Crohn's Disease
Conditions
Keywords
China, Tumor necrosis factor (TNF)-alpha, Biologic
Brief summary
This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.
Interventions
BIOLOGICALadalimumab
subcutaneous injections of adalimumab
OTHERplacebo
subcutaneous injections of placebo
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Subjects of Chinese descent with full Chinese parentage. * Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0. * Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants. * Subject has a negative Tuberculosis (TB) Screening Assessment. * Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.
Exclusion criteria
* Subject with ulcerative colitis or indeterminate colitis. * Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future. * Subject with an ostomy or ileoanal pouch. * Subject who has short bowel syndrome. * Subject with symptomatic known obstructive strictures. * Subject with an internal or external fistula (with the exception of an anal fistula without abscess). * Active, or chronic or recurring infections, or active tuberculosis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 | Week 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4 | Week 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of At Least 50% From Baseline at Week 26 in Participants Who Achieved Clinical Response Plus at Least 30% Reduction in Hs-CRP From Baseline at Week 8 | Week 26 | Clinical response is defined as a decrease in CDAI ≥ 70 Points from Baseline CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 26 in Participants Who Were Taking Steroids at Baseline and Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | Week 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Discontinued Corticosteroid Use and Achieved CDAI < 150 Plus a Reduction in Hs-CRP of ≥ 50% From Baseline (BL) at Week 26 in Participants Taking Steroids at BL and Who Achieved CDAI Decrease and Hs-CRP Reduction at Week 8 | Week 26 | Percentage of participants who discontinued corticosteroid use and achieved clinical remission (CDAI \< 150) plus a reduction in hs-CRP of at least 50% from Baseline at Week 26 in participants who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI of ≥ 70 points from Baseline) plus a reduction in hs-CRP of ≥ 30% From Baseline at Week 8. CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4 | Week 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4 | Week 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Change From Baseline in Fecal Calprotectin Level at Week 4 | Baseline, Week 4 | — |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4 | Week 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | Week 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4 | Week 4 | The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life. |
| Percentage of Participants Who Achieved IBDQ Remission (IBDQ ≥ 170 Points) at Week 26 in Participants With Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | Week 26 | The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life. CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4 | Week 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | Week 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Clinical Remission at Week 26 (CDAI < 150) in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | Week 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.) |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4 | Weeks 2, 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Weeks 2, 4, 6, 8, 12, 16, 20, 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.) |
| Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4 | Weeks 2, 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. |
| Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.) |
| Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4 | Weeks 2, 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. |
| Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Weeks 2, 4, 6, 8, 12, 16, 20, 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.) |
| Change From Baseline in CDAI Over Double-Blind Weeks 0-4 | Baseline, Weeks 2, 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. |
| Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.) |
| Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 | Baseline, Weeks 2, 4 | The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. |
| Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26 | The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.) |
| Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) | Baseline (Week 0 of adalimumab), Weeks 4, 8, 26 | The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. |
| Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 | Weeks 2, 4 | CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Double-Blind Period: Adalimumab 160/80/40 mg Double-blind adalimumab 160 mg at Week 0; 80 mg at Week 2; 40 mg at Weeks 4 and 6. | 102 |
| Double-Blind Period: Placebo Followed by Adalimumab 160/80 mg Double-blind placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6. | 103 |
| Total | 205 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| DB Period/Placebo-Controlled: Weeks 0-4 | Adverse Event | 2 | 4 | 0 |
| DB Period/Placebo-Controlled: Weeks 0-4 | Other | 1 | 1 | 0 |
| DB Period/Placebo-Controlled: Weeks 0-4 | Withdrew Consent | 1 | 0 | 0 |
| DB Period: Weeks 0-8 | Adverse Event | 8 | 6 | 0 |
| DB Period: Weeks 0-8 | Other | 1 | 1 | 0 |
| DB Period: Weeks 0-8 | Withdrew Consent | 1 | 0 | 0 |
| Open Label Period: Weeks 8 to 26 | Adverse Event | 0 | 0 | 16 |
| Open Label Period: Weeks 8 to 26 | Lack of Efficacy | 0 | 0 | 9 |
| Open Label Period: Weeks 8 to 26 | Subject Noncompliance | 0 | 0 | 2 |
| Open Label Period: Weeks 8 to 26 | Withdrew Consent | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | Double-Blind Period: Placebo Followed by Adalimumab 160/80 mg | Total | Double-Blind Period: Adalimumab 160/80/40 mg |
|---|---|---|---|
| Age, Continuous | 32.6 years STANDARD_DEVIATION 9.5 | 32.9 years STANDARD_DEVIATION 9.85 | 33.2 years STANDARD_DEVIATION 10.24 |
| Crohn's Disease Activity Index (CDAI) | 274.71 units on a scale STANDARD_DEVIATION 49.055 | 273.38 units on a scale STANDARD_DEVIATION 48.49 | 272.05 units on a scale STANDARD_DEVIATION 48.117 |
| Fecal Calprotectin | 1435.4 μg/g STANDARD_DEVIATION 766.37 | 1458.4 μg/g STANDARD_DEVIATION 786.2 | 1481.8 μg/g STANDARD_DEVIATION 809.29 |
| High Sensitivity C-Reactive Protein (Hs-CRP) | 27.12 mg/L STANDARD_DEVIATION 31.526 | 25.53 mg/L STANDARD_DEVIATION 28.266 | 23.93 mg/L STANDARD_DEVIATION 24.595 |
| Race/Ethnicity, Customized Chinese | 103 Participants | 205 Participants | 102 Participants |
| Sex: Female, Male Female | 30 Participants | 65 Participants | 35 Participants |
| Sex: Female, Male Male | 73 Participants | 140 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 103 | 0 / 102 | 0 / 200 |
| other Total, other adverse events | 18 / 103 | 25 / 102 | 137 / 200 |
| serious Total, serious adverse events | 1 / 103 | 2 / 102 | 36 / 200 |
Outcome results
Primary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4
Population: Intention to Treat (ITT) Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 | 6.8 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) at Week 4 | 37.3 percentage of participants |
p-value: <0.00195% CI: [19.2, 41.7]Cochran-Mantel-Haenszel
Secondary
Change From Baseline in CDAI Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Time frame: Baseline, Weeks 2, 4
Population: ITT Set: all participants who were randomized. Observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Double-Blind Weeks 0-4 | Week 4 | -38.22 units on a scale | Standard Deviation 60.918 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Double-Blind Weeks 0-4 | Week 2 | -30.97 units on a scale | Standard Deviation 53.699 |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Change From Baseline in CDAI Over Double-Blind Weeks 0-4 | Week 2 | -73.66 units on a scale | Standard Deviation 63.267 |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Change From Baseline in CDAI Over Double-Blind Weeks 0-4 | Week 4 | -104.56 units on a scale | Standard Deviation 67.325 |
Comparison: Change From Baseline in CDAI at Week 2p-value: <0.00195% CI: [-59.39, -27.3]ANCOVA
Comparison: Change From Baseline in CDAI at Week 4p-value: <0.00195% CI: [-84.2, -49.06]ANCOVA
Secondary
Change From Baseline in CDAI Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Time frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 6 | -103.62 units on a scale | Standard Deviation 79.094 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 8 | -115.96 units on a scale | Standard Deviation 83.9 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 10 | -122.51 units on a scale | Standard Deviation 82.991 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 22 | -143.99 units on a scale | Standard Deviation 77.972 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 26 | -178.74 units on a scale | Standard Deviation 54.277 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 2 | -67.31 units on a scale | Standard Deviation 67.268 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 4 | -92.60 units on a scale | Standard Deviation 74.666 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 12 | -131.55 units on a scale | Standard Deviation 76.754 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 14 | -136.85 units on a scale | Standard Deviation 76.459 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 16 | -143.56 units on a scale | Standard Deviation 72.597 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 18 | -140.40 units on a scale | Standard Deviation 77.473 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 20 | -147.54 units on a scale | Standard Deviation 72.352 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in CDAI Over Time (Any Adalimumab Set) | Week 24 | -182.01 units on a scale | Standard Deviation 54.588 |
Secondary
Change From Baseline in Fecal Calprotectin Level at Week 4
Time frame: Baseline, Week 4
Population: ITT Set: all participants who were randomized. Observed cases.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Fecal Calprotectin Level at Week 4 | -66.3 μg/g | Standard Deviation 844.89 |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Change From Baseline in Fecal Calprotectin Level at Week 4 | -499.5 μg/g | Standard Deviation 868.62 |
p-value: <0.00195% CI: [-598.81, -171.5]ANCOVA
Secondary
Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set)
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Time frame: Baseline (Week 0 of adalimumab), Weeks 4, 8, 26
Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) | Week 4 | -425.7 μg/g | Standard Deviation 940.04 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) | Week 8 | -529.6 μg/g | Standard Deviation 913.5 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Fecal Calprotectin Level Over Time (Any Adalimumab Set) | Week 26 | -475.6 μg/g | Standard Deviation 978.07 |
Secondary
Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Time frame: Baseline, Weeks 2, 4
Population: ITT Set: all participants who were randomized. Observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 | Week 2 | -4.149 mg/L | Standard Deviation 22.1944 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 | Week 4 | -1.131 mg/L | Standard Deviation 18.8392 |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 | Week 2 | -16.474 mg/L | Standard Deviation 25.5491 |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Change From Baseline in Hs-CRP Level Over Double-Blind Weeks 0-4 | Week 4 | -16.670 mg/L | Standard Deviation 19.9088 |
Comparison: Change From Baseline in hs-CRP Level at Week 2p-value: <0.00195% CI: [-19.183, -8.659]ANCOVA
Comparison: Change From Baseline in hs-CRP Level at Week 4p-value: <0.00195% CI: [-21.206, -12.483]ANCOVA
Secondary
Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set)
The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Time frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26
Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Week 6 | -12.295 mg/L | Standard Deviation 20.9586 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Week 8 | -14.565 mg/L | Standard Deviation 18.5093 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Week 12 | -13.527 mg/L | Standard Deviation 19.9087 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Week 20 | -11.921 mg/L | Standard Deviation 18.4776 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Week 26 | -12.308 mg/L | Standard Deviation 14.4531 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Week 2 | -16.923 mg/L | Standard Deviation 23.8242 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Week 4 | -17.064 mg/L | Standard Deviation 21.8366 |
| Double-Blind Period, Weeks 0 to 4: Placebo | Change From Baseline in Hs-CRP Level Over Time (Any Adalimumab Set) | Week 16 | -13.504 mg/L | Standard Deviation 18.1452 |
Secondary
Percentage of Participants Who Achieved Clinical Remission at Week 26 (CDAI < 150) in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 26
Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission at Week 26 (CDAI < 150) in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | 64.6 percentage of participants |
p-value: <0.00195% CI: [26.2, 42.4]One Sample Exact Test
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4 | 0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) and Hs-CRP < 3 mg/L at Week 4 | 27.5 percentage of participants |
p-value: <0.00195% CI: [18.2, 37]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 26
Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | 16.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4 | 0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L and Fecal Calprotectin < 250 μg/g at Week 4 | 9.8 percentage of participants |
p-value: 0.00195% CI: [3.9, 15.8]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 26
Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150), Hs-CRP < 3 mg/L at Week 26 in Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | 36.8 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Time frame: Weeks 2, 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 | Week 2 | 7.8 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 | Week 4 | 6.8 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 | Week 2 | 26.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Double-Blind Weeks 0-4 | Week 4 | 37.3 percentage of participants |
Comparison: Clinical Remission at Week 2p-value: <0.00195% CI: [8.2, 28.6]Cochran-Mantel-Haenszel
Comparison: Clinical Remission at Week 4p-value: <0.00195% CI: [19.2, 41.7]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Time frame: Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Baseline | 3.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 6 | 48.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 20 | 53.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 2 | 31.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 4 | 40.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 8 | 55.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 10 | 45.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 12 | 56.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 14 | 51.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 16 | 56.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 18 | 48.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 22 | 52.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 24 | 49.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Over Time (Any Adalimumab Set) | Week 26 | 53.9 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of At Least 50% From Baseline at Week 26 in Participants Who Achieved Clinical Response Plus at Least 30% Reduction in Hs-CRP From Baseline at Week 8
Clinical response is defined as a decrease in CDAI ≥ 70 Points from Baseline CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 26
Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) plus at least 30% reduction in hs-CRP from Baseline at Week 8. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of At Least 50% From Baseline at Week 26 in Participants Who Achieved Clinical Response Plus at Least 30% Reduction in Hs-CRP From Baseline at Week 8 | 55.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4 | 0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline at Week 4 | 33.3 percentage of participants |
p-value: <0.00195% CI: [23.2, 43.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Time frame: Weeks 2, 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4 | Week 2 | 1.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4 | Week 4 | 0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4 | Week 2 | 22.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus A Reduction in Hs-CRP of at Least 50% From Baseline Over Double-Blind Weeks 0-4 | Week 4 | 33.3 percentage of participants |
Comparison: Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 2p-value: <0.00195% CI: [12.6, 30.2]Cochran-Mantel-Haenszel
Comparison: Clinical Remission (CDAI \< 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4p-value: <0.00195% CI: [23.2, 43.6]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 26
Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Week 4 | 36.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Week 2 | 27.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Week 6 | 26.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Week 8 | 45.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Week 12 | 43.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Week 16 | 44.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Week 20 | 42.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Remission (CDAI < 150) Plus a Reduction in Hs-CRP of at Least 50% From Baseline Over Time (Any Adalimumab Set) | Week 26 | 39.2 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4 | 27.2 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4 | 67.6 percentage of participants |
p-value: <0.00195% CI: [26.7, 54.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Time frame: Weeks 2, 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4 | Week 2 | 22.3 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4 | Week 4 | 27.2 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4 | Week 2 | 44.1 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Double-Blind Weeks 0-4 | Week 4 | 67.6 percentage of participants |
Comparison: Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 2p-value: 0.00195% CI: [8.7, 34.6]Cochran-Mantel-Haenszel
Comparison: Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4p-value: <0.00195% CI: [26.7, 54.2]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Time frame: Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26
Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 10 | 54.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 2 | 45.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 4 | 59.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 6 | 60.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 8 | 64.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 12 | 58.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 14 | 54.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 16 | 58.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 18 | 49.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 20 | 54.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 22 | 50.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 24 | 52.9 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Over Time (Any Adalimumab Set) | Week 26 | 59.8 percentage of participants |
Secondary
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4 | 11.7 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4 | 61.8 percentage of participants |
p-value: <0.00195% CI: [36.9, 63.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment.
Time frame: Weeks 2, 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4 | Week 2 | 8.7 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4 | Week 4 | 11.7 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4 | Week 2 | 40.2 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Double-Blind Weeks 0-4 | Week 4 | 61.8 percentage of participants |
Comparison: Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 2p-value: <0.00195% CI: [19.6, 43.2]Cochran-Mantel-Haenszel
Comparison: Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4p-value: <0.00195% CI: [36.9, 63.5]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set)
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450. The analysis over time was performed for the DB placebo-controlled period (Week 0 to Week 4), with comparisons between active treatment and placebo groups. The analysis over time was also performed for Any Adalimumab set (the entire study on or after the first dose of adalimumab), with only summary statistics for adalimumab treatment. (Note: the analysis window for the 'Any Adalimumab Set' is different from that used for the ITT population. For the Any Adalimumab Set, the Baseline Visit date is the date when the first dose of adalimumab was received, and was counted as Day 1 or Week 0.)
Time frame: Weeks 2, 4, 6, 8, 12, 16, 20, 26
Population: Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Week 2 | 41.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Week 8 | 55.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Week 16 | 51.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Week 4 | 55.0 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Week 6 | 35.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Week 12 | 49.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Week 20 | 45.5 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) Plus a Reduction in Hs-CRP of at Least 30% From Baseline Over Time (Any Adalimumab Set) | Week 26 | 52.0 percentage of participants |
Secondary
Percentage of Participants Who Achieved IBDQ Remission (IBDQ ≥ 170 Points) at Week 26 in Participants With Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life. CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 26
Population: All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved IBDQ Remission (IBDQ ≥ 170 Points) at Week 26 in Participants With Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | 51.4 percentage of participants |
Secondary
Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Time frame: Week 4
Population: ITT Set: all participants who were randomized. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4 | 20.4 percentage of participants |
| Double-Blind Period, Weeks 0 to 4: Adalimumab 160/80 mg | Percentage of Participants Who Achieved Inflammatory Bowel Disease Questionnaire (IBDQ) Remission (IBDQ ≥ 170 Points) at Week 4 | 40.2 percentage of participants |
p-value: 0.00295% CI: [7.1, 32.1]Cochran-Mantel-Haenszel
Secondary
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved CDAI < 150 Plus a Reduction in Hs-CRP of ≥ 50% From Baseline (BL) at Week 26 in Participants Taking Steroids at BL and Who Achieved CDAI Decrease and Hs-CRP Reduction at Week 8
Percentage of participants who discontinued corticosteroid use and achieved clinical remission (CDAI \< 150) plus a reduction in hs-CRP of at least 50% from Baseline at Week 26 in participants who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI of ≥ 70 points from Baseline) plus a reduction in hs-CRP of ≥ 30% From Baseline at Week 8. CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 26
Population: All participants who were randomized and who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) plus a reduction in hs-CRP of at least 30% from Baseline at Week 8. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Discontinued Corticosteroid Use and Achieved CDAI < 150 Plus a Reduction in Hs-CRP of ≥ 50% From Baseline (BL) at Week 26 in Participants Taking Steroids at BL and Who Achieved CDAI Decrease and Hs-CRP Reduction at Week 8 | 57.6 percentage of participants |
Secondary
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 26 in Participants Who Were Taking Steroids at Baseline and Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI \< 150, and very severe disease is defined as CDAI \> 450.
Time frame: Week 26
Population: All participants who were randomized and who were taking steroids at Baseline and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Double-Blind Period, Weeks 0 to 4: Placebo | Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 26 in Participants Who Were Taking Steroids at Baseline and Who Achieved Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 8 | 62.8 percentage of participants |