NCT00297648

Brief Summary

The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2006

Typical duration for phase_3

Geographic Reach
3 countries

19 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 28, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
2 months until next milestone

Results Posted

Study results publicly available

January 18, 2010

Completed
Last Updated

August 31, 2011

Status Verified

February 1, 2011

Enrollment Period

1.9 years

First QC Date

February 27, 2006

Results QC Date

December 10, 2009

Last Update Submit

August 30, 2011

Conditions

Crohn's Disease

Keywords

Certolizumab pegolCrohn's diseaseMucosal healing

Outcome Measures

Primary Outcomes (2)

  • Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments

    The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.

    Baseline, Week 10

  • Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments

    The CDEIS (Crohn's Disease Endoscopic Index of Severity) score provides a measure of mucosal inflammation. Generally, scores range from 0-30. A higher score indicates more severe mucosal inflammation, thus a negative change from Baseline (i.e., Week 10 score minus Baseline score) indicates improvement.

    Baseline, Week 10

Secondary Outcomes (34)

  • Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments

    Week 10

  • Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments

    Week 10

  • Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments

    Week 54

  • Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments

    Week 54

  • Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments

    Baseline, Week 10

  • +29 more secondary outcomes

Study Arms (1)

CDP870 400 mg

EXPERIMENTAL

Certolizumab pegol (CDP870) 400 mg

Biological: Certolizumab pegol

Interventions

Certolizumab pegolBIOLOGICAL

Certolizumab pegol (CDP870) 400 mg administered subcutaneously (sc) at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug end, either Q4W or Q2W, according to their administration frequency at Week 52.

Also known as: Cimzia, CZP, CDP870
CDP870 400 mg

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from active Crohn's disease \[Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450\] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
  • Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy

You may not qualify if:

  • Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
  • History of tuberculosis or positive tests for tuberculosis at screening
  • All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
  • Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Unknown Facility

Bonheiden, Belgium

Location

Unknown Facility

Brussels, Belgium

Location

Unknown Facility

Edegem, Belgium

Location

Unknown Facility

Leuven, Belgium

Location

Unknown Facility

Amiens, France

Location

Unknown Facility

Besançon, France

Location

Unknown Facility

Chambray-lès-Tours, France

Location

Unknown Facility

Clichy, France

Location

Unknown Facility

Grenoble, France

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Marseille, France

Location

Unknown Facility

Nice, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Reims, France

Location

Unknown Facility

Rouen, France

Location

Unknown Facility

Strasbourg, France

Location

Unknown Facility

Vandœuvre-lès-Nancy, France

Location

Unknown Facility

Berlin, Germany

Location

Unknown Facility

Bonn, Germany

Location

Related Publications (2)

  • Colombel JF, Sandborn WJ, Allez M, Dupas JL, Dewit O, D'Haens G, Bouhnik Y, Parker G, Pierre-Louis B, Hebuterne X. Association between plasma concentrations of certolizumab pegol and endoscopic outcomes of patients with Crohn's disease. Clin Gastroenterol Hepatol. 2014 Mar;12(3):423-31.e1. doi: 10.1016/j.cgh.2013.10.025. Epub 2013 Nov 1.

    PMID: 24184736DERIVED

  • Hebuterne X, Lemann M, Bouhnik Y, Dewit O, Dupas JL, Mross M, D'Haens G, Mitchev K, Ernault E, Vermeire S, Brixi-Benmansour H, Moreels TG, Mary JY, Marteau P, Colombel JF. Endoscopic improvement of mucosal lesions in patients with moderate to severe ileocolonic Crohn's disease following treatment with certolizumab pegol. Gut. 2013 Feb;62(2):201-8. doi: 10.1136/gutjnl-2012-302262. Epub 2012 Apr 23.

    PMID: 22525883DERIVED

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Polyethylene GlycolsPolymersMacromolecular SubstancesImmunoglobulin Fab FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
UCB Clinical Trial Call Center
Organization
UCB Pharma
+1 877 822 9493

Study Officials

  • UCB Clinical Trial Call Center

    +1 877 822 9493 (UCB)

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2006

First Posted

February 28, 2006

Study Start

February 1, 2006

Primary Completion

January 1, 2008

Study Completion

December 1, 2009

Last Updated

August 31, 2011

Results First Posted

January 18, 2010

Record last verified: 2011-02

Locations

FR(13)DE(2)BE(4)