5) Current nontuberculous mycobacterial (NTM) infection or history of NTM infection (unless proven to be fully recovered)

3. Study participant is taking a prohibited medication or has taken a prohibited medication

4. Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study

5. Study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator

6. Study participant had a positive or indeterminate interferon gamma release assay (IGRA) or tuberculin skin test (TST) at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the study participant

Related Conditions & MeSH terms

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

Intervention

Drug:
• Certolizumab Pegol 200 MG/ML [Cimzia]
CZP 200mg twice a week subcutaneous.
• Hydroxychloroquine
400mg HCQ orally daily
• Prednisone
10mg GC orally daily

Locations

Country	Name	City	State
China	Renji Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
RenJi Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Clowse MEB, Scheuerle AE, Chambers C, Afzali A, Kimball AB, Cush JJ, Cooney M, Shaughnessy L, Vanderkelen M, Förger F. Pregnancy Outcomes After Exposure to Certolizumab Pegol: Updated Results From a Pharmacovigilance Safety Database. Arthritis Rheumatol. — View Citation

Förger F, Zbinden A, Villiger PM. Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients. Joint Bone Spine. 2016 May;83(3):341 — View Citation

Mariette X, Förger F, Abraham B, Flynn AD, Moltó A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmark — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity	Proportion of DAS28 remission. In principle, the score of das28-esr should be used. If there is data missing, das28-crp can be used. All patients have either complete das28-esr data or complete das28-crp data.	24 week
Secondary	ACR20	Proportion of ACR20 improvement.	52 week
Secondary	ACR50	Proportion of ACR50 improvement.	52 week
Secondary	ACR70	Proportion of ACR70 improvement.	52 week
Secondary	Time to remission		52 week
Secondary	MHAQ	The Modified Health Assessment Questionnaire (MHAQ), reduced the number of items from 20 in the original HAQ to eight, and improved the feasibility in clinical practice when screening patients. The MHAQ score is calculated as the mean of the scores for each activity. Total score is between 0.0-3.0, in 0.125 increments. Higher scores indicate worse function and greater disability. MHAQ scores <0.3 are considered normal.	52 week
Secondary	EQ-5D	Health quality assessed by EuroQol five dimensions questionnaire. It is a preference-based measure that can be regarded as a continuous outcome scored on a -0.59 to 1.00 scale, with 1.00 indicating 'full health' and 0 representing dead.	52 week
Secondary	Time to pregnancy		52 week
Secondary	Pregnancy rate		52 week
Secondary	Pregnancy outcomes	Pregnancy will end with live birth, stillbirth, spontaneous abortion or therapeutic abortion.	0-52 week