Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab

A Phase 3 study testing Certolizumab pegol in people with Crohn's Disease, run by UCB Pharma at 5 sites in Greece.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab 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
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 16 participants
Where: 5 sitesGreece
Study dates: Apr 2007to Aug 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant

Who cannot join

Symptomatic obstructive intestinal strictures
Bowel resection within 4 weeks
Current total parenteral nutrition
Short bowel syndrome
Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Greece5 sites

Study site
Athens
Study site
Heraklion, Crete
Study site
Ioannina
Study site
Piraeus
Study site
Thessaloniki

Other trials in Greece

About this study

Official title: Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab

Conditions: Crohn's Disease
Being tested: Certolizumab pegol
Keywords: Certolizumab pegol, Cimzia, Crohn's disease, Greek patients
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 pegolBiological
Also called Cimzia
certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12.
Treatment duration: 12 weeks.

Study groups in NCT00307931
Study group	Role	What they receive
Certolizumab pegol	Experimental	certolizumab pegol 400 mg Receives: Biological: Certolizumab pegol

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Baseline, Week 6

Secondary outcomes (11)

Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Baseline to Weeks 1, and 14 or Withdrawal
Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Baseline to Weeks 1, 6 and 14
Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Weeks 1, 6 and 14 or Withdrawal
Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Weeks 1, 2, 4, 6, 8, 12 and 14
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14
C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
Measured: Weeks 1, 2, 4, 6, 8, 12 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14
The IBDQ Total Score is the sum of 32 responses, each ranging from 0 to 7, thus the Total Score ranges from 0 to 224; a higher score indicating a better quality of life.
Measured: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14
The IBDQ Bowel Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Measured: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14
The IBDQ Systemic Symptoms Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Measured: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14
The IBDQ Emotional Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Measured: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14
The IBDQ Social Function Domain Score is the sum of 8 responses, each ranging from 0 to 7, thus the score ranges from 0 to 56; a higher score indicating a better quality of life.
Measured: Baseline, and Weeks 6 and 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Aug 2008

First posted28 Mar 2006 (estimated)
Study startApr 2007
Primary completionAug 2008
Study completionAug 2008

Why it stopped: Study was terminated early because of slow recruitment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Crohn's 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 16 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00307931
Sponsor's protocol ID: C87055
Other IDs: Eudract n° - 2006-002027-16
Status last verified: Dec 2009
First submitted: 24 Mar 2006
Last updated: 31 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Crohn's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Certolizumab Pegol in the Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Have Been Previously Treated Successfully With Infliximab But Who Have Subsequently Lost Response or Developed Intolerance to Infliximab
ClinicalTrials.gov ID: NCT00307931
Acronym / sponsor ID: C87055
Conditions: Crohn's Disease
Keywords: Certolizumab pegol, Cimzia, Crohn's disease, Greek patients
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study was terminated early because of slow recruitment
Enrolment: 16 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Aug 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 28 Mar 2006 (estimated)
Results: Posted 19 Oct 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Certolizumab pegol	Experimental	Biological: Certolizumab pegolcertolizumab pegol 400 mg

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant

Key exclusion criteria (5 listed)

Symptomatic obstructive intestinal strictures
Bowel resection within 4 weeks
Current total parenteral nutrition
Short bowel syndrome
Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.

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: Cimziacertolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12. Treatment duration: 12 weeks.	Biological	Certolizumab pegol

Primary outcome

Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6
Time frame: Baseline, Week 6
The CDAI score is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.

11 secondary outcomes

Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal
Time frame: Baseline to Weeks 1, and 14 or Withdrawal
Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14
Time frame: Baseline to Weeks 1, 6 and 14
Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal
Time frame: Weeks 1, 6 and 14 or Withdrawal
Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
Time frame: Weeks 1, 2, 4, 6, 8, 12 and 14
Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
Time frame: Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14
C-reactive Protein Level at Each of Weeks 1, 2, 4, 6, 8, 12 and 14
Time frame: Weeks 1, 2, 4, 6, 8, 12 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Baseline, and Weeks 6 and 14
Time frame: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptoms Domain Score at Baseline, and Weeks 6 and 14
Time frame: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Symptoms Domain Score at Baseline, and Weeks 6 and 14
Time frame: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Function Domain Score at Baseline, and Weeks 6 and 14
Time frame: Baseline, and Weeks 6 and 14
Inflammatory Bowel Disease Questionnaire (IBDQ) Social Function Domain Score at Baseline, and Weeks 6 and 14
Time frame: Baseline, and Weeks 6 and 14

Results and safety

Results posted to the registry on 19 Oct 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Certolizumab Pegol 400 mg	16	15

Primary outcome: Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6

Time frame: Baseline, Week 6. Number. Unit: participants

Measure	Certolizumab Pegol 400 mg n = 16
Value	7

Population analysed: This outcome is based on the Intent-to-Treat population, defined as all subjects who were enrolled and received at least 1 dose of study medication (N=16).

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected during the treatment period and safety follow-up period, namely until 12 weeks following the last dose of study medication for each subject (which could be a time frame up to 24 weeks).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Certolizumab Pegol 400 mg	3 of 16 (18.8%)	4 of 16 (25%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated early due to slow recruitment, namely only 17 subjects were recruited although the sample size had planned for approximately 50 subjects. As a consequence, the majority of secondary outcome measures were not summarized.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

Related trials for Crohn's Disease

Not yet recruitingPhase 1
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RecruitingObservational study
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RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
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RecruitingObservational study
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Enrolling by invitationPhase 4
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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 Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Certolizumab pegol in people with Crohn's Disease, run by UCB Pharma at 5 sites in Greece.

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 5 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: stopped early, as of the sponsor's last update on 31 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Yes. Results are posted in the registry (first posted 19 Oct 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6 (time frame: Baseline, Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00307931.

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 31 Aug 2011.