Rheumatoid ArthritisPhase 1CHERISHNCT04163016
A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
A Phase 1 study testing Pharmacokinetics of certolizumab pegol in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by UCB Biopharma SRL at 9 sites in 6 countries.
Trial summary
The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease
- What is being tested?
- Pharmacokinetics of certolizumab pegol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 19 Jun 2020to 23 May 2023
- 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
- Participant is pregnant and ≤10 weeks gestation at the time of enrollment
- Participant must have been on stable, maintenance dose certolizumab pegol (CZP) treatment for at least 12 weeks independent of and prior to being enrolled in this study, for an approved indication in accordance with her treating physician
- Participant expects to continue CZP therapy throughout pregnancy and for at least 12 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:
- Known active TB disease
- History of active TB involving any organ system
- Latent TB infection
- High risk of acquiring TB infection
Show all 11Show fewer
- 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
9 sites in 6 countries.
9 sites in 6 countries
United States3 sites
Up0085 103
Durham, North Carolina, 27710
Up0085 104
Minneapolis, Minnesota, 55455
Up0085 101
Oklahoma City, Oklahoma, 73104
About this study
Official title: A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Axial Spondyloarthritis, Plaque Psoriasis
- Being tested
- Pharmacokinetics of certolizumab pegol
- Keywords
- Cimzia, Certolizumab Pegol, Pregnant Women, Crohn's Disease (CD), Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Plaque Psoriasis (PSO), Axial Spondyloarthritis (AxSpA), Pharmacokinetics, CZP
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis, Psoriatic, Crohn Disease, Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pharmacokinetics of certolizumab pegolDrug
Also called PK
The collection of blood samples for pharmacokinetics (PK) is considered interventional. Blood samples will be drawn at enrollment, predose every 4 weeks (Q4W), postdose every 8 weeks (Q8W) and postpartum predose and postdose.
Study participants will be responsible for obtaining and administering commercially available approved dosing regimens of certolizumab pegol (CZP) as prescribed by each study participant's own physician.
| Study group | Role | What they receive |
|---|---|---|
| Pharmacokinetics Sampling | Experimental | This study will include pregnant women who have decided to continue treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants will be responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label.
From all study participants blood samples will be drawn for pharmacokinetics during the study. Receives: Drug: Pharmacokinetics of certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum
Predose and postdose plasma CZP concentrations in women during pregnancy, relative to postpartum, were measured. The trimesters were defined as follows: Trimester 1=up to 12 weeks and 6 days gestation, trimester 2=13-28 weeks and 6 days gestation, and trimester 3=any time at or after 29 weeks gestation.
Measured: Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)
Secondary outcomes (3)
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period
Antibodies to CZP were evaluated in plasma samples collected from all participants throughout the study. Anti-CZP antibodies (ADAb) were measured using a three-tiered assay approach: screening, confirmatory and titration assay. Samples that were confirmed as positive in the screening and confirmatory assay were evaluated in a titration assay to quantify the ADAb level and were reported as titer (reciprocal dilution factor including minimum required dilution [MRD]). Sample values that were 'positive screen' and 'positive immunodepletion' were defined as ADAb positive. Once determined positive, a study participant's highest titer was used to categorize ("titer classification") the study participant as follows: Positive less than or equal to (=)32, Positive greater than (>)32 - =128, Positive >128 - =512, Positive >512 - =1024, Positive >1024 - =4096, and Positive >4096.
Measured: From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)
Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)
An adverse event (AE) was any untoward medical occurrence in a patient or clinical participant, temporally associated with the use of CZP, whether or not considered related to CZP.
Measured: From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)
Number of Participants With Pregnancy Outcome
Pregnancy outcomes were collected via a written notification by the investigator and recorded in the Pregnancy Outcome Form. Pregnancies were determined to end in delivery-live birth, delivery-still birth, spontaneous abortion, therapeutic abortion, or missing data.
Measured: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2019
- Study start19 Jun 2020
- Primary completion23 May 2023
- Study completion23 May 2023
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 Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04163016
- Sponsor's protocol ID
- UP0085
- Acronym
- CHERISH
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2019
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
Publications
Clowse MEB, Dolhain RJEM, Finzel S, Forger F, Glaser C, Pluma A, Shaughnessy L, Sidhu J, Greenin J, Rice K, Utturkar G, Duarte JN, Teil M. Pharmacokinetics of Certolizumab Pegol in Pregnancy: Results from the Open-Label CHERISH Study. Rheumatol Ther. 2026 Jun;13(3):813-828. doi: 10.1007/s40744-026-00853-2. Epub 2026 Apr 21.
PubMed 42012633
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
- ClinicalTrials.gov ID
- NCT04163016
- Acronym / sponsor ID
- CHERISH / UP0085
- Conditions
- Rheumatoid Arthritis, Psoriatic Arthritis, Crohn's Disease, Axial Spondyloarthritis, Plaque Psoriasis
- Keywords
- Cimzia, Certolizumab Pegol, Pregnant Women, Crohn's Disease (CD), Rheumatoid Arthritis (RA), Psoriatic Arthritis (PsA), Plaque Psoriasis (PSO), Axial Spondyloarthritis (AxSpA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2020 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 23 May 2023 (actual)
- First posted
- 14 Nov 2019 (actual)
- Results
- Posted 19 Sep 2024
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 the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pharmacokinetics Sampling | Experimental | Drug: Pharmacokinetics of certolizumab pegolThis study will include pregnant women who have decided to continue treatment with commercial certolizumab pegol (CZP) in accordance with their treating physician prior to participating in the study. Study participants will be responsible for obtaining and administering commercially available CZP under the care of their physician and according to the locally approved product label. From all study participants blood samples will be drawn for pharmacokinetics during the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant is pregnant and ≤10 weeks gestation at the time of enrollment
- Participant must have been on stable, maintenance dose certolizumab pegol (CZP) treatment for at least 12 weeks independent of and prior to being enrolled in this study, for an approved indication in accordance with her treating physician
- Participant expects to continue CZP therapy throughout pregnancy and for at least 12 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 (11 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:
- 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 |
|---|---|---|
| Pharmacokinetics of certolizumab pegolAlso: PKThe collection of blood samples for pharmacokinetics (PK) is considered interventional. Blood samples will be drawn at enrollment, predose every 4 weeks (Q4W), postdose every 8 weeks (Q8W) and postpartum predose and postdose. Study participants will be responsible for obtaining and administering commercially available approved dosing regimens of certolizumab pegol (CZP) as prescribed by each study participant's own physician. | Drug | Pharmacokinetics Sampling |
Primary outcome
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum
Time frame: Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)
Predose and postdose plasma CZP concentrations in women during pregnancy, relative to postpartum, were measured. The trimesters were defined as follows: Trimester 1=up to 12 weeks and 6 days gestation, trimester 2=13-28 weeks and 6 days gestation, and trimester 3=any time at or after 29 weeks gestation.
3 secondary outcomes
Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period
Time frame: From Enrollment to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)
Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU)
Time frame: From Screening to Safety Follow-up (Duration of pregnancy (up to 40 weeks) + 18 weeks) (up to 58 weeks)
Number of Participants With Pregnancy Outcome
Time frame: From Enrollment to Delivery (Duration of pregnancy, up to 40 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42012633Clowse MEB, Dolhain RJEM, Finzel S, Forger F, Glaser C, Pluma A, Shaughnessy L, Sidhu J, Greenin J, Rice K, Utturkar G, Duarte JN, Teil M. Pharmacokinetics of Certolizumab Pegol in Pregnancy: Results from the Open-Label CHERISH Study. Rheumatol Ther. 2026 Jun;13(3):813-828. doi: 10.1007/s40744-026-00853-2. Epub 2026 Apr 21.
- Individual participant dataSharing planned: No. Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.
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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
001 844 599 2273 (UCB)
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pharmacokinetics of certolizumab pegol in people with Rheumatoid Arthritis and Psoriatic Arthritis, run by UCB Biopharma SRL at 9 sites in 6 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 4 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Germany, France, Netherlands, Spain and 1 more country. 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 19 Sep 2024). 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?
Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum (time frame: Predose and postdose CZP concentrations in Pregnancy trimester 1,2,3 (up to 40 weeks) and Postpartum (up to 13 weeks after delivery)). 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 NCT04163016, 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 19 Sep 2024.