Evaluate Efficacy of Certolizumab in Crohn's Patients Wit... | NCT00354367

Studies
Evaluate Efficacy of Certolizumab in Crohn's Patients With Draining Fistulas

NCT00354367

Sponsor

UCB Pharma

Status

Withdrawn

Last Update Posted

May 28, 2012Estimated

Enrollment

0Actual

Phase

Phase 3

Conditions

Crohn Disease

Interventions

Certolizumab pegol

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 18, 2006

First Submission Date that Met QC Criteria

Jul 18, 2006

First Posted Date

Jul 20, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2012

Last Update Posted Date

May 28, 2012Estimated

Description Module

Brief Summary

To investigate the clinical efficacy of certolizumab pegol for fistula closure in Crohn's disease subjects with active draining fistulas.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Name	Type	Description	Arm Group Labels	Other Names
Certolizumab pegol	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Investigation of Clinical efficacy of certolizumab pegol for fistula closure, as measured by the proportion of patients with fistula improvement after 16 weeks of treatment.

Secondary Outcomes

Measure	Description	Time Frame
Investigation of Clinical efficacy of certolizumab pegol for maintenance of fistula closure.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of Crohn's disease

Exclusion Criteria:

Symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome.
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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Krassimir Mitchev, MD	UCB / Global Medical Affairs	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D003424	Crohn Disease
D005402	Fistula

Ancestor Terms

ID	Term
D015212	Inflammatory Bowel Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068582	Certolizumab Pegol

Ancestor Terms

ID	Term
D011092	Polyethylene Glycols
D011108	Polymers
D046911	Macromolecular Substances
D007140	Immunoglobulin Fab Fragments

Browse Leaves

Not provided

Browse Branches

Not provided