Phase 3
Completed N=89
Mucosal Healing Study in Crohn's Disease (CD)
Source: ClinicalTrials.gov NCT00297648 ↗Enrolled (actual)
89
Serious AEs
38.2%
Results posted
Jan 2010
Primary outcomePrimary: Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments — -6.47 score on a scale
Summary
The aim of the study will be to investigate the effect of certolizumab pegol on the intestinal mucosa in active Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Local Non-blinded Assessments |
-6.47 | — |
| PRIMARY Mean Change From Baseline in CDEIS (Crohn's Disease Endoscopic Index of Severity) Score at Week 10 Using Central Blinded Assessments |
-3.79 | — |
| SECONDARY Percentage of Patients Achieving Mucosal Healing at Week 10 Using Local Non-blinded Assessments |
5.1 | — |
| SECONDARY Percentage of Patients Achieving Mucosal Healing at Week 10 Using Central Blinded Assessments |
3.9 | — |
| SECONDARY Percentage of Patients Achieving Mucosal Healing at Week 54 Using Local Non-blinded Assessments |
13.2 | — |
| SECONDARY Percentage of Patients Achieving Mucosal Healing at Week 54 Using Central Blinded Assessments |
3.0 | — |
| SECONDARY Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Local Non-blinded Assessments |
61.5 | — |
| SECONDARY Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 10 Using Central Blinded Assessments |
38.6 | — |
| SECONDARY Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Local Non-blinded Assessments |
62.3 | — |
| SECONDARY Percentage of Patients With Endoscopic Response (Crohn's Disease Endoscopic Index of Severity (CDEIS) Decrease From Baseline of More Than 5 Points) at Week 54 Using Central Blinded Assessments |
39.3 | — |
| SECONDARY Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Local Non-blinded Assessments |
42.3 | — |
| SECONDARY Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 10 Using Central Blinded Assessments |
45.5 | — |
| SECONDARY Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Local Non-blinded Assessments |
28.3 | — |
| SECONDARY Percentage of Patients With Endoscopic Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 6) at Week 54 Using Central Blinded Assessments |
32.1 | — |
| SECONDARY Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Local Non-blinded Assessments |
11.5 | — |
| SECONDARY Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 10 Using Central Blinded Assessments |
20.5 | — |
| SECONDARY Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Local Non-blinded Assessments |
18.9 | — |
| SECONDARY Percentage of Patients With Endoscopic Complete Remission (Crohn's Disease Endoscopic Index of Severity (CDEIS) Score Below 3) at Week 54 Using Central Blinded Assessments |
17.9 | — |
| SECONDARY Change From Baseline in Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment |
-1.4 | — |
| SECONDARY Change From Baseline in Histological Crohn's Disease Score at Week 54 Using Central Blinded Assessment |
-2.5 | — |
| SECONDARY Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 10 |
50.6 | — |
| SECONDARY Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Response (Defined as a Decrease of at Least 100 Points in CDAI Score From Baseline) at Week 54 |
32.6 | — |
| SECONDARY Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 10 |
46.1 | — |
| SECONDARY Percentage of Patients Achieving Crohn's Disease Activity Index (CDAI) Remission (Defined as a CDAI Score Less Than or Equal to 150) at Week 54 |
27.0 | — |
| SECONDARY Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 10 |
6.84 | — |
| SECONDARY Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 10 |
0.40 | — |
| SECONDARY Geometric Mean C-Reactive Protein (CRP) Level (mg/L) at Week 52 |
10.24 | — |
| SECONDARY Ratio to Baseline of C-Reactive Protein (CRP) Level (mg/L) at Week 52 |
0.52 | — |
| SECONDARY Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Activity Index (CDAI) Score at Week 10 |
0.043 | — |
| SECONDARY Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Local Non-blinded Assessment |
0.131 | — |
| SECONDARY Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 10 Using Central Blinded Assessment |
0.646 | — |
| SECONDARY Correlation Between Mean C-Reactive Protein (CRP) Plasma Level and Histological Crohn's Disease Score at Week 10 Using Central Blinded Assessment |
0.086 | — |
| SECONDARY Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Local Non-blinded Assessment |
-5.49 | — |
| SECONDARY Change From Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score at Week 54 Using Central Blinded Assessment |
-2.95 | — |
| SECONDARY Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 10 |
-148.82 | — |
| SECONDARY Change From Baseline in Crohn's Disease Activity Index (CDAI) Score at Week 54 |
-169.59 | — |
Eligibility Criteria
Inclusion Criteria
- Patients suffering from active Crohn's disease [Crohn's Disease Activity Index(CDAI) ≥ 220 and ≤ 450] and at least 2 segments with endoscopic ulcerative lesions with Baseline Crohn's Disease Endoscopic Index of Severity (CDEIS) ≥ 8
- Patients who need to be treated by anti-tumor necrosis factor (anti-TNF) therapy
Exclusion Criteria
- Obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, current total parenteral nutrition, short bowel syndrome
- History of tuberculosis or positive tests for tuberculosis at screening
- All the concomitant diseases or pathological conditions that could interfere with Crohn's disease assessment or to be harmful for the well being of the patient
- Previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial
Data sourced from ClinicalTrials.gov (NCT00297648). 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.