Treatment of Pregnancy RA
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Pregnancy Related
- Rheumatoid Arthritis
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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
Participation Requirements
- Age
- Between 20 years and 40 years
- Gender
- Only males
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:...
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.
Tracking Information
- NCT #
- NCT04569890
- Collaborators
- Not Provided
- Investigators
- Study Chair: Liangjing Lu, doctor RenJi Hospital
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