Maintenance Study of Certolizumab Pegol (CZP) in Crohn's Disease

Phase 2

Completed

Conditions: Crohn's Disease

Interventions: Biological: Certolizumab pegol (CZP)

Registration Number: NCT00329550

Lead Sponsor: UCB Japan Co. Ltd.

Brief Summary: This is a multi-centre, open-label extension study in subjects who showed clinical response to induction therapy in the treatment of subjects with active Crohn's disease in the double-blind main study C87037 (NCT00291668).

Detailed Description: In the double-blind main study subjects were dosed at Weeks 0, 2 and 4, with the primary outcome, clinical response, being assessed at Week 6. Subjects who showed clinical response at Week 6 were eligible to enter this open-label extension study. The first visit in this extension study was 2 weeks after Week 6, i.e., Week 8. Subjects in this extension study were dosed at Weeks 8, 12, 16, 20 and 24, with the primary outcome, clinical response, being assessed at Week 26. All week numbers quoted are relative to the start of the double-blind main study.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 40

Inclusion Criteria

Subjects who participated in main double-blind induction study C87037 (NCT00291668) and showed clinical efficacy

Exclusion Criteria

Subjects who experienced aggravation of Crohn's disease during main double-blind induction study C87037 (NCT00291668) and required treatment change

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CZP 400 mg / CZP 400 mg	Certolizumab pegol (CZP)	Certolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 400 mg in double-blind main study (NCT00291668)
CZP 400 mg / Placebo	Certolizumab pegol (CZP)	Certolizumab pegol (CZP) 400 mg in this extension study / Placebo in double-blind main study (NCT00291668)
CZP 400 mg / CZP 200 mg	Certolizumab pegol (CZP)	Certolizumab pegol (CZP) 400 mg in this extension study / Certolizumab pegol (CZP) 200 mg in double-blind main study (NCT00291668)

Primary Outcome Measures

Name	Time	Method
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.

Secondary Outcome Measures

Name	Time	Method
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 16	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 8	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Percentage of Subjects Achieving Remission at Week 20	Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 24	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 12	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Percentage of Subjects Achieving Remission at Week 16	Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Percentage of Subjects Achieving Remission at Week 8	Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 12	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 26	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 16	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 20	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 24	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	CDAI responders are subjects achieving either clinical response (a reduction in CDAI score of ≥100 points from Week 0), or remission (CDAI ≤150). CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 8	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Week 20	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Change From Week 0 in Crohn's Disease Activity Index (CDAI) Score at Last Visit [Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals]	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Time to Disease Progression	Week 6 to Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 6' is the last visit in the double-blind main study and 'Week 26' is 18 weeks after the first visit in this extension study.	Time to disease progression is defined as the earliest of: * time to an increase from Week 6 of ≥100 points in Crohn's Disease Activity Index (CDAI) score and CDAI \>175 points for at least 2 consecutive visits, * time to use of rescue therapy, or, * time to subject withdrawal from the study.
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	The Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Percentage of Subjects Achieving Remission at Week 12	Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Percentage of Subjects Achieving Remission at Week 26	Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
C-Reactive Protein (CRP) Level at Week 24	Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Percentage of Subjects Achieving Remission at Week 24	Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Percentage of Subjects Achieving Remission at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)	Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	The Crohn's Disease Activity Index (CDAI) is used to quantify the symptoms of subjects with Crohn's disease. A CDAI score of 150 or below indicates remission and a score above 450 indicates extremely severe disease.
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Global Score	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	The IBDQ Global Score is the sum of 32 responses, each ranging from 0 to 7, thus the Global Score ranges from 0 to 224; a higher score indicating a better quality of life.
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	The Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	The Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	The Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
C-Reactive Protein (CRP) Level at Week 26	Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 8 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 24 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Ratio of C-Reactive Protein (CRP) Level at Week 16 to Week 0	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Domain Sub-Score	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	The IBDQ Bowel Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 16 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Systemic Domain Sub-Score	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	The IBDQ Systemic Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 12 in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	The IBDQ Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) in Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	The Inflammatory Bowel Disease Questionnaire (IBDQ) Emotional Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 20 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
Change From Week 0 to Week 26 in Inflammatory Bowel Disease Questionnaire (IBDQ) Social Domain Sub-Score	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	The IBDQ Social Domain Sub-Score is the sum of 8 responses, each ranging from 0 to 7, thus the Sub-Score ranges from 0 to 56; a higher score indicating a better quality of life.
C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals)	Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
C-Reactive Protein (CRP) Level at Week 20	Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Percentage of Subjects at Week 20 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
C-Reactive Protein (CRP) Level at Week 8	Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
C-Reactive Protein (CRP) Level at Week 12	Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
C-Reactive Protein (CRP) Level at Week 16	Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.
Ratio of C-Reactive Protein (CRP) Level at Week 12 to Week 0	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.
Percentage of Subjects at Week 24 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects at Week 26 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
C-Reactive Protein (CRP) Level at Week 0	Week 0 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 0' is the Baseline visit in the double-blind main study.
Ratio of C-Reactive Protein (CRP) Level at Week 8 to Week 0	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.
Percentage of Subjects at Week 12 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0	Week 0 and Week 12 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 12' is 4 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Ratio of C-Reactive Protein (CRP) Level at Week 20 to Week 0	Week 0 and Week 20 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 20' is 12 weeks after the first visit in this extension study.
Ratio of C-Reactive Protein (CRP) Level at Week 24 to Week 0	Week 0 and Week 24 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 24' is 16 weeks after the first visit in this extension study.
Ratio of C-Reactive Protein (CRP) Level at Week 26 to Week 0	Week 0 and Week 26 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 26' is 18 weeks after the first visit in this extension study.
Ratio of C-Reactive Protein (CRP) Level at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) to Week 0	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.
Percentage of Subjects at Week 8 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0	Week 0 and Week 8 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 8' is the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects at Week 16 Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0	Week 0 and Week 16 (relative to the start of the 6-week double-blind main study (NCT00291668)). 'Week 16' is 8 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Percentage of Subjects at Last Visit (Week 26 for Completers or the Withdrawal Visit for Premature Withdrawals) Achieving a Reduction in Crohn's Disease Activity Index (CDAI) Score of ≥70 Points From Week 0	Week 0 and Last Visit (Week 26 relative to the start of the 6-week double-blind main study (NCT00291668) for completers or the Withdrawal Visit for premature withdrawals). 'Week 26' is 18 weeks after the first visit in this extension study.	CDAI is used to quantify the symptoms of subjects with Crohn's disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.