Axial Spondyloarthritis (AxSpA)Phase 1CRADLENCT02154425
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
A Phase 1 study testing Breast milk sampling and Certolizumab Pegol in people with Axial Spondyloarthritis (AxSpA) and Non-radiographic Evidence-AxSpA, run by UCB BIOSCIENCES, Inc. at 6 sites in 3 countries.
Trial summary
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose of maternal CZP. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis
- What is being tested?
- Breast milk sampling and Certolizumab Pegol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Sep 2014to Jan 2016
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- An IRB/IEC approved written Informed Consent form for participation of the maternal subject and her infant (for collection of infant demographic and AE data) is signed and dated by the subject. Where applicable, the written Informed Consent form with respect to the infant is also signed and dated by the holder of parental rights as designated by the maternal subject
- Subject is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator
- Subject is female and at least 18 years of age at the time of providing consent
- Subject has delivered term infant(s) (at least 37 weeks gestation)
- Subject is being treated with Certolizumab Pegol (CZP) per the current approved prescribing information
- The decision to treat with CZP or to breastfeed is made independently from and prior to the subject consenting to participate in this study
Show all 9Show fewer
- Subject agrees to use only the emollient or nipple cream provided by the Sponsor for use during the Sampling Period as described per protocol
- Subject is at least 6 weeks postpartum
- Subject is on an established dosing regimen of CZP (at least the third dose of CZP since starting/restarting CZP)
Who cannot join
- Subject is pregnant or plans to become pregnant during the study
- Subject is taking a prohibited medication or has taken a prohibited medication Note: any subjects requiring antibiotics must be discussed with the Medical Monitor prior to enrollment
- Subject has history of chronic alcohol abuse or drug abuse in the last year
- In subjects who intend to breastfeed, the infant has any abnormality noted on physical examination that, in the opinion of the Investigator, may jeopardize or compromise the subject's ability to participate in this study
- Subject has any medical, obstetrical or psychiatric condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study or the outcome of the pregnancy (as applicable). Note: subjects with mastitis infection should not have samples collected until the infection is completely resolved
- Subject has history of breast implants, breast augmentation, or breast reduction surgery
Show all 11Show fewer
- Subject has previously participated in this study
- Subject has participated in a study of an investigational medicinal product (IMP) (or a medical device) within the previous 30 days or 5 half-lives (whichever is longer) prior to Screening or is currently participating in another study of an IMP (or a medical device) unless the study is UCB UP0017 [NCT02019602] or a registry study
- Subject has received treatment with any biological therapeutic agent, or other anti-TNF agents with the exception of CZP, within 5 half-lives prior to obtaining the first sample
- Subject has a positive or indeterminate QuantiFERON®-TB GOLD In Tube test at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the subject
- Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent TB (LTB) infection. If tested within the 6 months prior to screening and test was negative for TB, and there is no change in the patient's clinical status, nor social, family, or travel history, there is no need for an additional TB testing at screening
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
United States3 sites
1
Chapel Hill, North Carolina
3
Durham, North Carolina
7
Los Angeles, California
About this study
Official title: A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose of maternal CZP.
Read the detailed description
The study will only include women who are receiving treatment with Certolizumab Pegol (CZP) for an approved indication in accordance with their treating physician, although this study is non-interventional regarding treatment with CZP, it is considered interventional due to the collection of breast milk from the lactating mothers.
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease, Psoriatic Arthritis, Rheumatoid Arthritis
- Being tested
- Breast milk sampling, Certolizumab Pegol
- Keywords
- Cimzia®, CZP, Breastfeeding, Nursing, Autoimmune diseases and pregnancy
- Medical subject headings
- Axial Spondyloarthritis, Spondylitis, Ankylosing, Crohn Disease, Arthritis, Psoriatic, Arthritis, Rheumatoid, Breast Feeding, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast milk samplingProcedure or surgery
Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of CZP on Day 0 of the Sampling Period, just prior to next scheduled dose of CZP, and on Days 2, 4, 6, 8, 10, 12, and 14 (pre-dose for mothers on CZP Q2W), relative to CZP administration on Day 0. In addition, in mothers on a CZP Q4W dosing regimen, the concentration of CZP in breast milk will also be evaluated on or about Day 28 (i.e., prior to and on the same day of the next scheduled administration of CZP).
Certolizumab PegolBiological
Also called Cimzia®
Mothers who decided to continue on, or to start treatment with, Certolizumab Pegol (CZP) for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetic samples | Experimental | Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of CZP on Day 0 of the Sampling Period, just prior to next scheduled dose of CZP, and on Days 2, 4, 6, 8, 10, 12, and 14 (pre-dose if Q2W dosing), relative to CZP administration on Day 0. In addition, in mothers on a CZP Q4W dosing regimen, the concentration of CZP in breast milk will also be evaluated on or about Day 28 (i.e., prior to and on the same day of the next scheduled administration of CZP).
Included are mothers who decided to continue on, or to start treatment with, Certolizumab Pegol (CZP) for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label. Receives: Procedure: Breast milk sampling; Biological: Certolizumab Pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0
Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.
Measured: Day 0
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2
Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.
Measured: Day 2
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4
Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.
Measured: Day 4
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6
Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.
Measured: Day 6
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8
Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.
Measured: Day 8
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10
Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.
Measured: Day 10
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12
Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.
Measured: Day 12
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14
Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.
Measured: Day 14
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28
In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.
Measured: Day 28
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2
Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.
Measured: Day 2
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4
Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.
Measured: Day 4
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6
Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.
Measured: Day 6
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8
Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.
Measured: Day 8
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10
Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.
Measured: Day 10
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12
Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.
Measured: Day 12
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14
Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.
Measured: Day 14
The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28
In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.
Measured: Day 28
The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)
Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.
Measured: From Day 0 to Day 14 or 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startSep 2014
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial Spondyloarthritis (AxSpA)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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB BIOSCIENCES, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Parexel
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154425
- Sponsor's protocol ID
- UP0016
- Other IDs
- 2013-004126-28
- Acronym
- CRADLE
- Status last verified
- Mar 2018
- First submitted
- 30 May 2014
- Last updated
- 3 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Clowse ME, Forger F, Hwang C, Thorp J, Dolhain RJ, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Toublanc N, Wang M, Hale TW. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017 Nov;76(11):1890-1896. doi: 10.1136/annrheumdis-2017-211384. Epub 2017 Aug 16.
PubMed 28814432
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)
- ClinicalTrials.gov ID
- NCT02154425
- Acronym / sponsor ID
- CRADLE / UP0016
- Conditions
- Axial Spondyloarthritis (AxSpA), Non-radiographic Evidence-AxSpA, Ankylosing Spondylitis, Crohn's Disease, Psoriatic Arthritis, Rheumatoid Arthritis
- Keywords
- Cimzia®, CZP, Breastfeeding, Nursing, Autoimmune diseases and pregnancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- UCB BIOSCIENCES, Inc.Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP, Parexel
- Study start
- Sep 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 6 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose of maternal CZP.
Detailed description
The study will only include women who are receiving treatment with Certolizumab Pegol (CZP) for an approved indication in accordance with their treating physician, although this study is non-interventional regarding treatment with CZP, it is considered interventional due to the collection of breast milk from the lactating mothers.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetic samples | Experimental | Procedure: Breast milk sampling, Biological: Certolizumab PegolPharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of CZP on Day 0 of the Sampling Period, just prior to next scheduled dose of CZP, and on Days 2, 4, 6, 8, 10, 12, and 14 (pre-dose if Q2W dosing), relative to CZP administration on Day 0. In addition, in mothers on a CZP Q4W dosing regimen, the concentration of CZP in breast milk will also be evaluated on or about Day 28 (i.e., prior to and on the same day of the next scheduled administration of CZP). Included are mothers who decided to continue on, or to start treatment with, Certolizumab Pegol (CZP) for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- An IRB/IEC approved written Informed Consent form for participation of the maternal subject and her infant (for collection of infant demographic and AE data) is signed and dated by the subject. Where applicable, the written Informed Consent form with respect to the infant is also signed and dated by the holder of parental rights as designated by the maternal subject
- Subject is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator
- Subject is female and at least 18 years of age at the time of providing consent
- Subject has delivered term infant(s) (at least 37 weeks gestation)
- Subject is being treated with Certolizumab Pegol (CZP) per the current approved prescribing information
Key exclusion criteria (11 listed)
- Subject is pregnant or plans to become pregnant during the study
- Subject is taking a prohibited medication or has taken a prohibited medication Note: any subjects requiring antibiotics must be discussed with the Medical Monitor prior to enrollment
- Subject has history of chronic alcohol abuse or drug abuse in the last year
- In subjects who intend to breastfeed, the infant has any abnormality noted on physical examination that, in the opinion of the Investigator, may jeopardize or compromise the subject's ability to participate in this study
- Subject has any medical, obstetrical or psychiatric condition that, in the opinion of the Investigator, can jeopardize or would compromise the subject's ability to participate in this study or the outcome of the pregnancy (as applicable). Note: subjects with mastitis infection should not have samples collected until the infection is completely resolved
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 |
|---|---|---|
| Breast milk samplingPharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of CZP on Day 0 of the Sampling Period, just prior to next scheduled dose of CZP, and on Days 2, 4, 6, 8, 10, 12, and 14 (pre-dose for mothers on CZP Q2W), relative to CZP administration on Day 0. In addition, in mothers on a CZP Q4W dosing regimen, the concentration of CZP in breast milk will also be evaluated on or about Day 28 (i.e., prior to and on the same day of the next scheduled administration of CZP). | Procedure or surgery | Pharmacokinetic samples |
| Certolizumab PegolAlso: Cimzia®Mothers who decided to continue on, or to start treatment with, Certolizumab Pegol (CZP) for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label. | Biological | Pharmacokinetic samples |
Primary outcome
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0
Time frame: Day 0
Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 2
Time frame: Day 2
Mature breast milk samples were collected on Day 2 of the Sampling Period for all subjects.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 4
Time frame: Day 4
Mature breast milk samples were collected on Day 4 of the Sampling Period for all subjects.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 6
Time frame: Day 6
Mature breast milk samples were collected on Day 6 of the Sampling Period for all subjects.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 8
Time frame: Day 8
Mature breast milk samples were collected on Day 8 of the Sampling Period for all subjects.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 10
Time frame: Day 10
Mature breast milk samples were collected on Day 10 of the Sampling Period for all subjects.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 12
Time frame: Day 12
Mature breast milk samples were collected on Day 12 of the Sampling Period for all subjects.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 14
Time frame: Day 14
Mature breast milk samples were collected (predose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 28
Time frame: Day 28
In subjects receiving CZP 400 mg Q4W, a mature breast milk sample were collected on or about Day 28, prior to the next scheduled administration of CZP.
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 2
Time frame: Day 2
Mature breast milk samples was collected on Day 2 of the Sampling Period for all subjects.
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 4
Time frame: Day 4
Mature breast milk samples was collected on Day 4 of the Sampling Period for all subjects.
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 6
Time frame: Day 6
Mature breast milk samples was collected on Day 6 of the Sampling Period for all subjects.
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 8
Time frame: Day 8
Mature breast milk samples was collected on Day 8 of the Sampling Period for all subjects.
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 10
Time frame: Day 10
Mature breast milk samples was collected on Day 10 of the Sampling Period for all subjects.
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 12
Time frame: Day 12
Mature breast milk samples was collected on Day 12 of the Sampling Period for all subjects.
The Calculated Daily Infant Dose of Certolizumab Pegol (CZP) in Breast on Day 14
Time frame: Day 14
Mature breast milk samples was collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 of the Sampling Period for all subjects.
The Calculated Infant Daily Dose of Certolizumab Pegol (CZP) in Breast Milk on Day 28
Time frame: Day 28
In subjects receiving CZP 400 mg Q4W, a mature breast milk sample was collected on or about Day 28, prior to the next scheduled administration of CZP.
The Average Daily Infant Dose of Certolizumab Pegol (CZP) Over the Dosing Interval (14 or 28 Days)
Time frame: From Day 0 to Day 14 or 28
Mature breast milk samples will be collected (pre-dose, as applicable for subjects receiving CZP 200 mg Q2W) on Day 14 or on Day 28 of the Sampling Period for all subjects.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28814432Clowse ME, Forger F, Hwang C, Thorp J, Dolhain RJ, van Tubergen A, Shaughnessy L, Simpson J, Teil M, Toublanc N, Wang M, Hale TW. Minimal to no transfer of certolizumab pegol into breast milk: results from CRADLE, a prospective, postmarketing, multicentre, pharmacokinetic study. Ann Rheum Dis. 2017 Nov;76(11):1890-1896. doi: 10.1136/annrheumdis-2017-211384. Epub 2017 Aug 16.
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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
+1 877 822 9493 (UCB)
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Breast milk sampling and Certolizumab Pegol in people with Axial Spondyloarthritis (AxSpA) and Non-radiographic Evidence-AxSpA, run by UCB BIOSCIENCES, Inc. at 6 sites in 3 countries.
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 9 inclusion and 11 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: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Netherlands, Switzerland. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Concentration of Certolizumab Pegol (CZP) in Breast Milk on Day 0 (time frame: Day 0). The study lists 18 primary outcomes in all. 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 NCT02154425, which also lists 1 linked publication.
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 3 Apr 2018.