Phase 1
Completed N=22
A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
Rheumatoid Arthritis · Psoriatic Arthritis · Crohn's Disease · Axial Spondyloarthritis
Source: ClinicalTrials.gov NCT04163016 ↗
Enrolled (actual)
22
Serious AEs
25.0%
Results posted
Sep 2024
Primary outcomePrimary: Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum — 15.251; NA; 16.916; 9.027 microgram per milliliter (μg/mL)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Predose and Postdose Plasma Certolizumab Pegol (CZP) Concentrations in Women During Pregnancy, Relative to Postpartum |
15.251; NA; 16.916; 9.027; 16.827; 2.759 | — |
| SECONDARY Number of Participants With Anti-certolizumab Pegol (CZP) Positive Antibodies Throughout the Study Period |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY Percentage of Participants With Adverse Events From Time of Informed Consent (Screening) Through Safety Follow-up (SFU) |
86.7; 60.0 | — |
| SECONDARY Number of Participants With Pregnancy Outcome |
12; 4; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04163016). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.