NCT00307931

Brief Summary

An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to infliximab but who no longer have a sustained response or became intolerant to infliximab

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

5 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
1 year until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 19, 2009

Completed
Last Updated

August 31, 2011

Status Verified

December 1, 2009

Enrollment Period

1.3 years

First QC Date

March 24, 2006

Results QC Date

September 8, 2009

Last Update Submit

August 30, 2011

Conditions

Crohn's Disease

Keywords

Certolizumab pegolCimziaCrohn's diseaseGreek patients

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 6

    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.

    Baseline, Week 6

Secondary Outcomes (11)

  • Number of Patients With at Least a 100-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, and 14 or Withdrawal

    Baseline to Weeks 1, and 14 or Withdrawal

  • Number of Patients With at Least a 70-point Decrease From Baseline in Crohn's Disease Activity Index (CDAI) Score at Weeks 1, 6 and 14

    Baseline to Weeks 1, 6 and 14

  • Number of Patients With a Crohn's Disease Activity Index (CDAI) Score ≤150 (Remission) at Weeks 1, 6 and 14 or Withdrawal

    Weeks 1, 6 and 14 or Withdrawal

  • Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14

    Weeks 1, 2, 4, 6, 8, 12 and 14

  • Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Each of Weeks 1, 2, 4, 6, 8, 12 and 14

    Baseline to Weeks 1, 2, 4, 6, 8, 12 and 14

  • +6 more secondary outcomes

Study Arms (1)

Certolizumab pegol

EXPERIMENTAL

certolizumab pegol 400 mg

Biological: Certolizumab pegol

Interventions

Certolizumab pegolBIOLOGICAL

certolizumab pegol 400 mg (lyophilized product) administered as 2 x 200 mg subcutaneous injections at Weeks 0, 2, 4, 8 and 12. Treatment duration: 12 weeks.

Also known as: Cimzia
Certolizumab pegol

Eligibility Criteria

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

You may qualify if:

  • Adult men and women with Crohn's disease previously responsive to infliximab who became non-responsive or intolerant

You may not qualify if:

  • Symptomatic obstructive intestinal strictures
  • Bowel resection within 4 weeks
  • Current total parenteral nutrition
  • Short bowel syndrome
  • Concomitant disease or pathological condition that could interfere with Crohn's disease or to be harmful for the well being of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Heraklion, Crete, Greece

Location

Unknown Facility

Athens, Greece

Location

Unknown Facility

Ioannina, Greece

Location

Unknown Facility

Piraeus, Greece

Location

Unknown Facility

Thessaloniki, Greece

Location

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

Limitations and Caveats

This study was terminated early due to slow recruitment, namely only 17 subjects were recruited although the sample size had planned for approximately 50 subjects. As a consequence, the majority of secondary outcome measures were not summarized.

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

March 24, 2006

First Posted

March 28, 2006

Study Start

April 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

August 31, 2011

Results First Posted

October 19, 2009

Record last verified: 2009-12

Locations

GR(5)