Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol

UCB

Status and phase: Completed; Phase 2

Conditions: Crohn's Disease

Treatments: Drug: certolizumab pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190410

CR0012

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatment in children and adolescents with moderately to severely active Crohn's disease.

Enrollment: 16 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject who completed the C87035 study (NCT00899678) through Week 62 or assessments when their participation in C87035 was terminated when the study was stopped by UBC
• Subject completed all assessments required for Week 62/Visit 23 at the time of termination
• Subjects maintain stable regimen of concomitant medications for Crohn's Disease (CD) throughout study

Exclusion criteria

• Subject who did not complete the C87035 study (Week 62 Visit), was terminated or did not complete all of the Week 62 assessments when their participation from C87035 was terminated when the study was stopped by UCB but did not complete all assessments required for Week 62/Visit 23 at the time of termination

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Certolizumab pegol: high-dose group

Experimental group

Description:

400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to \< 40 kg

Treatment:

Drug: certolizumab pegol

Drug: certolizumab pegol

Certolizumab pegol: low-dose group (weight adjusted)

Experimental group

Description:

200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to \< 40 kg

Treatment:

Drug: certolizumab pegol

Drug: certolizumab pegol