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

Phase 2CompletedNCT01190410

UCB Pharma16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn's Disease

Interventions

certolizumab pegolDRUG

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

certolizumab pegolDRUG

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

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (10)

114

Orange, California, United States

111

Aurora, Colorado, United States

103

Atlanta, Georgia, United States

116

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks)

Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

Time frame: During study treatment (up to 303 weeks)

Secondary Outcomes

Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE)

Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.

Time frame: During study treatment (up to 303 weeks)

Number of Subjects Who Develop Anti-nuclear Antibodies During the Study

Anti-nuclear antibodies (ANA) are autoantibodies. ANA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.

Time frame: At the time of completion or termination visit (up to 298 weeks)

Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study

Anti-dsDNA are autoantibodies. Anti-dsDNA titers will be determined every 12 weeks starting at Week 14, and at the Completion/Early Termination and Safety Follow-Up (SFU) Visits.

Time frame: At the time of completion or termination visit (up to 298 weeks)

Percentage of Subjects in Clinical Remission

Percentage of subjects in clinical remission (clinical remission is defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score ≤ 10)

Time frame: At the time of completion or termination visit (up to 298 weeks)

Data from ClinicalTrials.gov

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