Crohn's DiseasePhase 3NCT00308581
Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
A Phase 3 study testing Certolizumab pegol in people with Crohn's Disease, run by UCB Pharma at 107 sites in 14 countries.
Trial summary
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 539 participants
- Where
- 107 sitesin 14 countries
- Study dates
- Apr 2006to Apr 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
- Subjects with Crohn's Disease
- Previous treatment failure to Infliximab (intolerance and/or no response)
Who cannot join
- Obstructive intestinal strictures
- Recent bowel resection
- Proctocolectomy or total colectomy
- Current total parenteral nutrition
- Short bowel syndrome
- All 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
Trial locations and contacts
107 sites in 14 countries.
107 sites in 14 countries
United States31 sites
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Baton Rouge, Louisiana
Study site
Boston, Massachusetts
Study site
Chapel Hill, North Carolina
Study site
Charleston, South Carolina
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Dallas, Texas
Study site
Gainesville, Florida
Study site
Galveston, Texas
Study site
Germantown, Tennessee
Study site
Great Neck, New York
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Kingsport, Tennessee
Study site
Lexington, Kentucky
Study site
Lincoln, Nebraska
Study site
Louisville, Kentucky
Study site
Milwaukee, Wisconsin
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Oklahoma City, Oklahoma
Study site
Philadelphia, Pennsylvania
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Rochester, Minnesota
Study site
San Francisco, California
Study site
Seattle, Washington
France10 sites
Study site
Amiens
Study site
Clichy
Study site
Grenoble
Study site
Lille
Study site
Montpellier, Cédex 5
Study site
Nice, Cedex 3
Study site
Paris
Study site
Pessac
Study site
Rouen
Study site
Toulouse
Germany9 sites
Study site
Berlin
Study site
Hamburg
Study site
Hanover
Study site
Herne
Study site
Kiel
Study site
Leipzig
Study site
Minden
Study site
München
Study site
Munich
Belgium8 sites
Study site
Bonheiden
Study site
Brussels
Study site
Genk
Study site
Ghent
Study site
Kortrijk
Study site
Leuven
Study site
Liège
Study site
Roeselare
Italy7 sites
Study site
Bari
Study site
Bologna
Study site
Milan
Study site
Padova
Study site
Palermo
Study site
Roma
Study site
Torino
Netherlands7 sites
Study site
Amsterdam
Study site
Eindhoven
Study site
Enschede
Study site
Heerlen
Study site
Leiden
Study site
Terneuven
Study site
Zwolle
United Kingdom7 sites
Study site
Bristol
Study site
Cambridge
Study site
Edinburgh
Study site
London
Study site
Nottingham
Study site
Oxford
Study site
Sheffield
Canada6 sites
Study site
Calgary
Study site
Edmonton, Alberta
Study site
London, Ontario
Study site
Richmond, Ontario
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Spain6 sites
Study site
Barcelona
Study site
Madrid
Study site
Oviedo
Study site
Santiago de Compostela
Study site
Seville
Study site
Valencia
Denmark4 sites
Study site
Aalborg
Study site
Aarhus
Study site
Copenhagen
Study site
Herlev
Sweden4 sites
Study site
Gothenburg
Study site
Malmö
Study site
Örebro
Study site
Stockholm
About this study
Official title: Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
- Conditions
- Crohn's Disease
- Being tested
- Certolizumab pegol, Placebo
- Keywords
- Crohn's Disease, 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 pegolBiological
Also called CDP870, Cimzia
400mg Certolizumab Pegol, Q4W, administered 4-weekly
Certolizumab pegolBiological
Also called CDP870, Cimzia
400mg Certolizumab Pegol, Q2W, administered 2-weekly
PlaceboOther
placebo administered 4-weekly in Active 1
| Study group | Role | What they receive |
|---|---|---|
| Active 1 | Experimental | Q4W regimen
- every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol Receives: Biological: Certolizumab pegol; Other: Placebo |
| Active 2 | Experimental | Q2W regimen
- every 2 weeks: 400 mg Certolizumab Pegol Receives: Biological: Certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response.
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 Week 6
Secondary outcomes (64)
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Response is defined as at least 100 point decrease in CDAI score from baseline. 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 Week 26
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
Response is defined as at least 70 points reduction in CDAI score. 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 Week 6
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
Response is defined as at least 70 points reduction in CDAI score. 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 Week 26
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
Remission is defined as CDAI score ≤ 150. 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: Week 6
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms 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: Week 26
CDAI Score at Week 2 of the Induction Phase
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: Week 2
CDAI Score at Week 4 of the Induction Phase
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: Week 4
CDAI Score at Week 6 of the Induction Phase
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: Week 6
CDAI Score at Week 8 in the Randomized Maintenance Phase
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: Week 8
CDAI Score at Week 10 in the Randomized Maintenance Phase
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: Week 10
CDAI Score at Week 12 in the Randomized Maintenance Phase
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: Week 12
CDAI Score at Week 14 in the Randomized Maintenance Phase
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: Week 14
CDAI Score at Week 16 in the Randomized Maintenance Phase
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: Week 16
CDAI Score at Week 18 in the Randomized Maintenance Phase
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: Week 18
CDAI Score at Week 20 in the Randomized Maintenance Phase
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: Week 20
CDAI Score at Week 22 in the Randomized Maintenance Phase
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: Week 22
CDAI Score at Week 24 in the Randomized Maintenance Phase
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: Week 24
CDAI Score at Week 26 in the Randomized Maintenance Phase
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: Week 26
Change From Baseline in CDAI Score at Week 2 of the Induction Phase
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 Week 2
Change From Baseline in CDAI Score at Week 4 of the Induction Phase
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 Week 4
Change From Baseline in CDAI Score at Week 6 of the Induction Phase
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 Week 6
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
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 Week 8
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
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 Week 10
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
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 Week 12
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
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 Week 14
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
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 Week 16
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
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 Week 18
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
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 Week 20
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
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 Week 22
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
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 Week 24
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
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 Week 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Remission is defined as CDAI score ≤ 150.
Measured: Week 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Measured: Week 26
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 0
CRP Level at Week 2 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 2
CRP Level at Week 4 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 4
CRP Level at Week 6 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 6
CRP Level at Week 8 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 8
CRP Level at Week 10 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 10 (optional measurement)
CRP Level at Week 12 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 12
CRP Level at Week 14 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 14 (optional measurement)
CRP Level at Week 16 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 16
CRP Level at Week 18 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 18 (optional measurement)
CRP Level at Week 20 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 20
CRP Level at Week 22 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 22 (optional measurement)
CRP Level at Week 24 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 24
CRP Level at Week 26 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Measured: Week 26
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.
Measured: Last visit on or before Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionApr 2008
- Study completionApr 2008
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.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 539 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
- NCT00308581
- Sponsor's protocol ID
- C87042
- Other IDs
- Eudract number: 2005-004104-37
- Status last verified
- Apr 2011
- First submitted
- 28 Mar 2006
- Last updated
- 7 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Expanded access
- Available
Publications
Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24. doi: 10.1177/147323001003800402.
PubMed 20925993Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.
PubMed 20451663Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
PubMed 21223344
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIb Open-label Induction and Double-blind Comparison of 2 Maintenance Schedules Evaluating Clinical Benefit and Tolerability of Certolizumab Pegol in Crohn's Disease Patients With Prior Loss of Response or Intolerance to Infliximab
- ClinicalTrials.gov ID
- NCT00308581
- Acronym / sponsor ID
- C87042
- Conditions
- Crohn's Disease
- Keywords
- Crohn's Disease, Certolizumab pegol
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 29 Mar 2006 (estimated)
- Results
- Posted 17 Nov 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active 1 | Experimental | Biological: Certolizumab pegol, Other: PlaceboQ4W regimen - every 4 weeks: alternatively placebo and 400mg Certolizumab Pegol |
| Active 2 | Experimental | Biological: Certolizumab pegolQ2W regimen - every 2 weeks: 400 mg Certolizumab Pegol |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with Crohn's Disease
- Previous treatment failure to Infliximab (intolerance and/or no response)
Key exclusion criteria (7 listed)
- Obstructive intestinal strictures
- Recent bowel resection
- Proctocolectomy or total colectomy
- Current total parenteral nutrition
- Short bowel syndrome
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, Cimzia400mg Certolizumab Pegol, Q4W, administered 4-weekly | Biological | Active 1 |
| Certolizumab pegolAlso: CDP870, Cimzia400mg Certolizumab Pegol, Q2W, administered 2-weekly | Biological | Active 2 |
| Placeboplacebo administered 4-weekly in Active 1 | Other | Active 1 |
Primary outcome
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase
Time frame: Baseline to Week 6
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. 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.
64 secondary outcomes
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Time frame: Baseline to Week 26
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
Time frame: Baseline to Week 6
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
Time frame: Baseline to Week 26
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
Time frame: Week 6
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
Time frame: Week 26
CDAI Score at Week 2 of the Induction Phase
Time frame: Week 2
CDAI Score at Week 4 of the Induction Phase
Time frame: Week 4
CDAI Score at Week 6 of the Induction Phase
Time frame: Week 6
CDAI Score at Week 8 in the Randomized Maintenance Phase
Time frame: Week 8
CDAI Score at Week 10 in the Randomized Maintenance Phase
Time frame: Week 10
CDAI Score at Week 12 in the Randomized Maintenance Phase
Time frame: Week 12
CDAI Score at Week 14 in the Randomized Maintenance Phase
Time frame: Week 14
CDAI Score at Week 16 in the Randomized Maintenance Phase
Time frame: Week 16
CDAI Score at Week 18 in the Randomized Maintenance Phase
Time frame: Week 18
CDAI Score at Week 20 in the Randomized Maintenance Phase
Time frame: Week 20
CDAI Score at Week 22 in the Randomized Maintenance Phase
Time frame: Week 22
CDAI Score at Week 24 in the Randomized Maintenance Phase
Time frame: Week 24
CDAI Score at Week 26 in the Randomized Maintenance Phase
Time frame: Week 26
Change From Baseline in CDAI Score at Week 2 of the Induction Phase
Time frame: Baseline to Week 2
Change From Baseline in CDAI Score at Week 4 of the Induction Phase
Time frame: Baseline to Week 4
Change From Baseline in CDAI Score at Week 6 of the Induction Phase
Time frame: Baseline to Week 6
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
Time frame: Baseline to Week 8
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
Time frame: Baseline to Week 10
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
Time frame: Baseline to Week 12
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
Time frame: Baseline to Week 14
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
Time frame: Baseline to Week 16
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
Time frame: Baseline to Week 18
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
Time frame: Baseline to Week 20
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
Time frame: Baseline to Week 22
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
Time frame: Baseline to Week 24
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
Time frame: Baseline to Week 26
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 10
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 12
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 14
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 16
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 18
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 20
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 22
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 24
Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline.
Time frame: Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20925993Taylor P, Manger B, Alvaro-Gracia J, Johnstone R, Gomez-Reino J, Eberhardt E, Wolfe F, Schwartzman S, Furfaro N, Kavanaugh A. Patient perceptions concerning pain management in the treatment of rheumatoid arthritis. J Int Med Res. 2010 Jul-Aug;38(4):1213-24. doi: 10.1177/147323001003800402.
- Results publication: PubMed 20451663Sandborn WJ, Abreu MT, D'Haens G, Colombel JF, Vermeire S, Mitchev K, Jamoul C, Fedorak RN, Spehlmann ME, Wolf DC, Lee S, Rutgeerts P. Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab. Clin Gastroenterol Hepatol. 2010 Aug;8(8):688-695.e2. doi: 10.1016/j.cgh.2010.04.021. Epub 2010 May 6.
- Results publication: PubMed 21223344Feagan BG, Sandborn WJ, Wolf DC, Coteur G, Purcaru O, Brabant Y, Rutgeerts PJ. Randomised clinical trial: improvement in health outcomes with certolizumab pegol in patients with active Crohn's disease with prior loss of response to infliximab. Aliment Pharmacol Ther. 2011 Mar;33(5):541-50. doi: 10.1111/j.1365-2036.2010.04568.x. Epub 2011 Jan 12.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
Related trials for Crohn's Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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)
107 sites in 14 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 107 sites in 14 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: finished, as of the sponsor's last update on 7 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 107 sites in United States, France, Germany, Belgium, Italy and 9 more countries. 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 17 Nov 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?
Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase (time frame: Baseline to 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 NCT00308581, which also lists 3 linked publications.
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 7 Aug 2018.