Pregnancy Related, Rheumatoid Arthritis
Conditions
Keywords
Certolizumab, Hydroxychloroquine
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.
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.
Interventions
DRUGCertolizumab Pegol 200 MG/ML [Cimzia]
CZP 200mg twice a week subcutaneous.
DRUGHydroxychloroquine
400mg HCQ orally daily
DRUGPrednisone
10mg GC orally daily
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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.
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.
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity | 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
| Measure | Time frame | Description |
|---|---|---|
| ACR50 | 52 week | Proportion of ACR50 improvement. |
| ACR70 | 52 week | Proportion of ACR70 improvement. |
| Time to remission | 52 week | — |
| MHAQ | 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. |
| ACR20 | 52 week | Proportion of ACR20 improvement. |
| Time to pregnancy | 52 week | — |
| Pregnancy rate | 52 week | — |
| Pregnancy outcomes | 0-52 week | Pregnancy will end with live birth, stillbirth, spontaneous abortion or therapeutic abortion. |
| EQ-5D | 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. |
Countries
China
Contacts
Primary ContactLe Zhang
Outcome results
None listed