NCT00152490

Brief Summary

A 26 week study to examine the efficacy, safety and pharmacokinetics of CDP870 in Crohn's disease

Trial Health

100
On Track

Trial Health Score

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

Enrollment
604

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Dec 2003

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

December 1, 2003

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2005

Completed
Last Updated

September 9, 2013

Status Verified

February 1, 2010

Enrollment Period

1.4 years

First QC Date

September 8, 2005

Last Update Submit

September 6, 2013

Conditions

Crohn's Disease

Keywords

Crohn's disease, CDP870, CDAI, clinical response, remission,Certolizumab Pegol, Cimzia

Outcome Measures

Primary Outcomes (3)

  • In the population with CRP ≥ 10 mg/L at baseline

  • Clinical response at week 6

  • Clinical response at week 6 and week 26

Secondary Outcomes (1)

  • In the population with CRP ≥ 10 mg/L at baseline - % patients in clinical remission at Week 6; % patients in clinical remission at both Week 6 and Week 26; % patients with IBDQ response at Week 6; % patients with IBDQ response at both Week 6 and Week 2

Interventions

Certolizumab Pegol (CDP870)DRUG

Eligibility Criteria

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

You may qualify if:

  • Definitive diagnosis of Crohn's disease confirmed (at least 3 months prior to study entry) either by radiological, endoscopic or histological evidence, affecting the terminal ileum (L1), colon (L2) or ileocolon (L3\*. \*Vienna Classification (1998)
  • Active Crohn's disease (≥ 220 and ≤ 450) scored over the 7 days prior to the first dose of study drug.
  • Male and female aged 18 years or above at screening.
  • Patients who meet all concomitant medication criteria in the protocol specified table. For all drugs being taken at screening, the patient should be able to remain on a stable dose throughout the duration of the study, although steroids may be tapered starting at Weeks 8 to 12.

You may not qualify if:

  • Crohn's Disease Related
  • Fistula abscess present at screening.
  • Stricturing type disease with symptoms or signs of non-inflammatory mechanical obstruction or bowel perforation in last 3 months.
  • Short bowel syndrome.
  • Functional colostomy or ileostomy (note: patients who have had a temporary stoma in the past, which has been reversed, are eligible to enter the study).
  • Positive stool laboratory results for enteric pathogens.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Sandborn WJ, Feagan BG, Stoinov S, Honiball PJ, Rutgeerts P, Mason D, Bloomfield R, Schreiber S; PRECISE 1 Study Investigators. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. 2007 Jul 19;357(3):228-38. doi: 10.1056/NEJMoa067594.

    PMID: 17634458RESULT

  • Rutgeerts P, Schreiber S, Feagan B, Keininger DL, O'Neil L, Fedorak RN; CDP870 Crohn's Disease Study Group. Certolizumab pegol, a monthly subcutaneously administered Fc-free anti-TNFalpha, improves health-related quality of life in patients with moderate to severe Crohn's disease. Int J Colorectal Dis. 2008 Mar;23(3):289-96. doi: 10.1007/s00384-007-0395-7. Epub 2007 Dec 11.

    PMID: 18071721RESULT

  • Reilly MC, Gerlier L, Brabant Y, Brown M. Validity, reliability, and responsiveness of the work productivity and activity impairment questionnaire in Crohn's disease. Clin Ther. 2008 Feb;30(2):393-404. doi: 10.1016/j.clinthera.2008.02.016.

    PMID: 18343277RESULT

  • Lewis JD. Anti-TNF antibodies for Crohn's disease--in pursuit of the perfect clinical trial. N Engl J Med. 2007 Jul 19;357(3):296-8. doi: 10.1056/NEJMe078111. No abstract available.

    PMID: 17634466DERIVED

MeSH Terms

Conditions

Crohn DiseaseAnemia, Dyserythropoietic, Congenital

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesAnemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

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

Study Officials

  • UCB Clinical Trial Call Center

    UCB Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 9, 2005

Study Start

December 1, 2003

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

September 9, 2013

Record last verified: 2010-02