Official Title
Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
Brief Summary

The objective of this program is to allow treating physicians to supply/continue to supply Certolizumab Pegol (CIMZIA®, CZP) to adults suffering from Crohn's Disease (CD), and who are considered not suitable for treatment, intolerant, have medical contraindications or had insufficient response with an authorized conventional therapy, including other authorized biologics.

Available
Individual Patients
Crohn's Disease

Drug: Certolizumab Pegol

Other Name: Cimzia

Eligibility Criteria

Inclusion Criteria:

- Patient comes from ending open label studies such as WELCOME -C87046, COSPAR - C87065,
MUSIC - C87043, PRECISE 3 - C87033, PRECISE 4 - C87034 and C87088

Exclusion Criteria:

- Patient has been treated with any experimental biological or non biological therapy
other than Certolizumab Pegol (CZP) within 5 plasma half-lifes*

- Has been treated with an approved biological, namely infliximab within the last 8
weeks, and adalimumab within the last 2 weeks*

- Known hypersensitivity to CZP or any of its excipients

- Current or recent history of severe, progressive, uncontrolled renal, hepatic,
haematological, gastrointestinal (other than Crohn's disease), endocrine, pulmonary,
cardiac, neurological, or cerebral disease

- Serious or life threatening infection within the last 6 months, any signs of current
or recent infection

- Active or latent tuberculosis (TB): if one or more of the 3 criteria is positive for
evidence of TB infection*:

1. A medical history of or a recent (< 6 months) active tuberculosis (TB)

2. A recent (<6 months) chest X-ray with signs consistent with TB infection

3. A recent (<6 months) positive purified protein derivative (PPD) skin test
(defined as induration or 5mm or more) and/or an indeterminate or positive
QuantiFERON-TB Gold or Elispot test.

It is recommended that patients are monitored at least annually for active and latent TB by
both 1) a chest X-ray read by a pulmonologist or radiologist and 2) a PPD skin test and/or
Elispot/ QuantiFERON TB Gold test

- Patient received live vaccinations including, but not limited to, oral polio, herpes
zoster, measles-mumps-rubella (MMR) or nasal influenza within the last 8 weeks or has
planned live immunizations during the planned period of administration of CZP

- Known prior or concurrent viral hepatitis B and C

- Known Human Immunodeficiency Virus (HIV) infection

- Concurrent malignancy or a history of malignant disease

- History of a lymphoproliferative disorder or any signs or symptoms suggestive of this
disease

- History of, or suspected or confirmed active demyelinating disease of the central
nervous system

- History of or concurrent New York Heart Association (NYHA) Class III/IV heart failure

- As the safety and efficacy of CZP has not been established in patients younger than 18
years of age, drug is not recommended for use in these patients until further data are
available

- As no data are available in pregnant women, drug should not be administered to female
patients of childbearing potential - unless an adequate method of contraception is
used - or to pregnant/lactating female patients.*

'*' Not applicable (NA) for patients on treatment with CZP from trials such as WELCOME
-C87046, COSPAR -C87065, MUSIC - C87043, PRECISE 3 - C87033, PRECISE 4 - C87034 and C87088.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Contacts

UCB Cares
+1 844 599 - 2273
UCBCares@ucb.com

UCB Cares, Study Director
001 844 599 2273 (UCB)

UCB Biopharma SRL
NCT Number
MeSH Terms
Crohn Disease
Certolizumab Pegol