Crohn's DiseasePhase 3COSPAR IINCT00356408
Examining the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Crohn's Disease
A Phase 3 study testing Certolizumab pegol in people with Crohn's Disease, run by UCB Pharma at 63 sites in 3 countries.
Trial summary
This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752). 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
- 106 participants
- Where
- 63 sitesin 3 countries
- Study dates
- Jan 2007to Feb 2010
- 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
- Patients previously enrolled in C87059 (COSPAR I, NCT00349752)
Who cannot join
- Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
- Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
- Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
Trial locations and contacts
63 sites in 3 countries.
63 sites in 3 countries
United States49 sites
Study site
Annapolis, Maryland
Study site
Austin, Texas
Study site
Birmingham, Alabama
Study site
Bloomington, Indiana
Study site
Bowling Green, Kentucky
Study site
Burlington, Vermont
Study site
Chapel Hill, North Carolina
Study site
Charlotte, North Carolina
Study site
Chesapeake, Virginia
Study site
Chesterfield, Michigan
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Clearwater, Florida
Study site
Cleveland, Ohio
Study site
Columbia, South Carolina
Study site
Davenport, Iowa
Study site
Dayton, Ohio
Study site
Dearborn, Michigan
Study site
Gainesville, Florida
Study site
Germantown, Tennessee
Study site
Hialeah, Florida
Study site
Jacksonville, Florida
Study site
Kansas City, Missouri
Study site
La Jolla, California
Study site
Lakewood, Colorado
Study site
Louisville, Kentucky
Study site
Marietta, Georgia
Study site
Metairie, Louisiana
Study site
Mexico, Missouri
Study site
Milwaukee, Wisconsin
Study site
Minneapolis, Minnesota
Study site
Monroe, Wisconsin
Study site
Montgomery, Alabama
Study site
New York, New York
Study site
Newton, Massachusetts
Study site
North Miami Beach, Florida
Study site
Oceanside, California
Study site
Palo Alto, California
Study site
Raleigh, North Carolina
Study site
Richmond, Virginia
Study site
Rochester, Minnesota
Study site
Roseville, California
Study site
Salt Lake City, Utah
Study site
Savannah, Georgia
Study site
Seattle, Washington
Study site
Syracuse, New York
Study site
Topeka, Kansas
Study site
Troy, Michigan
Study site
Tulsa, Oklahoma
Canada9 sites
Study site
Abbottsford, British Columbia
Study site
Calgary
Study site
Edmonton, Alberta
Study site
Halifax, Nova Scotia
Study site
London, Ontario
Study site
Saskatoon, Saskatchewan
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Winnipeg, Manitoba
Germany5 sites
Study site
Frankfurt
Study site
Heidelberg
Study site
Jena
Study site
Rostock
Study site
Ulm
About this study
Official title: An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).
This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).
- Conditions
- Crohn's Disease
- Being tested
- Certolizumab pegol
- Keywords
- CDP870, certolizumab pegol, Crohn's Disease
- 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 CDP870, CZP, Cimzia
Certolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg).
Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2.
| Study group | Role | What they receive |
|---|---|---|
| CDP870 400 mg | Experimental | Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2 Receives: Biological: Certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
Measured: During this study (maximum 122 weeks)
Secondary outcomes (1)
Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.
Crohn's disease activity index (CDAI) is used to quantify the symptoms of Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. Results are presented as the percentage of subjects in disease remission at Week 34.
Measured: Week 34 in this study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2006 (estimated)
- Study startJan 2007
- Primary completionFeb 2010
- Study completionFeb 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00356408
- Sponsor's protocol ID
- C87065
- Other IDs
- 2006-003871-11
- Acronym
- COSPAR II
- Status last verified
- Apr 2011
- First submitted
- 25 Jul 2006
- Last updated
- 9 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
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
- An Open-label, Multi-center Trial to Examine the Long Term Safety, Efficacy, and Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease Previously Enrolled in C87059 (COSPAR I, NCT00349752).
- ClinicalTrials.gov ID
- NCT00356408
- Acronym / sponsor ID
- COSPAR II / C87065
- Conditions
- Crohn's Disease
- Keywords
- CDP870, certolizumab pegol, Crohn's Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Jul 2006 (estimated)
- Results
- Posted 25 May 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label extension study designed to measure the safety, efficacy, and corticosteroid-sparing effect of certolizumab pegol (CDP870) in patients with moderate to severe Crohn's disease previously enrolled in C87059 (COSPAR I, NCT00349752).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDP870 400 mg | Experimental | Biological: Certolizumab pegolCertolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients previously enrolled in C87059 (COSPAR I, NCT00349752)
Key exclusion criteria (3 listed)
- Subject withdrawn or discontinued from C87059 (COSPAR I, NCT00349752) study under specific conditions
- Subject who received treatment other than study medication and other than medications permitted in C87059 (COSPAR I, NCT00349752)
- Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment
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: CDP870, CZP, CimziaCertolizumab pegol (CDP870), an anti-tumor necrosis factor (TNF)α, humanized antibody Fab' fragment - polyethylene glycol conjugate, solution for injection, in 10 mM sodium acetate buffer and 125 mM sodium chloride, pH 4.7, supplied in 3 mL vials with a fill of 1.4 mL (an extractable volume of 1 mL corresponds to a dose of 200 mg). Dosing is every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn's disease indication in the patient's country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2. | Biological | CDP870 400 mg |
Primary outcome
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks)
Time frame: During this study (maximum 122 weeks)
Results are presented as the number of subjects with at least one treatment-emergent adverse event during this study.
1 secondary outcome
Disease Remission (Crohn's Disease Activity Index, CDAI≤150) at Week 34 in Patients Who Completed/Did Not Complete C87059 (COSPAR I, NCT00349752) and Remained Off Corticosteroids.
Time frame: Week 34 in this study
Results and safety
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.
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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)
63 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 in people with Crohn's Disease, run by UCB Pharma at 63 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 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: finished, 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 63 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. 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 25 May 2011). 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?
Occurrence of at Least One Treatment-emergent Adverse Event During This Study (Maximum 122 Weeks) (time frame: During this study (maximum 122 weeks)). 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 9 Aug 2018.