Crohn's Disease
Conditions
Keywords
Crohn's Disease, Certolizumab pegol
Brief 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
Interventions
BIOLOGICALCertolizumab pegol
400mg Certolizumab Pegol, Q4W, administered 4-weekly
OTHERPlacebo
placebo administered 4-weekly in Active 1
Sponsors
UCB Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline to Week 6 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase | Baseline to Week 26 | Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score 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. |
| Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase | Baseline to Week 6 | Response is defined as at least 70 points reduction in CDAI score. The CDAI score 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. |
| Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase | Baseline to Week 26 | Response is defined as at least 70 points reduction in CDAI score. The CDAI score 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. |
| Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase | Week 6 | Remission is defined as CDAI score ≤ 150. The CDAI score 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. |
| Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase | Week 26 | Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms 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. |
| CDAI Score at Week 2 of the Induction Phase | Week 2 | The CDAI score 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. |
| CDAI Score at Week 4 of the Induction Phase | Week 4 | The CDAI score 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. |
| CDAI Score at Week 6 of the Induction Phase | Week 6 | The CDAI score 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. |
| CDAI Score at Week 8 in the Randomized Maintenance Phase | Week 8 | The CDAI score 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. |
| CDAI Score at Week 10 in the Randomized Maintenance Phase | Week 10 | The CDAI score 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. |
| CDAI Score at Week 12 in the Randomized Maintenance Phase | Week 12 | The CDAI score 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. |
| CDAI Score at Week 14 in the Randomized Maintenance Phase | Week 14 | The CDAI score 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. |
| CDAI Score at Week 16 in the Randomized Maintenance Phase | Week 16 | The CDAI score 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. |
| CDAI Score at Week 18 in the Randomized Maintenance Phase | Week 18 | The CDAI score 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. |
| CDAI Score at Week 20 in the Randomized Maintenance Phase | Week 20 | The CDAI score 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. |
| CDAI Score at Week 22 in the Randomized Maintenance Phase | Week 22 | The CDAI score 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. |
| CDAI Score at Week 24 in the Randomized Maintenance Phase | Week 24 | The CDAI score 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. |
| CDAI Score at Week 26 in the Randomized Maintenance Phase | Week 26 | The CDAI score 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 Baseline in CDAI Score at Week 2 of the Induction Phase | Baseline to Week 2 | The CDAI score 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 Baseline in CDAI Score at Week 4 of the Induction Phase | Baseline to Week 4 | The CDAI score 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 Baseline in CDAI Score at Week 6 of the Induction Phase | Baseline to Week 6 | The CDAI score 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 Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase | Baseline to Week 8 | The CDAI score 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 Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase | Baseline to Week 10 | The CDAI score 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 Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase | Baseline to Week 12 | The CDAI score 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 Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase | Baseline to Week 14 | The CDAI score 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 Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase | Baseline to Week 16 | The CDAI score 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 Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase | Baseline to Week 18 | The CDAI score 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 Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase | Baseline to Week 20 | The CDAI score 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 Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase | Baseline to Week 22 | The CDAI score 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 Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase | Baseline to Week 24 | The CDAI score 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 Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase | Baseline to Week 26 | The CDAI score 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. |
| 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. | Week 10 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 12 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 14 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 16 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 18 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 20 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 22 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 24 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 26 | Remission is defined as CDAI score ≤ 150. |
| 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. | Week 10 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| 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. | Week 12 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| 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. | Week 14 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| 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. | Week 16 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| 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. | Week 18 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| 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. | Week 20 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| 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. | Week 22 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| 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. | Week 24 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| 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. | Week 26 | Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score). |
| C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase | Week 0 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 2 of the Induction Phase | Week 2 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 4 of the Induction Phase | Week 4 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 6 of the Induction Phase | Week 6 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 8 in the Randomized Maintenance Phase | Week 8 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 10 in the Randomized Maintenance Phase | Week 10 (optional measurement) | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 12 in the Randomized Maintenance Phase | Week 12 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 16 in the Randomized Maintenance Phase | Week 16 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 18 in the Randomized Maintenance Phase | Week 18 (optional measurement) | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 20 in the Randomized Maintenance Phase | Week 20 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 22 in the Randomized Maintenance Phase | Week 22 (optional measurement) | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 24 in the Randomized Maintenance Phase | Week 24 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Week 26 in the Randomized Maintenance Phase | Week 26 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
| CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase | Last visit on or before Week 26 | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout. |
| CRP Level at Week 14 in the Randomized Maintenance Phase | Week 14 (optional measurement) | High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6 | Week 6 to Week 26 | Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score \> 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits. |
Countries
Austria, Belgium, Canada, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden, Switzerland, United Kingdom, United States
Participant flow
Pre-assignment details
Of the 539 subjects that have been enrolled in the induction phase, 373 have been included in the randomized maintenance phase. The Baseline Characteristics module only includes the Intent-to-treat (ITTI) population of the induction phase.
Participants by arm
| Arm | Count |
|---|---|
| Overall Overall Induction | 539 |
| Total | 539 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Induction Phase | Adverse Event | 0 | 0 | 37 |
| Induction Phase | Lack of Efficacy | 0 | 0 | 121 |
| Induction Phase | Unknown reason | 0 | 0 | 3 |
| Induction Phase | Withdrawal by Subject | 0 | 0 | 5 |
| Randomized Maintenance Phase | Adverse Event | 10 | 17 | 0 |
| Randomized Maintenance Phase | Lack of Efficacy | 9 | 21 | 0 |
| Randomized Maintenance Phase | Lost to Follow-up | 0 | 2 | 0 |
| Randomized Maintenance Phase | Switched to Q2W open-label treatment | 82 | 59 | 0 |
| Randomized Maintenance Phase | Unknown reason | 3 | 0 | 0 |
| Randomized Maintenance Phase | Withdrawal by Subject | 1 | 4 | 0 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 13 Participants |
| Age, Categorical Between 18 and 65 years | 526 Participants |
| Age, Continuous | 37.67 years STANDARD_DEVIATION 12.19 |
| Region of Enrollment Austria | 16 participants |
| Region of Enrollment Belgium | 88 participants |
| Region of Enrollment Canada | 43 participants |
| Region of Enrollment Denmark | 11 participants |
| Region of Enrollment France | 45 participants |
| Region of Enrollment Germany | 64 participants |
| Region of Enrollment Italy | 53 participants |
| Region of Enrollment Netherlands | 17 participants |
| Region of Enrollment Norway | 9 participants |
| Region of Enrollment Spain | 11 participants |
| Region of Enrollment Sweden | 4 participants |
| Region of Enrollment Switzerland | 8 participants |
| Region of Enrollment United Kingdom | 29 participants |
| Region of Enrollment United States | 141 participants |
| Sex: Female, Male Female | 345 Participants |
| Sex: Female, Male Male | 194 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 97 / 187 | 106 / 186 | 277 / 539 |
| serious Total, serious adverse events | 25 / 187 | 25 / 186 | 40 / 539 |
Outcome results
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
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score 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 frame: Baseline to Week 6
Population: Intent-to-treat Induction Phase (ITTI) population: subjects who received at least one dose of study drug in the induction phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | 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 | Response | 334 participants |
| Overall | 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 | Non-Response | 205 participants |
Secondary
CDAI Score at Week 10 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 10
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 10 in the Randomized Maintenance Phase | 164.65 points on a scale | Standard Deviation 98.16 |
| Q2W Regimen | CDAI Score at Week 10 in the Randomized Maintenance Phase | 162.86 points on a scale | Standard Deviation 88.66 |
Secondary
CDAI Score at Week 12 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 12
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 12 in the Randomized Maintenance Phase | 173.83 points on a scale | Standard Deviation 103.89 |
| Q2W Regimen | CDAI Score at Week 12 in the Randomized Maintenance Phase | 163.78 points on a scale | Standard Deviation 96.19 |
Secondary
CDAI Score at Week 14 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 14
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 14 in the Randomized Maintenance Phase | 162.34 points on a scale | Standard Deviation 99.74 |
| Q2W Regimen | CDAI Score at Week 14 in the Randomized Maintenance Phase | 158.68 points on a scale | Standard Deviation 90.76 |
Secondary
CDAI Score at Week 16 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 16
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 16 in the Randomized Maintenance Phase | 163.73 points on a scale | Standard Deviation 103.65 |
| Q2W Regimen | CDAI Score at Week 16 in the Randomized Maintenance Phase | 156.05 points on a scale | Standard Deviation 90.49 |
Secondary
CDAI Score at Week 18 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 18
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 18 in the Randomized Maintenance Phase | 153.38 points on a scale | Standard Deviation 95.65 |
| Q2W Regimen | CDAI Score at Week 18 in the Randomized Maintenance Phase | 156.64 points on a scale | Standard Deviation 90.99 |
Secondary
CDAI Score at Week 20 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 20
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 20 in the Randomized Maintenance Phase | 162.79 points on a scale | Standard Deviation 112.53 |
| Q2W Regimen | CDAI Score at Week 20 in the Randomized Maintenance Phase | 138.60 points on a scale | Standard Deviation 80.78 |
Secondary
CDAI Score at Week 22 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 22
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 22 in the Randomized Maintenance Phase | 128.13 points on a scale | Standard Deviation 85.34 |
| Q2W Regimen | CDAI Score at Week 22 in the Randomized Maintenance Phase | 141.89 points on a scale | Standard Deviation 90.43 |
Secondary
CDAI Score at Week 24 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 24
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 24 in the Randomized Maintenance Phase | 135.49 points on a scale | Standard Deviation 99.92 |
| Q2W Regimen | CDAI Score at Week 24 in the Randomized Maintenance Phase | 139.50 points on a scale | Standard Deviation 75.98 |
Secondary
CDAI Score at Week 26 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 26
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 26 in the Randomized Maintenance Phase | 122.37 points on a scale | Standard Deviation 87.49 |
| Q2W Regimen | CDAI Score at Week 26 in the Randomized Maintenance Phase | 131.41 points on a scale | Standard Deviation 79.52 |
Secondary
CDAI Score at Week 2 of the Induction Phase
The CDAI score 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 frame: Week 2
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 2 of the Induction Phase | 241.53 points on a scale | Standard Deviation 97.03 |
Secondary
CDAI Score at Week 4 of the Induction Phase
The CDAI score 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 frame: Week 4
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 4 of the Induction Phase | 220.87 points on a scale | Standard Deviation 101.05 |
Secondary
CDAI Score at Week 6 of the Induction Phase
The CDAI score 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 frame: Week 6
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 6 of the Induction Phase | 187.81 points on a scale | Standard Deviation 103.34 |
Secondary
CDAI Score at Week 8 in the Randomized Maintenance Phase
The CDAI score 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 frame: Week 8
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | CDAI Score at Week 8 in the Randomized Maintenance Phase | 175.62 points on a scale | Standard Deviation 94.08 |
| Q2W Regimen | CDAI Score at Week 8 in the Randomized Maintenance Phase | 169.18 points on a scale | Standard Deviation 86.63 |
Secondary
Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 10
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase | -145.16 points on a scale | Standard Deviation 90.76 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 10 in the Randomized Maintenance Phase | -145.26 points on a scale | Standard Deviation 76.97 |
Secondary
Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 12
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase | -134.51 points on a scale | Standard Deviation 91.52 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 12 in the Randomized Maintenance Phase | -145.17 points on a scale | Standard Deviation 78.88 |
Secondary
Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 14
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase | -145.54 points on a scale | Standard Deviation 86.85 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 14 in the Randomized Maintenance Phase | -144.08 points on a scale | Standard Deviation 86.34 |
Secondary
Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 16
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase | -141.90 points on a scale | Standard Deviation 98.56 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 16 in the Randomized Maintenance Phase | -144.89 points on a scale | Standard Deviation 83.81 |
Secondary
Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 18
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase | -150.38 points on a scale | Standard Deviation 88.68 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 18 in the Randomized Maintenance Phase | -144.66 points on a scale | Standard Deviation 85.43 |
Secondary
Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 20
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase | -139.98 points on a scale | Standard Deviation 104.52 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 20 in the Randomized Maintenance Phase | -162.85 points on a scale | Standard Deviation 80.93 |
Secondary
Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 22
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase | -171.52 points on a scale | Standard Deviation 82.56 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 22 in the Randomized Maintenance Phase | -159.13 points on a scale | Standard Deviation 88.94 |
Secondary
Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 24
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase | -165.06 points on a scale | Standard Deviation 90.54 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 24 in the Randomized Maintenance Phase | -160.44 points on a scale | Standard Deviation 76.11 |
Secondary
Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 26
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase | -176.85 points on a scale | Standard Deviation 80.44 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 26 in the Randomized Maintenance Phase | -168.59 points on a scale | Standard Deviation 77.03 |
Secondary
Change From Baseline in CDAI Score at Week 2 of the Induction Phase
The CDAI score 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 frame: Baseline to Week 2
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 2 of the Induction Phase | -66.57 points on a scale | Standard Deviation 85.73 |
Secondary
Change From Baseline in CDAI Score at Week 4 of the Induction Phase
The CDAI score 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 frame: Baseline to Week 4
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 4 of the Induction Phase | -87.63 points on a scale | Standard Deviation 93.89 |
Secondary
Change From Baseline in CDAI Score at Week 6 of the Induction Phase
The CDAI score 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 frame: Baseline to Week 6
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 6 of the Induction Phase | -120.33 points on a scale | Standard Deviation 90.81 |
Secondary
Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase
The CDAI score 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 frame: Baseline to Week 8
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Overall | Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase | -133.35 points on a scale | Standard Deviation 85.9 |
| Q2W Regimen | Change From Baseline in CDAI Score at Week 8 in the Randomized Maintenance Phase | -137.70 points on a scale | Standard Deviation 75.89 |
Secondary
C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 0
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | C - Reactive Protein (CRP) Level at Baseline (Week 0) of the Induction Phase | 9.5 mg/L |
Secondary
CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L. Endpoint is the visit when the last observation was taken, either at week 26 or at a visit before in case of early dropout.
Time frame: Last visit on or before Week 26
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase | 6.9 mg/L |
| Q2W Regimen | CRP Level at Endpoint (Last Visit) in the Randomized Maintenance Phase | 4.8 mg/L |
Secondary
CRP Level at Week 10 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 10 (optional measurement)
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Q2W Regimen | CRP Level at Week 10 in the Randomized Maintenance Phase | 5.3 mg/L |
Secondary
CRP Level at Week 12 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 12
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 12 in the Randomized Maintenance Phase | 5.4 mg/L |
| Q2W Regimen | CRP Level at Week 12 in the Randomized Maintenance Phase | 3.7 mg/L |
Secondary
CRP Level at Week 14 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 14 (optional measurement)
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 14 in the Randomized Maintenance Phase | 0.6 mg/L |
| Q2W Regimen | CRP Level at Week 14 in the Randomized Maintenance Phase | 3.0 mg/L |
Secondary
CRP Level at Week 16 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 16
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 16 in the Randomized Maintenance Phase | 5.5 mg/L |
| Q2W Regimen | CRP Level at Week 16 in the Randomized Maintenance Phase | 4.4 mg/L |
Secondary
CRP Level at Week 18 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 18 (optional measurement)
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 18 in the Randomized Maintenance Phase | 18.4 mg/L |
| Q2W Regimen | CRP Level at Week 18 in the Randomized Maintenance Phase | 5.9 mg/L |
Secondary
CRP Level at Week 20 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 20
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 20 in the Randomized Maintenance Phase | 6.8 mg/L |
| Q2W Regimen | CRP Level at Week 20 in the Randomized Maintenance Phase | 4.4 mg/L |
Secondary
CRP Level at Week 22 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 22 (optional measurement)
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements, measurements are optional)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Q2W Regimen | CRP Level at Week 22 in the Randomized Maintenance Phase | 13.0 mg/L |
Secondary
CRP Level at Week 24 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 24
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 24 in the Randomized Maintenance Phase | 5.2 mg/L |
| Q2W Regimen | CRP Level at Week 24 in the Randomized Maintenance Phase | 4.6 mg/L |
Secondary
CRP Level at Week 26 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 26
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 26 in the Randomized Maintenance Phase | 5.4 mg/L |
| Q2W Regimen | CRP Level at Week 26 in the Randomized Maintenance Phase | 5.1 mg/L |
Secondary
CRP Level at Week 2 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 2
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 2 of the Induction Phase | 4.2 mg/L |
Secondary
CRP Level at Week 4 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 4
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 4 of the Induction Phase | 3.8 mg/L |
Secondary
CRP Level at Week 6 of the Induction Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 6
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 6 of the Induction Phase | 4.2 mg/L |
Secondary
CRP Level at Week 8 in the Randomized Maintenance Phase
High CRP levels are defined as greater or equal 5 mg/L, normal or low levels are below 5 mg/L.
Time frame: Week 8
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | CRP Level at Week 8 in the Randomized Maintenance Phase | 5.6 mg/L |
| Q2W Regimen | CRP Level at Week 8 in the Randomized Maintenance Phase | 4.6 mg/L |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 10
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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 participants |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 12
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 4 participants |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 14
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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 participants |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 16
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 8 participants |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 18
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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 participants |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 20
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 6 participants |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 22
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 7 participants |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 24
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 5 participants |
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.
Remission is defined as CDAI score ≤ 150.
Time frame: Week 26
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 5 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 10
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 12
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 14
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 16
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 10 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 18
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 8 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 20
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 7 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 22
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 8 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 24
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 5 participants |
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.
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score).
Time frame: Week 26
Population: ITTR population taking steroids at baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | 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 participants |
| Q2W Regimen | 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. | 6 participants |
Secondary
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase
Remission is defined as CDAI score ≤ 150. The CDAI score 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 frame: Week 6
Population: ITTI population: subjects who received at least one dose of study drug in the induction phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase | Remission | 212 participants |
| Overall | Remission Status With Remission Defined as CDAI Score ≤ 150 in the Induction Phase | No remission | 327 participants |
Secondary
Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase
Remission is defined as CDAI score ≤ 150. The CDAI score is used to quantify the symptoms 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 frame: Week 26
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase | Remission | 51 participants |
| Overall | Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase | No remission | 136 participants |
| Q2W Regimen | Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase | Remission | 52 participants |
| Q2W Regimen | Remission Status With Remission Defined as CDAI Score ≤ 150 in the Randomized Maintenance Phase | No remission | 134 participants |
Secondary
Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase
Response is defined as at least 100 point decrease in CDAI score from baseline. The CDAI score 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 frame: Baseline to Week 26
Population: Intent-to-treat Randomized Maintenance Phase (ITTR) population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase | Response | 70 participants |
| Overall | Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase | Non-Response | 117 participants |
| Q2W Regimen | Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase | Response | 66 participants |
| Q2W Regimen | Response Status With Response Defined as at Least 100 Point Decrease in CDAI Score From Baseline in the Randomized Maintenance Phase | Non-Response | 120 participants |
Comparison: With a sample size of 165 patients per treatment arm, assuming a percentage of responders of 45% with the Q4W regimen, the study had 80% power to show a statistically significant difference in percentage of responders at Week 26 between the two treatment groups, when there is a true difference of 16% in percentage of responders in favor of the Q2W regimen, and using a 2-sided chi-square at the 5% significance level.p-value: 0.69695% CI: [0.7, 1.7]Regression, Logistic
Secondary
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase
Response is defined as at least 70 points reduction in CDAI score. The CDAI score 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 frame: Baseline to Week 6
Population: ITTI population: all subjects who received at least one dose of study drug in the induction phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase | Response | 373 participants |
| Overall | Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Induction Phase | Non-response | 166 participants |
Secondary
Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase
Response is defined as at least 70 points reduction in CDAI score. The CDAI score 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 frame: Baseline to Week 26
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall | Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase | Response | 75 participants |
| Overall | Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase | Non-response | 112 participants |
| Q2W Regimen | Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase | Response | 75 participants |
| Q2W Regimen | Response Status With Response Defined as at Least 70 Points Reduction in CDAI Score in the Randomized Maintenance Phase | Non-response | 111 participants |
Other Pre-specified
Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6
Median time to loss of response in the maintenance period (from Kaplan-Meier analysis); range is time of first event to time of last event. Loss of response is defined as both a CDAI score \> 150 points and a minimum increase in CDAI of 70 points versus Week 6 at two consecutive visits.
Time frame: Week 6 to Week 26
Population: ITTR population: subjects who were randomized and received at least one dose of study drug in the randomized maintenance phase (available measurements)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall | Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6 | 128 days |
| Q2W Regimen | Time to Loss of Response (CDAI Score > 150 and Minimum Increase in CDAI of 70) After Week 6 | 125 days |