Phase 3
Completed N=539
Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
Source: ClinicalTrials.gov NCT00308581 ↗Enrolled (actual)
539
Serious AEs
9.9%
Results posted
Nov 2009
Primary outcomePrimary: Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase — 334; 205 participants
Summary
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Status With Response Defined as at Least 100 Point Decrease in Crohn's Disease Activity Score (CDAI Score) From Baseline in the Induction Phase |
334; 205 | — |
| SECONDARY Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase |
70; 66; 117; 120 | 0.696 |
| SECONDARY Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase |
373; 166 | — |
| SECONDARY Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase |
75; 75; 112; 111 | — |
| SECONDARY Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase |
212; 327 | — |
| SECONDARY Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase |
51; 52; 136; 134 | — |
| SECONDARY CDAI Score at Week 2 of the Induction Phase |
241.53 | — |
| SECONDARY CDAI Score at Week 4 of the Induction Phase |
220.87 | — |
| SECONDARY CDAI Score at Week 6 of the Induction Phase |
187.81 | — |
| SECONDARY CDAI Score at Week 8 in the Randomized Maintenance Phase |
175.62; 169.18 | — |
| SECONDARY CDAI Score at Week 10 in the Randomized Maintenance Phase |
164.65; 162.86 | — |
| SECONDARY CDAI Score at Week 12 in the Randomized Maintenance Phase |
173.83; 163.78 | — |
| SECONDARY CDAI Score at Week 14 in the Randomized Maintenance Phase |
162.34; 158.68 | — |
| SECONDARY CDAI Score at Week 16 in the Randomized Maintenance Phase |
163.73; 156.05 | — |
| SECONDARY CDAI Score at Week 18 in the Randomized Maintenance Phase |
153.38; 156.64 | — |
| SECONDARY CDAI Score at Week 20 in the Randomized Maintenance Phase |
162.79; 138.60 | — |
| SECONDARY CDAI Score at Week 22 in the Randomized Maintenance Phase |
128.13; 141.89 | — |
| SECONDARY CDAI Score at Week 24 in the Randomized Maintenance Phase |
135.49; 139.50 | — |
| SECONDARY CDAI Score at Week 26 in the Randomized Maintenance Phase |
122.37; 131.41 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 2 of the Induction Phase |
-66.57 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 4 of the Induction Phase |
-87.63 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 6 of the Induction Phase |
-120.33 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase |
-133.35; -137.70 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase |
-145.16; -145.26 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase |
-134.51; -145.17 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase |
-145.54; -144.08 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase |
-141.90; -144.89 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase |
-150.38; -144.66 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase |
-139.98; -162.85 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase |
-171.52; -159.13 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase |
-165.06; -160.44 | — |
| SECONDARY Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase |
-176.85; -168.59 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
2; 2 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
3; 4 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
3; 3 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
5; 8 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
7; 7 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
8; 6 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
8; 7 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
9; 5 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Remission at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
8; 5 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 10 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
2; 2 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 12 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
4; 4 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 14 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
5; 5 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 16 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
8; 10 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 18 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
9; 8 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 20 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
9; 7 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 22 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
9; 8 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 24 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
11; 5 | — |
| SECONDARY Number of Patients Able to Taper and Discontinue Steroids While Maintaining Response at Week 26 in the Randomized Maintenance Phase in the Subset of Patients Taking Steroids at Baseline. |
10; 6 | — |
| SECONDARY C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase |
9.5 | — |
| SECONDARY CRP Level at Week 2 of the Induction Phase |
4.2 | — |
| SECONDARY CRP Level at Week 4 of the Induction Phase |
3.8 | — |
| SECONDARY CRP Level at Week 6 of the Induction Phase |
4.2 | — |
| SECONDARY CRP Level at Week 8 in the Randomized Maintenance Phase |
5.6; 4.6 | — |
| SECONDARY CRP Level at Week 10 in the Randomized Maintenance Phase |
5.3 | — |
| SECONDARY CRP Level at Week 12 in the Randomized Maintenance Phase |
5.4; 3.7 | — |
| SECONDARY CRP Level at Week 14 in the Randomized Maintenance Phase |
0.6; 3.0 | — |
| SECONDARY CRP Level at Week 16 in the Randomized Maintenance Phase |
5.5; 4.4 | — |
| SECONDARY CRP Level at Week 18 in the Randomized Maintenance Phase |
18.4; 5.9 | — |
| SECONDARY CRP Level at Week 20 in the Randomized Maintenance Phase |
6.8; 4.4 | — |
| SECONDARY CRP Level at Week 22 in the Randomized Maintenance Phase |
13.0 | — |
| SECONDARY CRP Level at Week 24 in the Randomized Maintenance Phase |
5.2; 4.6 | — |
| SECONDARY CRP Level at Week 26 in the Randomized Maintenance Phase |
5.4; 5.1 | — |
| SECONDARY CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase |
6.9; 4.8 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with Crohn's Disease
- Previous treatment failure to Infliximab (intolerance and/or no response)
Exclusion Criteria
- Obstructive intestinal strictures
- Recent bowel resection
- Proctocolectomy or total colectomy
- Current total parenteral nutrition
- Short bowel syndrome
- All 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 (NCT00308581). 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.