Trials / Completed
CompletedNCT02019602
A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta
A Multicenter Postmarketing Study to Evaluate the Placental Transfer of Certolizumab Pegol in Pregnant Women Receiving Treatment With Cimzia® (Certolizumab Pegol)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 37 (actual)
- Sponsor
- UCB BIOSCIENCES, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary purpose is to assess whether there is transfer of Certolizumab Pegol (CZP) from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.
Conditions
- Axial Spondyloarthritis (AxSpA)
- Non-radiographic Evidence-AxSpA
- Ankylosing Spondylitis
- Crohn's Disease
- Psoriatic Arthritis
- Rheumatoid Arthritis
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Blood sampling from mother | A blood sample from the mother will be taken within 24 hours before/after the delivery. |
| PROCEDURE | Blood sampling from infant | Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8. |
| PROCEDURE | Blood sampling from umbilical cord | A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery. |
| BIOLOGICAL | Certolizumab Pegol | Mothers who decided to continue on, or to start treatment with, 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. * Active Substance: Certolizumab Pegol * Pharmaceutical Form: Solution for injection * Concentration: 200 mg/ml * Route of Administration: Subcutaneous Use |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2016-10-01
- Completion
- 2016-11-01
- First posted
- 2013-12-24
- Last updated
- 2019-06-21
- Results posted
- 2019-06-21
Locations
8 sites across 4 countries: United States, France, Netherlands, Switzerland
Source: ClinicalTrials.gov record NCT02019602. Inclusion in this directory is not an endorsement.