Recruiting

Certolizumab Pegol

Sponsor:

Atlanta Gastroenterology Associates

Code:

NCT01024647

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

certolizumab pegol

certolizumab pegol

certolizumab pegol

certolizumab pegol

Study Details

Brief summary:

The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.

Conditions

Crohn's Disease

Study ID

NCT01024647

Start date

Dec, 2009

Status verified date

Nov, 2012

Completion date

May, 2013

Anticipated

Primary completion date

May, 2013

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • ileal and/or colonic Crohn's disease
  • moderate to severe Crohn's disease

Exclusion Criteria:

  • short bowel syndrome
  • ostomy
  • anti-TNF therapy within 4 weeks
  • prior certolizumab therapy

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Loss of Reponse Reinduction Responders

Loss of Response Reinduction Responders:certolizumab pegol (Cimzia) 200 mg every 2 weeks

active comparator: Response loss Reinduction Non-Responders

Response Loss Reinduction Non-Responders:certolizumab pegol(Cimzia) 400 mg every 2 weeks

active comparator: Responders

Responders: certolizumab pegol(Cimzia) 400 mg every 4 weeks

active comparator: Non-Responders

Non-Responders: certolizumab pegol (Cimzia) 400 mg every 2 weeks

Interventions

certolizumab pegol

certolizumab pegol 200 mg every 2 weeks

certolizumab pegol

certolizumab pegol 400 mg every 2 weeks

certolizumab pegol

certolizumab pegol 400 mg every 4 weeks

certolizumab pegol

certolizumab pegol 400 mg every 2 weeks

Primary outcome measure

  • Crohn's Disease Activity Index [ Time Frame: 26 Weeks, if responder up to 52 weeks ]

Central Contacts and Locations

Central contacts

Lamia S Mereby, BSN

404-257-9000lamia.mereby@atlantagastro.com

Ashleigh K Arnold, BS

404-257-9000ashleigh.kapperman@atlantagastro.com

Locations

Atlanta Gastroenterology Associates

Recruiting

Atlanta, Georgia, United States, 30342

Contacts

Lamia S Mereby, BSN

404-257-9000lamia.mereby@atlantagastro.com

More Information

Sponsor

Atlanta Gastroenterology Associates

Last update posted

Nov 4, 2012

Last verified

Nov, 2012

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atlanta Gastroenterology Associates on 2012-11-04.