| June 30, 2006 |
| July 30, 2009 |
| September 2006 |
| July 2009 (final data collection date for primary outcome measure) |
| Compare certolizumab pegol and placebo treatments in patients successfully withdrawn from prednisone or prednisolone: tapering schedule of the protocol, remained off corticosteroids, in disease remission (CDAI≤150 at week 36 of treatment. [ Time Frame: duration of trial ] [ Designated as safety issue: No ] |
| Compare certolizumab pegol and placebo treatments in patients who have been successfully withdrawn from prednisone or prednisolone. |
| Complete list of historical versions of study NCT00349752 on ClinicalTrials.gov Archive Site |
- Proportion of patients with continuous remission [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
- Proportion of patients with relapse [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
- Time to relapse [ Time Frame: duration of trial ] [ Designated as safety issue: No ]
- Corticosteroids use over the duration of the study [ Time Frame: duration of the trial ] [ Designated as safety issue: No ]
- Safety [ Time Frame: duration of the trial ] [ Designated as safety issue: No ]
|
| Proportion of patients with continuous remission, Proportion of patients with relapse; Time to relapse; Corticosteroids use; Safety. |
| |
| Corticosteroid Sparing Effect of Certolizumab |
| A Phase IIIb Multicenter, Double-blind, Placebo-controlled,Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Patients With Moderate to Severe Crohn's Disease. |
The current study is designed to measure the corticosteroid-sparing effect of certolizumab pegol using a defined schedule of corticosteroid tapering in patients with moderate to severe Crohn's disease. |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Crohn's Disease |
- Biological: certolizumab pegol
- Other: Placebo
|
| Experimental: Certolizumab pegol |
| |
| |
| Completed |
| 174 |
| July 2009 |
| July 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Men and women
- Age 18 years or older with moderate to severe Crohn's disease (CDAI score of ≥ 220 ≤450).
Exclusion Criteria:
- Active or draining fistula present at screening.
- Lactating and/or pregnant female patients.
- A history of any health condition that could potentially interfere with the disease and/or the treatment.
- A history of an adverse reaction to polyethylene glycol (PEG) or a protein medicinal product.
- Any other condition which in the Investigator's judgment would make the patient unsuitable for inclusion in the study.
- History of drug or alcohol abuse in the prior year.
- Receipt of any experimental therapy within or outside a clinical trial in the 3 months prior to Visit 0.
|
| Both |
| 18 Years and older |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States, Canada, Germany |
| |
| NCT00349752 |
| Study Director, UCB |
| C87059, CDP870/C87059, COSPAR I |
| UCB, Inc. |
|
| Study Director: |
UCB Clinical Trial Call Center |
+1 877 822 9493 (UCB) |
|
|
| UCB, Inc. |
| July 2009 |
