Rheumatoid ArthritisNCT04569890
Treatment of Pregnancy RA
A study testing Certolizumab Pegol 200 MG/ML [Cimzia], Hydroxychloroquine and Prednisone in people with Rheumatoid Arthritis and Pregnancy Related, run by RenJi Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Rheumatoid Arthritis, Pregnancy Related
- What is being tested?
- Certolizumab Pegol 200 MG/ML [Cimzia], Hydroxychloroquine and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 1 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- A diagnosis of RA, as defined by 2010 ACR/EULAR criteria
- DAS 28∙ESR<2.6 under the treatment of DMARDs
- Subjects consider pregnancy, but not pregnant yet
- Participant expects to continue CZP therapy throughout pregnancy and for at least 24 weeks postpartum
- 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
Who cannot join
- 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
- 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)
- Study participant is taking a prohibited medication or has taken a prohibited medication
- Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study
- Study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Pregnancy Related
- Being tested
- Certolizumab Pegol 200 MG/ML [Cimzia], Hydroxychloroquine, Prednisone
- Keywords
- Certolizumab, Hydroxychloroquine
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab Pegol 200 MG/ML [Cimzia]Drug
CZP 200mg twice a week subcutaneous.
400mg HCQ orally daily
PrednisoneDrug
10mg GC orally daily
| Study group | Role | What they receive |
|---|---|---|
| CZP | Experimental | Certolizumab pegol: subcutaneous CZP at 200mg twice a week. Receives: Drug: Certolizumab Pegol 200 MG/ML [Cimzia] |
| GC+HCQ | Active comparator | 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. Receives: Drug: Hydroxychloroquine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity
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.
Measured: 24 week
Secondary outcomes (9)
ACR20
Proportion of ACR20 improvement.
Measured: 52 week
ACR50
Proportion of ACR50 improvement.
Measured: 52 week
ACR70
Proportion of ACR70 improvement.
Measured: 52 week
Time to remission
Measured: 52 week
MHAQ
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.
Measured: 52 week
EQ-5D
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.
Measured: 52 week
Time to pregnancy
Measured: 52 week
Pregnancy rate
Measured: 52 week
Pregnancy outcomes
Pregnancy will end with live birth, stillbirth, spontaneous abortion or therapeutic abortion.
Measured: 0-52 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liangjing Lu, doctor, Study chair, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569890
- Sponsor's protocol ID
- treatment of pregnancy RA
- Status last verified
- Sep 2020
- First submitted
- 20 Sep 2020
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Email the researchers for details.
Publications
Mariette X, Forger F, Abraham B, Flynn AD, Molto A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196. Epub 2017 Oct 13.
PubMed 29030361Forger F, Zbinden A, Villiger PM. Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients. Joint Bone Spine. 2016 May;83(3):341-3. doi: 10.1016/j.jbspin.2015.07.004. Epub 2015 Nov 23.
PubMed 26617214Clowse MEB, Scheuerle AE, Chambers C, Afzali A, Kimball AB, Cush JJ, Cooney M, Shaughnessy L, Vanderkelen M, Forger F. Pregnancy Outcomes After Exposure to Certolizumab Pegol: Updated Results From a Pharmacovigilance Safety Database. Arthritis Rheumatol. 2018 Sep;70(9):1399-1407. doi: 10.1002/art.40508. Epub 2018 Jul 22.
PubMed 29623679
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Treatment Strategy of Patients With Rheumatoid Arthritis During Pregnancy, a Randomized Control Trial in China
- ClinicalTrials.gov ID
- NCT04569890
- Acronym / sponsor ID
- treatment of pregnancy RA
- Conditions
- Rheumatoid Arthritis, Pregnancy Related
- Keywords
- Certolizumab, Hydroxychloroquine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| CZP | Experimental | Drug: Certolizumab Pegol 200 MG/ML [Cimzia]Certolizumab pegol: subcutaneous CZP at 200mg twice a week. |
| GC+HCQ | Active comparator | Drug: Hydroxychloroquine, Drug: PrednisoneHydroxychloroquine: 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A diagnosis of RA, as defined by 2010 ACR/EULAR criteria
- DAS 28∙ESR<2.6 under the treatment of DMARDs
- Subjects consider pregnancy, but not pregnant yet
- Participant expects to continue CZP therapy throughout pregnancy and for at least 24 weeks postpartum
- 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
Key exclusion criteria (6 listed)
- 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
- 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)
- Study participant is taking a prohibited medication or has taken a prohibited medication
- Live vaccine(s) within 1 month prior to Screening, or plans to receive such vaccines during the study
- Study participant has any clinically significant pregnancy-related clinical or test abnormality, as judged by the investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab Pegol 200 MG/ML [Cimzia]CZP 200mg twice a week subcutaneous. | Drug | CZP |
| Hydroxychloroquine400mg HCQ orally daily | Drug | GC+HCQ |
| Prednisone10mg GC orally daily | Drug | GC+HCQ |
Primary outcome
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.
9 secondary outcomes
ACR20
Time frame: 52 week
ACR50
Time frame: 52 week
ACR70
Time frame: 52 week
Time to remission
Time frame: 52 week
MHAQ
Time frame: 52 week
EQ-5D
Time frame: 52 week
Time to pregnancy
Time frame: 52 week
Pregnancy rate
Time frame: 52 week
Pregnancy outcomes
Time frame: 0-52 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Results publication: PubMed 29030361Mariette X, Forger F, Abraham B, Flynn AD, Molto A, Flipo RM, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Helmer E, Wang M, Chakravarty EF. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018 Feb;77(2):228-233. doi: 10.1136/annrheumdis-2017-212196. Epub 2017 Oct 13.
- Results publication: PubMed 26617214Forger F, Zbinden A, Villiger PM. Certolizumab treatment during late pregnancy in patients with rheumatic diseases: Low drug levels in cord blood but possible risk for maternal infections. A case series of 13 patients. Joint Bone Spine. 2016 May;83(3):341-3. doi: 10.1016/j.jbspin.2015.07.004. Epub 2015 Nov 23.
- Results publication: PubMed 29623679Clowse MEB, Scheuerle AE, Chambers C, Afzali A, Kimball AB, Cush JJ, Cooney M, Shaughnessy L, Vanderkelen M, Forger F. Pregnancy Outcomes After Exposure to Certolizumab Pegol: Updated Results From a Pharmacovigilance Safety Database. Arthritis Rheumatol. 2018 Sep;70(9):1399-1407. doi: 10.1002/art.40508. Epub 2018 Jul 22.
- Individual participant dataSharing planned: Undecided. Email the researchers for details.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liangjing Lu, doctor study chair
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Certolizumab Pegol 200 MG/ML [Cimzia], Hydroxychloroquine and Prednisone in people with Rheumatoid Arthritis and Pregnancy Related, run by RenJi Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Le Zhang (+8615618296046, joyce66dbl@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Activity (time frame: 24 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04569890, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2020.