Phase 3
Completed N=233
Follow-up to Welcome Study C87042 [NCT00308581] Examining Certolizumab Pegol (CDP870) in Subjects With Crohn's Disease
Source: ClinicalTrials.gov NCT00333788 ↗Enrolled (actual)
233
Serious AEs
31.9%
Results posted
Jul 2011
Primary outcomePrimary: Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) — 92.6 percentage of participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of at Least One Study-emergent Adverse Event During the Study (Maximum 164 Weeks) |
92.6 | — |
| SECONDARY Maintenance of Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] Among the Subjects in Clinical Response at Baseline of This Study (Week 26 of Study C87042). |
61.8 | — |
| SECONDARY Clinical Response at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
53.3 | — |
| SECONDARY Remission at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
40.6 | — |
| SECONDARY Change From Baseline of Study C87042 (NCT00308581) in Crohn's Disease Activity Index (CDAI) at Last Visit [Up to the Maximum Study Duration Observed in the Study (Week 154) or the Withdrawal Visit for Premature Withdrawals] |
-121.52 | — |
| SECONDARY Time to Loss of Response After Baseline of Study C87042 (NCT00308581) on Subjects Who Were in Clinical Response at Baseline of This Study |
169.5 | — |
| SECONDARY Occurrence of at Least 1 Hospital Stay During the Treatment Period |
21.4 | — |
| SECONDARY Occurrence of at Least 1 Hospital Stay During the Follow-Up Period |
21.8 | — |
| SECONDARY Occurrence of at Least 1 Hospital Stay During the During the Overall Period |
37.6 | — |
| SECONDARY Length of Hospital Stays During the Treatment Period |
1.838 | — |
| SECONDARY Length of Hospital Stays During the Follow-Up Period |
2.782 | — |
| SECONDARY Length of Hospital Stays During the Overall Period |
4.620 | — |
| SECONDARY Occurrence of at Least 1 Emergency Room Visit During the Treatment Period |
13.1 | — |
| SECONDARY Occurrence of at Least 1 Emergency Room Visit During the Follow-Up Period |
6.1 | — |
| SECONDARY Occurrence of at Least 1 Emergency Room Visit During the Overall Period |
19.2 | — |
| SECONDARY Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Treatment Period |
0.4; 3.9; 24.0; 5.2; 55.5 | — |
| SECONDARY Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Follow-Up Period |
16.2; 5.2; 15.3; 2.2; 14.0 | — |
| SECONDARY Occurrence of at Least One Concomitant Medication Potentially Influencing Crohn's Disease During the Overall Period |
16.2; 8.3; 35.4; 7.0; 62.4 | — |
| SECONDARY Occurrence of at Least 1 General Concomitant Medication During the Treatment Period |
185 | — |
| SECONDARY Occurrence of at Least 1 General Concomitant Medication During the Follow-Up Period |
71 | — |
| SECONDARY Occurrence of at Least 1 General Concomitant Medication During the Overall Period |
195 | — |
| SECONDARY Occurrence of at Least 1 Concurrent Medical Procedure During the Treatment Period. |
148 | — |
| SECONDARY Occurrence of at Least 1 Concurrent Medical Procedure During the Follow-Up Period |
84 | — |
| SECONDARY Occurrence of at Least 1 Concurrent Medical Procedure During the Overall Period |
173 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00333788). 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.