Clinical trial · Interventional
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
Open Label Long Term Clinical Trial Evaluating Efficacy and Safety of Chronic Therapy With Certolizumab Pegol, a PEGylated Fab Fragment of Humanized Antibody to Tumor Necrosis Factor Alpha (TNF) in Patients Suffering From Crohn's Disease and Having Completed C87042 Study.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will continue to assess the safety of certolizumab pegol (CDP870) as well as examine the evolution of long term efficacy in Crohn's disease patients who completed study C87042 \[NCT00308581\]. It will also assess the effect of subcutaneous CDP870 400 mg on direct cost parameters.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Crohn's Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Certolizumab pegol (CDP870) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Certolizumab pegol 400 mg
- description
- 400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
- interventionNames
- Biological: Certolizumab pegol (CDP870)
Primary outcomes (1)
- measure
- Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks)
- timeFrame
- Maximum 164 weeks
- description
- Study-emergent adverse events are defined as treatment-emergent adverse events with an onset date on or after the first study drug administration date of this study but not later than 12 weeks (84 days) after last injection. Results are presented as the percentage of subjects with at least one treatment-emergent adverse event during this study.
Secondary outcomes (23)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients having completed study C87042 \[NCT00308581\] (previously treated with infliximab) Exclusion Criteria: * Subject withdraw from C87042 \[NCT00308581\] study * Subject who received treatment other than certolizumab pegol and other than medications permitted in C87042 \[NCT00308581\] study * Subjects from countries where certolizumab pegol is authorized in Crohn's disease treatment * Female patients of childbearing age who are NOT practicing (in the Investigator's opinion) effective birth control. All female patients must test negative on a serum pregnancy test before study entry and negative on urine testing immediately before every certolizumab pegol administration
References
Publications (0)
Data not yet available