CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 16 enrolled
Drug / intervention
certolizumab pegol +1 moredrug
Likely dose
certolizumab pegol 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01190410
NCT01190410Phase 2Completed
CompareCT.gov

An Open-label, Multicenter Study to Assess the Safety of Certolizumab Pegol in Children and Adolescents With Active Crohn's Disease Who Completed C87035 (NCT00899678) or Who Were Terminated From C87035

UCB Pharma·interventional·Posted Aug 27, 2010·Updated Dec 17, 2020

In Brief

A Phase 2 clinical trial evaluating certolizumab pegol for Crohn's Disease. Completed, enrolled 16 participants across 10 sites in 3 countries.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustralia, Canada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 27, 2010
Enrollment StartAug 1, 2010
Primary CompletionNov 27, 2017
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 15.8 years ago

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