Crohn DiseasePhase 3NCT00354367
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas
A Phase 3 study testing Certolizumab pegol in people with Crohn Disease, run by UCB Pharma.
Trial summary
To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Certolizumab pegol
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2007to not given
- Phase
- Phase 3
- 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
- Patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of Crohn's disease
Who cannot join
- Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome.
- All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient.
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
About this study
Official title: A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.
To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.
- Conditions
- Crohn Disease
- Being tested
- Certolizumab pegol
- Keywords
- Crohn Disease, Certolizumab pegol, Fistula
- Medical subject headings
- Crohn Disease, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab pegolDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.
Secondary outcomes (1)
Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2006 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Krassimir Mitchev, MD, Study director, UCB / Global Medical Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00354367
- Sponsor's protocol ID
- C87058
- Status last verified
- May 2012
- First submitted
- 18 Jul 2006
- Last updated
- 28 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIB Multicenter, Open Label, Randomized Clinical Trial Evaluating Efficacy of Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor (TNF) in Crohn's Disease Patients With Draining Fistulas.
- ClinicalTrials.gov ID
- NCT00354367
- Acronym / sponsor ID
- C87058
- Conditions
- Crohn Disease
- Keywords
- Crohn Disease, Certolizumab pegol, Fistula
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- First posted
- 20 Jul 2006 (estimated)
- 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.
To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of Crohn's disease
Key exclusion criteria (3 listed)
- Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome.
- All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient.
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
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 pegol | Drug | – |
Primary outcome
Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.
1 secondary outcome
Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
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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.
Krassimir Mitchev, MD study director
UCB / Global Medical Affairs
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Certolizumab pegol in people with Crohn Disease, run by UCB Pharma.
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 3 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: withdrawn, as of the sponsor's last update on 28 May 2012. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.. It is what the study was designed to measure, not a finding.
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 28 May 2012.