Phase 2
Completed N=16
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
Source: ClinicalTrials.gov NCT01190410 ↗Enrolled (actual)
16
Serious AEs
31.3%
Results posted
Mar 2019
Primary outcomePrimary: Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) — 2; 6; 2 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) |
2; 6; 2 | — |
| SECONDARY Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE) |
0; 2; 0 | — |
| SECONDARY Number of Subjects Who Develop Anti-nuclear Antibodies During the Study |
0; 3 | — |
| SECONDARY Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study |
0; 0 | — |
| SECONDARY Percentage of Subjects in Clinical Remission |
100; 44.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01190410). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.