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Treatment of Pregnancy RA

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ClinicalTrials.gov Identifier: NCT04569890
Recruitment Status : Not yet recruiting
First Posted : September 30, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
RenJi Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Pregnancy Related Drug: Certolizumab Pegol 200 MG/ML [Cimzia] Drug: Hydroxychloroquine Drug: Prednisone Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CZP
Certolizumab pegol: subcutaneous CZP at 200mg twice a week.
Drug: Certolizumab Pegol 200 MG/ML [Cimzia]
CZP 200mg twice a week subcutaneous.

Active Comparator: 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.

Drug: Hydroxychloroquine
400mg HCQ orally daily

Drug: Prednisone
10mg GC orally daily




Primary Outcome Measures :
  1. Disease Activity [ Time Frame: 24 week ]
    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.


Secondary Outcome Measures :
  1. ACR20 [ Time Frame: 52 week ]
    Proportion of ACR20 improvement.

  2. ACR50 [ Time Frame: 52 week ]
    Proportion of ACR50 improvement.

  3. ACR70 [ Time Frame: 52 week ]
    Proportion of ACR70 improvement.

  4. Time to remission [ Time Frame: 52 week ]
  5. MHAQ [ Time Frame: 52 week ]
    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.

  6. EQ-5D [ Time Frame: 52 week ]
    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.

  7. Time to pregnancy [ Time Frame: 52 week ]
  8. Pregnancy rate [ Time Frame: 52 week ]
  9. Pregnancy outcomes [ Time Frame: 0-52 week ]
    Pregnancy will end with live birth, stillbirth, spontaneous abortion or therapeutic abortion.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04569890


Contacts
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Contact: Le Zhang +8615618296046 joyce66dbl@hotmail.com

Locations
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China, Shanghai
Renji Hospital
Shanghai, Shanghai, China, 200001
Sponsors and Collaborators
RenJi Hospital
Investigators
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Study Chair: Liangjing Lu, doctor RenJi Hospital
Publications of Results:
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Responsible Party: RenJi Hospital
ClinicalTrials.gov Identifier: NCT04569890    
Other Study ID Numbers: treatment of pregnancy RA
First Posted: September 30, 2020    Key Record Dates
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Email the researchers for details.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by RenJi Hospital:
Certolizumab
Hydroxychloroquine
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Hydroxychloroquine
Prednisone
Certolizumab Pegol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors