A Postmarketing, Multicenter, Longitudinal, Prospective, Pharmacokinetic, Phase 1b Study in Pregnant Women with Chroinc Inflammatory Diseases Treated with Cimzia (Certolizumab Pegol)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 5

Inclusion Criteria

1. Participant must be >=18 years of age at the time of signing the ICF.
2. Participant must be considered reliable and capable of adhering to the
protocol and visit schedule according to the judgment of the
investigator.
3. Participant is pregnant and <=10 weeks gestation at the time of
enrollment.
4. Participant must have been on stable, maintenance dose 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.
5. Participant expects to continue CZP therapy throughout pregnancy
and for at least 12 weeks postpartum.
6. 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 TB may enroll without having a TB test
performed.
7. Participants who are female.

Exclusion Criteria

1. Participant has any medical or psychiatric condition that, in the
opinion of the investigator, could jeopardize or would compromise the
study participant's ability to participate in this study.
2. Participant has a recent history of alcohol or drug abuse in the
investigator's medical judgment.
3. Participant has any evidence or medical history of an obstetrical or
psychiatric condition, or she or her fetus has any medical condition or
history (eg, primary or secondary antiphospholipid syndrome or
hypercoagulable state) that, in the opinion of the investigator, could
jeopardize or would compromise the study participant's ability to
participate in this study or the outcome of the pregnancy.
4. Participant has any evidence of clinically significant anemia in the
opinion of the investigator.
5. Participant has had significant documented morbidity during the past
12 weeks.
6. 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
-Current nontuberculous mycobacterial (NTM) infection or history of
NTM infection (unless proven to be fully recovered)
7. Significant allergies to humanized monoclonal antibodies.
8. Clinically significant multiple or severe drug allergies, or severe
posttreatment hypersensitivity reactions (including, but not limited to,
erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal
necrolysis, and exfoliative dermatitis).
9. Current or chronic history of clinically significant liver disease, or known
hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or
asymptomatic gallstones).
10. Study participant is taking a prohibited medication or has taken a
prohibited medication as defined in Section 6.5.2.
11. Live vaccine(s) within 1 month prior to Screening, or plans to receive such
vaccines during the study.

12. Participant has been dosed with an investigational medicinal product (IMP),
blinded IMP, or has received an investigational medical device or procedure
within the previous 120 daysor 5 half-lives (whichever is longer) prior to
Screening or is currently participating in another study of an IMP, blinded
IMP, or will receive an investigational medical device or procedure (excluding
noninterventional or registry studies).
13. Study participant has any clinically significant pregnancy-related clinical
or test abnormality, as judged by the investigator.
14. Study participant had a positive or indeterminate IGRA or TST test at
Screening. In case of indeterminate result, a retest is allowed if time
permits; 2 results of indeterminate require exclusion of the study participant.
15. Study participant has a history of human immunodeficiency virus, Hepatitis
B surface antigen (HBsAg), or Hepatitis C antibody prior to starting the
study.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Predose and postdose plasma CZP concentrations in women during pregnancy,<br /><br>relative to postpartum </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Plasma levels of anti-CZP antibodies throughout the study period<br /><br>Adverse events from time of informed consent through SFU<br /><br>Pregnancy outcome<br /><br>BMI<br /><br>CRP levels<br /><br>Albumin levels </p><br>