Rheumatoid Arthritis (RA)NCT02775656
UCB Cimzia Pregnancy Follow-up Study
An observational study of Rheumatoid Arthritis (RA) and Crohn's Disease (CD), run by UCB BIOSCIENCES, Inc. at 1 site in United States.
Trial summary
The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a Certolizumab Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Rheumatoid Arthritis (RA), Crohn's Disease (CD), Psoriatic Arthritis (PsA)
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2017
- Phase
- Observational
- 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 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Study population: The study population consists of women who become pregnant while enrolled in a Certolizumab Pegol (CZP) study, or whose pregnancies otherwise are reported to UCB due to potential CZP exposure during pregnancy, and any resulting offspring. All pregnancies reported while the patient is enrolled in the CZP study are eligible regardless of treatment arm in the CZP study (eg, commercial or investigational CZP, placebo, or comparator treatment), pregnancy outcome (eg, live birth,spontaneous abortion, induced abortion, stillbirth) or any treatment decisions following discontinuation from the clinical study or report of the pregnancy.
Who may be able to join
- Pregnancy is identified while the patient is participating in an interventional or noninterventional Certolizumab Pegol (CZP) study conducted by UCB, or a development partner, regardless of phase or treatment arm (ie, commercial or investigational, placebo or comparator treatment), or whose pregnancies were spontaneously reported to UCB due to potential CZP exposure during pregnancy
- Sufficient information to classify the pregnancy as prospective or retrospective is available
- Full initial reporter (ie, woman or healthcare provider (HCP)) contact information reported to allow for follow-up (name, address, telephone number/email address) and contact information for at least 1 applicable HCP if initial contact is the woman
- Consent to participate is provided
Who cannot join
- Pregnancies in which the resulting infant is over 1 year of age at the time of informed consent will not be eligible to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Follow-up Study of Women Who Become Pregnant While Participating in a Certolizumab Pegol (CZP) Clinical Study or Whose Pregnancies Have Otherwise Been Reported to UCB Due to Potential CZP Exposure During Pregnancy
The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a Certolizumab Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy.
- Conditions
- Rheumatoid Arthritis (RA), Crohn's Disease (CD), Psoriatic Arthritis (PsA), Axial Spondyloarthritis and Ankylosing Spondylitis
- Keywords
- Cimzia®, CZP, Pregnancy Follow up study, Autoimmune diseases, Pregnancy outcomes, major congenital malformations, birth outcomes, malformation, birth defect
- Medical subject headings
- Arthritis, Rheumatoid, Crohn Disease, Arthritis, Psoriatic, Axial Spondyloarthritis, Spondylitis, Ankylosing, Autoimmune Diseases, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective cohort | For a pregnancy to be enrolled in the prospective cohort, the pregnancy outcome cannot be known (ie, no prenatal diagnosis of a fetus with a congenital defect and the pregnancy is still ongoing at the time of consent). | |
| Retrospective cohort | For a pregnancy to be enrolled in the retrospective cohort, the pregnancy outcome must already be known (ie, a congenital defect has already been identified at the time of consent into the pregnancy follow-up study, or the pregnancy has been completed at the time of consent). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of newborns with major congenital malformations
The prevalence of major congenital malformations (MCMs) reported will be calculated by dividing the number of offspring with MCMs by the total number of live births and fetal losses with an MCM for all enrolled pregnancies and then stratified by treatment during pregnancy. The prevalence of MCMs will be calculated as soon as there are at least 50 prospectively-enrolled patients with an available outcome. Stillbirths and induced abortions (at 20 weeks gestation or greater) with reported MCMs are included in the estimate of the MCM prevalence.
Measured: At 20 weeks gestation or greater
Percentage of pregnancy outcomes with major congenital malformations
The pregnancy outcomes with and without MCMs will be summarized using frequency counts by all trimesters of exposure and earliest trimester of exposure.
Measured: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Secondary outcomes (36)
Numbers of maternal pregnancy-related events
Descriptive statistics will be presented for the numbers of maternal pregnancy-related adverse events (AEs), adverse birth. Frequencies and proportions of adverse pregnancy will be presented using descriptive statistics. Analyses may include (but are not limited to) stratification by trimester of exposure, gestational age at time of consent, maternal age, and geographic region.
Measured: During pregnancy up to Week 40
Percentage of Vaginal and C-section deliveries
Measured: At birth (Day 0)
Gestational age at birth
Measured: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Birth weight
Measured: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Small for gestation age
Measured: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Percentage of adverse events in infants
Percentage of adverse events (AEs) being collected in infants at study follow-up period (first 18 months)
Measured: Within the first 18 months of life
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Measured: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Measured: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)
Measured: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Measured: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Measured: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)
Measured: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Measured: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Measured: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Measured: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Measured: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Assessment of developmental milestones is carried out based on patient or physician report of development milestones met (Yes/No answer). 'Yes' indicates 'milestone met'; 'No' indicates 'milestone not met'.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startNov 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Parexel
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, UCB Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775656
- Sponsor's protocol ID
- UP0019
- Status last verified
- Apr 2021
- First submitted
- 8 Mar 2016
- Last updated
- 22 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Follow-up Study of Women Who Become Pregnant While Participating in a Certolizumab Pegol (CZP) Clinical Study or Whose Pregnancies Have Otherwise Been Reported to UCB Due to Potential CZP Exposure During Pregnancy
- ClinicalTrials.gov ID
- NCT02775656
- Acronym / sponsor ID
- UP0019
- Conditions
- Rheumatoid Arthritis (RA), Crohn's Disease (CD), Psoriatic Arthritis (PsA), Axial Spondyloarthritis and Ankylosing Spondylitis
- Keywords
- Cimzia®, CZP, Pregnancy Follow up study, Autoimmune diseases, Pregnancy outcomes, major congenital malformations, birth outcomes, malformation
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 1 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, Parexel
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 17 May 2016 (estimated)
- 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.
The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring of women who become pregnant while participating in a Certolizumab Pegol (CZP) study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective cohort | – | –For a pregnancy to be enrolled in the prospective cohort, the pregnancy outcome cannot be known (ie, no prenatal diagnosis of a fetus with a congenital defect and the pregnancy is still ongoing at the time of consent). |
| Retrospective cohort | – | –For a pregnancy to be enrolled in the retrospective cohort, the pregnancy outcome must already be known (ie, a congenital defect has already been identified at the time of consent into the pregnancy follow-up study, or the pregnancy has been completed at the time of consent). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study population consists of women who become pregnant while enrolled in a Certolizumab Pegol (CZP) study, or whose pregnancies otherwise are reported to UCB due to potential CZP exposure during pregnancy, and any resulting offspring. All pregnancies reported while the patient is enrolled in the CZP study are eligible regardless of treatment arm in the CZP study (eg, commercial or investigational CZP, placebo, or comparator treatment), pregnancy outcome (eg, live birth,spontaneous abortion, induced abortion, stillbirth) or any treatment decisions following discontinuation from the clinical study or report of the pregnancy.
Key inclusion criteria (4 listed)
- Pregnancy is identified while the patient is participating in an interventional or noninterventional Certolizumab Pegol (CZP) study conducted by UCB, or a development partner, regardless of phase or treatment arm (ie, commercial or investigational, placebo or comparator treatment), or whose pregnancies were spontaneously reported to UCB due to potential CZP exposure during pregnancy
- Sufficient information to classify the pregnancy as prospective or retrospective is available
- Full initial reporter (ie, woman or healthcare provider (HCP)) contact information reported to allow for follow-up (name, address, telephone number/email address) and contact information for at least 1 applicable HCP if initial contact is the woman
- Consent to participate is provided
Key exclusion criteria (1 listed)
- Pregnancies in which the resulting infant is over 1 year of age at the time of informed consent will not be eligible to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of newborns with major congenital malformations
Time frame: At 20 weeks gestation or greater
The prevalence of major congenital malformations (MCMs) reported will be calculated by dividing the number of offspring with MCMs by the total number of live births and fetal losses with an MCM for all enrolled pregnancies and then stratified by treatment during pregnancy. The prevalence of MCMs will be calculated as soon as there are at least 50 prospectively-enrolled patients with an available outcome. Stillbirths and induced abortions (at 20 weeks gestation or greater) with reported MCMs are included in the estimate of the MCM prevalence.
Percentage of pregnancy outcomes with major congenital malformations
Time frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
The pregnancy outcomes with and without MCMs will be summarized using frequency counts by all trimesters of exposure and earliest trimester of exposure.
36 secondary outcomes
Numbers of maternal pregnancy-related events
Time frame: During pregnancy up to Week 40
Percentage of Vaginal and C-section deliveries
Time frame: At birth (Day 0)
Gestational age at birth
Time frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Birth weight
Time frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Small for gestation age
Time frame: Estimated date of delivery (EDD) up to 6 weeks post-EDD
Percentage of adverse events in infants
Time frame: Within the first 18 months of life
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to head circumference (based on the relevant population norm for the infant)
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to weight (based on the relevant population norm for the infant)
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to height (based on the relevant population norm for the infant)
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to gross motor skills
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to fine motor skills
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to language
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to cognitive skills
Time frame: 18 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Time frame: At birth (Day 0)
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Time frame: 4 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Time frame: 12 months
Percentage of infants less than or equal to the 10th percentile for sex and age with respective to social skills
Time frame: 18 months
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2021.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
UCB Cares study director
UCB Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis (RA) and Crohn's Disease (CD), run by UCB BIOSCIENCES, Inc. at 1 site in United States.
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 4 inclusion and 1 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: stopped early, as of the sponsor's last update on 22 Apr 2021. 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 United States. 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?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of newborns with major congenital malformations (time frame: At 20 weeks gestation or greater). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2021.