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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01190410
• Date of registration: 25/08/2010
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
• Scientific title: 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
• Date of first enrolment: August 2010
• Target sample size: 16
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01190410
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Australia, Canada, United States

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: [phone] UCB

Key inclusion & exclusion 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



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: certolizumab pegol

Primary Outcome(s)

Number of Subjects Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During Study Treatment (up to 303 Weeks) [Time Frame: During study treatment (up to 303 weeks)]

Secondary Outcome(s)

Number of Subjects Who Develop Double-stranded Deoxyribonucleic Acid (dsDNA) Antibodies During the Study [Time Frame: At the time of completion or termination visit (up to 298 weeks)]

Number of Subjects Discontinuing Treatment Due to a Treatment-Emergent Adverse Event (TEAE) [Time Frame: During study treatment (up to 303 weeks)]

Number of Subjects Who Develop Anti-nuclear Antibodies During the Study [Time Frame: At the time of completion or termination visit (up to 298 weeks)]

Percentage of Subjects in Clinical Remission [Time Frame: At the time of completion or termination visit (up to 298 weeks)]

Secondary ID(s)

CR0012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/03/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01190410