A Multicener, Postmarketing Study Evaluating the Transfer of Cimzia From the Mother to the Infant Via the Placenta

PHASE1CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

January 31, 2014

Primary Completion Date

October 31, 2016

Study Completion Date

November 30, 2016

Conditions
Axial Spondyloarthritis (AxSpA)Non-radiographic Evidence-AxSpAAnkylosing SpondylitisCrohn's DiseasePsoriatic ArthritisRheumatoid Arthritis
Interventions
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"

Trial Locations (8)

Unknown

11, Scottsdale

9, Oklahoma City

101, Salt Lake City

203, Lille

200, Paris

202, Paris

500, Maastricht

20, Bern

Sponsors
All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

collaborator

Parexel

INDUSTRY

lead

UCB BIOSCIENCES, Inc.

INDUSTRY