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
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis Pregnancy Related||Drug: Certolizumab Pegol 200 MG/ML [Cimzia] Drug: Hydroxychloroquine Drug: Prednisone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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.|
|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|
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.
400mg HCQ orally daily
10mg GC orally daily
- 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.
- ACR20 [ Time Frame: 52 week ]Proportion of ACR20 improvement.
- ACR50 [ Time Frame: 52 week ]Proportion of ACR50 improvement.
- ACR70 [ Time Frame: 52 week ]Proportion of ACR70 improvement.
- Time to remission [ Time Frame: 52 week ]
- 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.
- 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.
- Time to pregnancy [ Time Frame: 52 week ]
- Pregnancy rate [ Time Frame: 52 week ]
- Pregnancy outcomes [ Time Frame: 0-52 week ]Pregnancy will end with live birth, stillbirth, spontaneous abortion or therapeutic abortion.
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
|Contact: Le Zhangemail@example.com|
|Shanghai, Shanghai, China, 200001|
|Study Chair:||Liangjing Lu, doctor||RenJi Hospital|