CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)

NCT03559660 | Unknown

• 1 other identifier: C87092
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Crohn's Disease

Interventions

Certolizumab Pegol DRUG

Also known as: Cimzia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Biopharma SRL: lead

MeSH Terms

Conditions

Crohn Disease

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 18, 2018
• Last Updated: June 11, 2025

Record last verified: 2025-06