Crohn's DiseasePhase 3COSPAR1NCT00349752

Corticosteroid Sparing Effect of Certolizumab in Crohn's Disease

A Phase 3 study testing certolizumab pegol 400 mg in people with Crohn's Disease, run by UCB Pharma at 68 sites in 3 countries.

Terminated

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Crohn's Disease
What is being tested?: certolizumab pegol 400 mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 174 participants
Where: 68 sitesin 3 countries
Study dates: Nov 2006to Jul 2009
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

Men and women
Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)

Who cannot join

Active or draining fistula present at screening
Lactating and/or pregnant female subjects
A history of any health condition that could potentially interfere with the disease and/or the treatment
A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study
History of drug or alcohol abuse in the prior year
Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0

Trial locations and contacts

68 sites in 3 countries.

Country

City, postcode or hospital

68 sites in 3 countries

United States54 sites

Study site
Annapolis, Maryland
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Austin, Texas
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Birmingham, Alabama
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Bloomington, Indiana
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Bowling Green, Kentucky
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Burlington, Vermont
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Chapel Hill, North Carolina
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Charlotte, North Carolina
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Chesapeake, Virginia
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Chesterfield, Michigan
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Chicago, Illinois
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Cincinnati, Ohio
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Clearwater, Florida
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Cleveland, Ohio
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Columbia, South Carolina
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Dayton, Ohio
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Dearborn, Michigan
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Gainesville, Florida
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Germantown, Tennessee
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Golden, Colorado
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Hialeah, Florida
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Irving, Texas
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Jacksonville, Florida
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Kansas City, Missouri
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La Jolla, California
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Louisville, Kentucky
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Madison, Wisconsin
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Marietta, Georgia
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Metairie, Louisiana
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Mexico, Missouri
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Milwaukee, Wisconsin
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Monroe, Wisconsin
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Montgomery, Alabama
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New York, New York
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Newton, Massachusetts
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North Miami Beach, Florida
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Ocean Springs, Mississippi
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Oceanside, California
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Orange, California
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Palo Alto, California
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Raleigh, North Carolina
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Richmond, Virginia
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Rochester, Minnesota
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Roseville, California
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Salt Lake City, Utah
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Sarasota, Florida
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Savannah, Georgia
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Seattle, Washington
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Syracuse, New York
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Topeka, Kansas
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Troy, Michigan
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Tucson, Arizona
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Tulsa, Oklahoma
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Winter Park, Florida

Other trials in United States

Canada9 sites

Study site
Abbotsford British Columbia, British Columbia
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Calgary, Alberta
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Edmonton, Alberta
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Halifax, Nova Scotia
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London, Ontario
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Saskatoon, Saskatchewan
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Toronto, Ontario
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Vancouver, British Columbia
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Winnipeg, Manitoba

Other trials in Canada

Germany5 sites

Study site
Frankfurt
Study site
Heidleberg
Study site
Jena
Study site
Magdeburg
Study site
Ulm

Other trials in Germany

About this study

Official title: A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.

The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in subjects with moderate to severe Crohn's disease. Subjects had to be in remission (CDAI<=150) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization.

Conditions: Crohn's Disease
Being tested: certolizumab pegol 400 mg, Placebo
Keywords: certolizumab pegol, Cimzia, Crohn's Disease, Inflammatory Bowel Disease
Medical subject headings: Crohn Disease, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

certolizumab pegol 400 mgBiological
Also called Cimzia, CDP870, CZP
Certolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.
PlaceboOther
Placebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.

Study groups in NCT00349752
Study group	Role	What they receive
Certolizumab pegol 400 mg	Experimental	Certolizumab pegol 400 mg Receives: Biological: certolizumab pegol 400 mg
Placebo	Placebo comparator	Placebo Receives: Other: Placebo

What is being measured

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

Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.
Measured: Week 38

Secondary outcomes (10)

Percentage of Subjects With Continuous Remission Off Steroids at Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A subject with continuous remission off steroids at Week 38 is a subject in remission (CDAI =< 150) from the visit when he stops taking steroids to Week 38 and is off corticosteroids until Week 38.
Measured: Week 38
Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]
Measured: Week 38
Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
A subject with relapse/ treatment failure has a Crohn's Disease Activity Index (CDAI) > 150 and an increase in CDAI of >= 70 points versus Week 0. [The CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.]
Measured: During the 38-week double-blind treatment period
Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
The median weekly dose of corticosteroids is calculated for each subject, and these per-subject median values are further summarized by treatment group. The mean of the per-subject median doses in each treatment group is presented here.
Measured: Over the 38-week double-blind treatment period
Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
The cumulative dose of corticosteroids over the 48-week study period is calculated for each subject individually. The mean of these values for each treatment group is presented here.
Measured: Over the 48-week study period
Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
The run in period lasted a minimum of 1 week and a maximum of 6 weeks. During this period subjects were treated with any dose or type of systemic corticosteroids the Investigator felt was appropriate. To be eligible for study randomization, subjects must have been in remission (CDAI ≤150 points) and receiving corticosteroids at a dose no higher than 30 mg/day prednisone or equivalent during the week prior to randomization. Subjects who did not meet these criteria were not randomized and were withdrawn from the study.
Measured: 6-week run-in period, 38-week double-blind treatment period
Crohn's Disease Activity Index (CDAI) Score at Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Week 38
Change From Baseline in CDAI Score at Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Measured: Week 0, Week 38
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher score indicates a better quality of life. IBDQ remission is defined as a subject having an IBDQ total score >= 170 points.
Measured: Week 38
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
The total IBDQ score will be derived as the sum of the responses (each ranging from 1 to 7) to all 32 questions on the IBDQ and can therefore range from 32 to 224. A higher scores indicates a better quality of life. IBDQ response is defined as an increase from baseline in the IBDQ total score >= 16 points.
Measured: Week 0, Week 38

Timeline

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

Nov 2006Jul 2009

First posted10 Jul 2006 (estimated)
Study startNov 2006
Primary completionJul 2009
Study completionJul 2009

Why it stopped: Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited

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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00349752
Sponsor's protocol ID: C87059
Other IDs: 2006-003870-88
Acronym: COSPAR1
Status last verified: Oct 2010
First submitted: 30 Jun 2006
Last updated: 9 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Expanded access: Available

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 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease.
ClinicalTrials.gov ID: NCT00349752
Acronym / sponsor ID: COSPAR1 / C87059
Conditions: Crohn's Disease
Keywords: certolizumab pegol, Cimzia, Crohn's Disease, Inflammatory Bowel Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for subjects already recruited
Enrolment: 174 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Study start: Nov 2006
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 10 Jul 2006 (estimated)
Results: Posted 1 Dec 2010

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: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Certolizumab pegol 400 mg	Experimental	Biological: certolizumab pegol 400 mgCertolizumab pegol 400 mg
Placebo	Placebo comparator	Other: PlaceboPlacebo

Who may qualify

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

Key inclusion criteria (2 listed)

Men and women
Age 18 years or older with moderate to severe Crohn's disease (Crohn's Disease Activity Index (CDAI) score of ≥ 220 ≤450)

Key exclusion criteria (7 listed)

Active or draining fistula present at screening
Lactating and/or pregnant female subjects
A history of any health condition that could potentially interfere with the disease and/or the treatment
A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product
Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study

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 400 mgAlso: Cimzia, CDP870, CZPCertolizumab pegol 400 mg provided in solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.	Biological	Certolizumab pegol 400 mg
PlaceboPlacebo (commercially available sodium chloride 0.9% (preservative free)) provided for subcutaneous injection in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36. Two vials will be required for each dosing.	Other	Placebo

Primary outcome

Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38
Time frame: Week 38
The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates disease remission and a score above 450 indicates extremely severe disease.

10 secondary outcomes

Percentage of Subjects With Continuous Remission Off Steroids at Week 38
Time frame: Week 38
Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38
Time frame: Week 38
Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period
Time frame: During the 38-week double-blind treatment period
Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
Time frame: Over the 38-week double-blind treatment period
Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period
Time frame: Over the 48-week study period
Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period
Time frame: 6-week run-in period, 38-week double-blind treatment period
Crohn's Disease Activity Index (CDAI) Score at Week 38
Time frame: Week 38
Change From Baseline in CDAI Score at Week 38
Time frame: Week 0, Week 38
Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Time frame: Week 38
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38
Time frame: Week 0, Week 38

Results and safety

Results posted to the registry on 1 Dec 2010, 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	87	28
Placebo	87	23

Primary outcome: Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38

Time frame: Week 38. Number. Unit: percentage of subjects

Measure	Certolizumab Pegol 400 mg n = 87	Placebo n = 87
Value	26.4	21.8

Population analysed: Intention-to-treat (ITT) population which consists of all randomized subjects who received at least one injection of study medication. In the analyses of remission rates, subjects for whom it is impossible to assess the remission status will be conservatively considered as non-remitters in the calculations.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48-week study period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Certolizumab Pegol 400 mg	9 of 87 (10.3%)	70 of 87 (80.5%)	Not reported
Placebo	8 of 87 (9.2%)	73 of 87 (83.9%)	Not reported

Limitations and caveats (from the sponsor): Recruitment was stopped early due to slow enrolment of this population. With no safety concerns, the study continued normally for the 174 subjects already recruited. Results should be treated with caution due to the early termination of this study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
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

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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)

68 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing certolizumab pegol 400 mg in people with Crohn's Disease, run by UCB Pharma at 68 sites in 3 countries.

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 2 inclusion and 7 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 9 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 68 sites in United States, Canada, Germany. 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. Some participants in this study may receive a placebo. 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 1 Dec 2010). 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?

Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38 (time frame: Week 38). 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 NCT00349752.

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 9 Aug 2018.