Does Clinical Response Correlate With Serum Certolizumab Levels?

Phase 4

• Conditions: Crohn's Disease
• Interventions: Drug: Certolizumab Pegol

• Registration Number: NCT02597829
• Lead Sponsor: Shafran Gastroenterology Center

Brief Summary

A prospective open label trial of adult patients with active Crohn's disease to determine if plasma concentrations of certolizumab pegol correlate to mucosal healing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-27
• Status Verified: 2015-11
• Study Start: 2015-11
• Study First Submitted QC: 2015-11-04
• Last Update Submitted: 2015-11-04
• Study First Posted: 2015-11-05
• Last Update Posted: 2015-11-05
• Primary Completion: 2018-05
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Label Certolizumab Pegol	Certolizumab Pegol	Active Treatment

Primary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve endoscopic improvement.	20 Weeks

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve clinical response.	20 Weeks
Proportion of subjects who achieve clinical remission.	20 Weeks

Trial Locations

Locations (1)

Shafran Gastroenterology Center; 🇺🇸 Winter Park, Florida, United States