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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT04569890
Date of registration: 20/09/2020
Prospective Registration: Yes
Primary sponsor: RenJi Hospital
Public title: Treatment of Pregnancy RA
Scientific title: Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China
Date of first enrolment: December 1, 2020
Target sample size: 100
Recruitment status: Not yet recruiting
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Name:     Le Zhang
Telephone: +8615618296046
Name:     Liangjing Lu, doctor
Affiliation:  RenJi Hospital
Key inclusion & exclusion 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

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

Age minimum: 20 Years
Age maximum: 40 Years
Gender: Female
Health Condition(s) or Problem(s) studied
Pregnancy Related
Rheumatoid Arthritis
Drug: Certolizumab Pegol 200 MG/ML [Cimzia]
Drug: Hydroxychloroquine
Drug: Prednisone
Primary Outcome(s)
Disease Activity [Time Frame: 24 week]
Secondary Outcome(s)
ACR20 [Time Frame: 52 week]
ACR50 [Time Frame: 52 week]
ACR70 [Time Frame: 52 week]
EQ-5D [Time Frame: 52 week]
MHAQ [Time Frame: 52 week]
Pregnancy outcomes [Time Frame: 0-52 week]
Pregnancy rate [Time Frame: 52 week]
Time to pregnancy [Time Frame: 52 week]
Time to remission [Time Frame: 52 week]
Secondary ID(s)
treatment of pregnancy RA
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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