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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Induction Regimen | Experimental | Double-blind period (Weeks 0-8): Placebo at Weeks 0 and 2, followed by adalimumab 160 mg at Week 4, 80 mg at Week 6. Open label period: adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24. |
|
| Adalimumab Induction Regimen | Experimental | Double-blind period (Weeks 0-8): adalimumab 160 mg at Weeks 0 and 80 mg at Week 2, followed by adalimumab 40 mg at Week 4 and Week 6. Open label period: adalimumab 40 mg eow from Week 8 through last dose at Week 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | subcutaneous injections of adalimumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32733600 | Derived | Chen B, Gao X, Zhong J, Ren J, Zhu X, Liu Z, Wu K, Kalabic J, Yu Z, Huang B, Kwatra N, Doan T, Robinson AM, Chen MH. Efficacy and safety of adalimumab in Chinese patients with moderately to severely active Crohn's disease: results from a randomized trial. Ther Adv Gastroenterol. 2020 Jul 16;13:1756284820938960. doi: 10.1177/1756284820938960. eCollection 2020. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Double-Blind (DB) 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. |
| FG001 | DB 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. |
| FG002 | Open-Label (OL) Period: Adalimumab 40 mg | Open-label adalimumab 40 mg every other week (eow) from Week 8 through last dose at Week 24. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DB Period/Placebo-Controlled: Weeks 0-4 |
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| DB Period: Weeks 0-8 |
| ||||||||||||||||||||||
| Open Label Period: Weeks 8 to 26 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Double-Blind Period: Placebo Followed by Adalimumab 160/80 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention to Treat (ITT) Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 4 |
|
Treatment-emergent adverse events (TEAEs): from first dose of study drug through last dose (Week 24) plus 70 days.
A TEAE during Week 0-4 of DB period=any event with an onset date on or after first dose of study drug and up to first dose of study drug at Week 4 or within 70 days after the last dose of study drug in Week0-4 of DB period for participants who discontinued prior to Week 4.
A TEAE during DB or OL period of Any Adalimumab=any event with an onset date on or after first dose of adalimumab in the DB/OL periods and within 70 days after the last dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double-Blind Placebo Weeks 0-4 | Double-blind placebo at Weeks 0 and 2. | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2015 | May 4, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 26, 2017 | May 4, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| placebo | Other | subcutaneous injections of placebo |
|
| Week 26 |
| 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. | Week 4 |
| 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. | Week 26 |
| 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. | Week 26 |
| 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. | Week 26 |
| 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. | Week 4 |
| 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. | Week 4 |
| 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. | Week 4 |
| 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. | Week 26 |
| 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. | Week 4 |
| 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. | Week 26 |
| Change From Baseline in Fecal Calprotectin Level at Week 4 | Baseline, Week 4 |
| 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. | Week 4 |
| 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. | Week 26 |
| 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. | Weeks 2, 4 |
| 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.) | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 |
| 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. | Weeks 2, 4 |
| 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.) | Weeks 2, 4, 6, 8, 12, 16, 20, 26 |
| 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. | Weeks 2, 4 |
| 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.) | Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 |
| 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. | Weeks 2, 4 |
| 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.) | Weeks 2, 4, 6, 8, 12, 16, 20, 26 |
| 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. | Baseline, Weeks 2, 4 |
| 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.) | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 |
| 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. | Baseline, Weeks 2, 4 |
| 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.) | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26 |
| 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. | Baseline (Week 0 of adalimumab), Weeks 4, 8, 26 |
| Other |
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| NOT COMPLETED |
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| NOT COMPLETED |
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Double-blind placebo at Weeks 0 and 2, adalimumab 160 mg at Week 4, 80 mg at Week 6.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Crohn's Disease Activity Index (CDAI) | CDAI is used to quantify the symptoms of subjects with Crohn's Disease. It generally ranges from 0 up to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. | Mean | Standard Deviation | units on a scale |
|
| High Sensitivity C-Reactive Protein (Hs-CRP) | Mean | Standard Deviation | mg/L |
|
| Fecal Calprotectin | Mean | Standard Deviation | μg/g |
|
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|
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| 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. | All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation. | Posted | Number | percentage of participants | Week 26 |
|
|
|
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 4 |
|
|
|
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| 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. | 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. | Posted | Number | percentage of participants | Week 26 |
|
|
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| 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. | 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. | Posted | Number | percentage of participants | Week 26 |
|
|
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| 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. | 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. | Posted | Number | percentage of participants | Week 26 |
|
|
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 4 |
|
|
|
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 4 |
|
|
|
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 4 |
|
|
|
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| 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. | All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation. | Posted | Number | percentage of participants | Week 26 |
|
|
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 4 |
|
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|
| 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. | All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation. | Posted | Number | percentage of participants | Week 26 |
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| Secondary | Change From Baseline in Fecal Calprotectin Level at Week 4 | ITT Set: all participants who were randomized. Observed cases. | Posted | Mean | Standard Deviation | μg/g | Baseline, Week 4 |
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Week 4 |
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| 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. | All participants who were randomized and who achieved clinical response (decrease in CDAI ≥ 70 points from Baseline) at Week 8. Non-responder imputation. | Posted | Number | percentage of participants | Week 26 |
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Weeks 2, 4 |
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| 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.) | Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation. | Posted | Number | percentage of participants | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 |
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Weeks 2, 4 |
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| 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.) | Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation. | Posted | Number | percentage of participants | Weeks 2, 4, 6, 8, 12, 16, 20, 26 |
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Weeks 2, 4 |
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| 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.) | Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation. | Posted | Number | percentage of participants | Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 |
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| 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. | ITT Set: all participants who were randomized. Non-responder imputation. | Posted | Number | percentage of participants | Weeks 2, 4 |
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|
|
| 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.) | Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Non-responder imputation. | Posted | Number | percentage of participants | Weeks 2, 4, 6, 8, 12, 16, 20, 26 |
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| 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. | ITT Set: all participants who were randomized. Observed cases. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 2, 4 |
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| 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.) | Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 |
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| 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. | ITT Set: all participants who were randomized. Observed cases. | Posted | Mean | Standard Deviation | mg/L | Baseline, Weeks 2, 4 |
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| 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.) | Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases. | Posted | Mean | Standard Deviation | mg/L | Baseline (Week 0 of adalimumab), Weeks 2, 4, 6, 8, 12, 16 20, 26 |
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| 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. | Any Adalimumab Set: all participants who received at least 1 injection of adalimumab. Observed cases. | Posted | Mean | Standard Deviation | μg/g | Baseline (Week 0 of adalimumab), Weeks 4, 8, 26 |
|
|
|
| 103 |
| 1 |
| 103 |
| 18 |
| 103 |
| EG001 | Double-Blind Adalimumab 160/80 mg Weeks 0-4 | Double-blind adalimumab 160/80 mg at Weeks 0 and 2. | 0 | 102 | 2 | 102 | 25 | 102 |
| EG002 | Any Adalimumab | Any adalimumab, from first dose of adalimumab to last dose at Week 24. | 0 | 200 | 36 | 200 | 137 | 200 |
| ABDOMINAL MASS | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| ANAL FISTULA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| ENTEROVESICAL FISTULA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| GASTROINTESTINAL FISTULA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| GASTROINTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| ILEAL PERFORATION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| ILEUS | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| INTESTINAL FISTULA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| INTESTINAL MASS | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| INTESTINAL PERFORATION | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| LARGE INTESTINE POLYP | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| RECTAL POLYP | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| ABDOMINAL ABSCESS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| COLONIC ABSCESS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| GASTROINTESTINAL INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| LUNG INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| PERITONITIS | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| TOXIC SHOCK SYNDROME | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| URINARY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| CLAVICLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (20.0) | Systematic Assessment |
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| MALNUTRITION | Metabolism and nutrition disorders | MedDRA (20.0) | Systematic Assessment |
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| PITYRIASIS ROSEA | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
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| ABORTION INDUCED | Surgical and medical procedures | MedDRA (20.0) | Systematic Assessment |
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| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA (20.0) | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA (20.0) | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
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| MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE | Investigations | MedDRA (20.0) | Systematic Assessment |
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| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA (20.0) | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (20.0) | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D007410 | Intestinal Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Clinical Remission at Week 4 | Cochran-Mantel-Haenszel | < 0.001 | Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline. | Adjusted Risk Difference | 30.4 | 2-Sided | 95 | 19.2 | 41.7 | Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline. | Superiority |
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| Week 4 |
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| Week 6 |
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| Week 8 |
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| Week 10 |
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| Week 12 |
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| Week 14 |
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| Week 16 |
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| Week 18 |
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| Week 20 |
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| Week 22 |
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| Week 24 |
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| Week 26 |
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| Clinical Remission (CDAI < 150) Plus A Reduction in HS-CRP of at Least 50% From Baseline at Week 4 | Cochran-Mantel-Haenszel | < 0.001 | Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline. | Adjusted Risk Difference | 33.4 | 2-Sided | 95 | 23.2 | 43.6 | Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline. | Superiority |
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| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 26 |
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| Clinical Response (Decrease in CDAI ≥ 70 Points From Baseline) at Week 4 | Cochran-Mantel-Haenszel | < 0.001 | Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline. | Adjusted Risk Difference | 40.4 | 2-Sided | 95 | 26.7 | 54.2 | Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline. | Superiority |
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| Week 6 |
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| Week 8 |
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| Week 10 |
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| Week 12 |
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| Week 14 |
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| Week 16 |
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| Week 18 |
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| Week 20 |
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| Week 22 |
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| Week 24 |
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| Week 26 |
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| Decrease in CDAI ≥ 70 Points From Baseline Plus a Reduction in Hs-CRP of at Least 30% From Baseline at Week 4 | Cochran-Mantel-Haenszel | < 0.001 | Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline. | Adjusted Risk Difference | 50.2 | 2-Sided | 95 | 36.9 | 63.5 | Risk difference = (adalimumab 160/80 mg - placebo). Based on Cochran-Mantel-Haenszel test stratified by Crohn's disease severity (CDAI <= 300 and CDAI >300) at baseline and corticosteroid use at baseline. | Superiority |
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| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 26 |
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| Week 4 |
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Change From Baseline in CDAI at Week 4 |
| ANCOVA |
| < 0.001 |
P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate. |
| Least Squares Mean Difference |
| -66.63 |
| 2-Sided |
| 95 |
| -84.20 |
| -49.06 |
| Superiority |
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| Week 6 |
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| Week 8 |
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| Week 10 |
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| Week 12 |
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| Week 14 |
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| Week 16 |
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| Week 18 |
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| Week 20 |
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| Week 22 |
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| Week 24 |
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| Week 26 |
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| Week 4 |
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Change From Baseline in hs-CRP Level at Week 4 |
| ANCOVA |
| < 0.001 |
P-value for test of difference between adalimumab and placebo for mean change from Baseline using ANCOVA with Treatment, Crohn's disease severity (CDAI <= 300, > 300) at Baseline and corticosteroid use at Baseline, and Baseline value as covariate. |
| Least Squares Mean Difference |
| -16.844 |
| 2-Sided |
| 95 |
| -21.206 |
| -12.483 |
| Superiority |
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| Week 6 |
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| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 20 |
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| Week 26 |
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| Week 26 |
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