Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A Randomized Trial to Examine the Corticosteroid-sparing Effect of Certolizumab Pegol in Subjects With Moderate to Severe Crohn's Disease from November 2006 to July 2009

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Certolizumab Pegol 400 mg	Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
Placebo	Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36

Participant Flow:   Overall Study

	Certolizumab Pegol 400 mg	Placebo
STARTED	87	87
COMPLETED	28	23
NOT COMPLETED	59	64
Adverse Event	8	12
Lack of Efficacy	37	42
Lost to Follow-up	4	2
Personal reasons	6	5
Other: Required exclusionary medication	0	1
Other: Non compliance	0	1
Other: Patient stopped steroids	0	1
Other: Patient's steroid use	1	0
Other: Ineligible	1	0
Other: Inadvertently unblinded	1	0
Other:History of squamous cell carcinoma	1	0

Reporting Groups

	Description
Certolizumab Pegol 400 mg	Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
Placebo	Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36

Baseline Measures

	Certolizumab Pegol 400 mg	Placebo	Total
Number of Participants   [units: participants]	87	87	174
Age   [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	85	85	170
>=65 years	2	2	4
Age   [units: years] Mean ± Standard Deviation	40.77  ± 13.20	39.73  ± 13.31	40.25  ± 13.23
Gender   [units: participants]
Female	52	45	97
Male	35	42	77
Region of Enrollment   [units: participants]
United States	65	68	133
Canada	18	11	29
Germany	4	8	12

1.  Primary:

Percentage of Subjects Who Have Been Withdrawn From Prednisone or Prednisolone Therapy According to the Corticosteroid Tapering Schedule and Have Remained Off Corticosteroids and in Disease Remission at Week 38   [ Time Frame: Week 38 ]

2.  Secondary:

Percentage of Subjects With Continuous Remission Off Steroids at Week 38   [ Time Frame: Week 38 ]

3.  Secondary:

Cumulative Percentage of Subjects With Relapse/Treatment Failure at Week 38   [ Time Frame: Week 38 ]

4.  Secondary:

Time to Relapse/Treatment Failure During the 38-week Double-blind Treatment Period   [ Time Frame: During the 38-week double-blind treatment period ]

5.  Secondary:

Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period   [ Time Frame: Over the 38-week double-blind treatment period ]

6.  Secondary:

Per-subject Cumulative Dose of Corticosteroids Over the 48-week Study Period   [ Time Frame: Over the 48-week study period ]

7.  Secondary:

Change From the 6-week run-in Period in Per-subject Median Weekly Dose of Corticosteroids Over the 38-week Double-blind Treatment Period   [ Time Frame: 6-week run-in period, 38-week double-blind treatment period ]

8.  Secondary:

Crohn's Disease Activity Index (CDAI) Score at Week 38   [ Time Frame: Week 38 ]

9.  Secondary:

Change From Baseline in CDAI Score at Week 38   [ Time Frame: Week 0, Week 38 ]

10.  Secondary:

Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38   [ Time Frame: Week 38 ]

11.  Secondary:

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 38   [ Time Frame: Week 0, Week 38 ]