Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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7 August 2023 |
Main ID: |
NCT03559660 |
Date of registration:
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05/06/2018 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
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Scientific title:
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Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD) |
Date of first enrolment:
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December 1, 2018 |
Target sample size:
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Recruitment status: |
Available |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03559660 |
Study type:
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Expanded Access |
Study design:
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Phase:
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Contacts
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Name:
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UCB Cares |
Address:
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Telephone:
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+1 844 599 |
Email:
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UCBCares@ucb.com |
Affiliation:
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Name:
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UCB Cares |
Address:
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Telephone:
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Email:
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Affiliation:
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001 844 599 2273 (UCB) |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Drug: Certolizumab Pegol
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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