Treatment of Pregnancy RA

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-12-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Pregnancy Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Central random. Statistical experts from a third-party company not involved in the study will generate a random number table by computer system. The patients will be numbered according to their visiting order, and 1:1 allocated according to the random data table.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Assessor and data analyst blindness. To avoid bias, physicians who assess disease activity will be blinded. Participants are required not to discuss their treatment allocation with physicians at each visit. The success of the blind method will be judged by requiring the assessors to determine the treatment allocation of participants after each visit. When the database is locked, the statistician will carry on the data analysis in the hidden of allocation.

Study Groups

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CZP

Certolizumab pegol: subcutaneous CZP at 200mg twice a week.

Group Type EXPERIMENTAL

Certolizumab Pegol 200 MG/ML [Cimzia]

Intervention Type DRUG

CZP 200mg twice a week subcutaneous.

GC+HCQ

Hydroxychloroquine: HCQ at 200mg daily, and if tolerated, escalated to 400 mg daily.

Glucocorticoid: continuous usage GC at 10mg a day from Week 0 to Week 52.

At 24 week, non-responders (ΔDAS28\<0.6) will switch to the other group. Participants switched to CZP group will taper their dose of GC gradually, if they have an improvement in disease activity (two successive DAS28\<2.6). If participants have a disease flare (increased DAS28\>0.6) during a reduction in corticosteroid dose, then they will resume their previous dose. Weekly step-down GC scheme: 10mg-7.5mg-5mg-2.5mg-0mg.

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type DRUG

400mg HCQ orally daily

Prednisone

Intervention Type DRUG

10mg GC orally daily

Interventions

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Certolizumab Pegol 200 MG/ML [Cimzia]

CZP 200mg twice a week subcutaneous.

Intervention Type DRUG

Hydroxychloroquine

400mg HCQ orally daily

Intervention Type DRUG

Prednisone

10mg GC orally daily

Intervention Type DRUG

Eligibility Criteria

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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
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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No