- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03559660
CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
Study Overview
Study Type
Expanded Access Type
- Individual Patients
Contacts and Locations
Study Contact
- Name: UCB Cares
- Phone Number: 2273 +1 844 599
- Email: UCBCares@ucb.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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*:
- A medical history of or a recent (< 6 months) active tuberculosis (TB)
- A recent (<6 months) chest X-ray with signs consistent with TB infection
- 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.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Investigators
- Study Director: UCB Cares, 001 844 599 2273 (UCB)
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Crohn Disease
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tumor Necrosis Factor Inhibitors
- Certolizumab Pegol
Other Study ID Numbers
- C87092
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Massachusetts General HospitalAmerican College of GastroenterologyNot yet recruitingInflammatory Bowel Diseases | Crohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's EsophagitisUnited States
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