Crohn's DiseaseCOMPASNCT03559660
CUP Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
A study testing Certolizumab Pegol in people with Crohn's Disease, run by UCB Biopharma SRL.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Certolizumab Pegol
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patient comes from ending open label studies such as WELCOME -C87046, COSPAR - C87065, MUSIC - C87043, PRECISE 3 - C87033, PRECISE 4 - C87034 and C87088
Who cannot join
- 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*:
Show all 20Show fewer
- 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.
About this study
Official title: Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
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
- Being tested
- Certolizumab Pegol
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab PegolDrug
Also called Cimzia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by UCB Biopharma SRLThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- UCB Biopharma SRL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Cares, Study director, 001 844 599 2273 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559660
- Sponsor's protocol ID
- C87092
- Acronym
- COMPAS
- Status last verified
- Jun 2025
- First submitted
- 5 Jun 2018
- Last updated
- 11 Jun 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Compassionate Use Program Certolizumab Pegol (CDP-870) in Adults Suffering From Crohn's Disease (CD)
- ClinicalTrials.gov ID
- NCT03559660
- Acronym / sponsor ID
- COMPAS / C87092
- Conditions
- Crohn's Disease
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- UCB Biopharma SRLIndustry (pharma, biotech, devices)
- First posted
- 18 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient comes from ending open label studies such as WELCOME -C87046, COSPAR - C87065, MUSIC - C87043, PRECISE 3 - C87033, PRECISE 4 - C87034 and C87088
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab PegolAlso: Cimzia | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Cares study director
001 844 599 2273 (UCB)
Questions about this trial
What is this clinical trial studying?
A study testing Certolizumab Pegol in people with Crohn's Disease, run by UCB Biopharma SRL.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.