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| Name | Class |
|---|---|
| Eisai Co., Ltd. | INDUSTRY |
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To investigate efficacy, safety and pharmacokinetics of adalimumab subcutaneous (sc) for Japanese subjects with intestinal Behçet's disease who are refractory to conventional therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Experimental | Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Marked Improvement at Week 24 | Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Marked Improvement at Week 52 | Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morio Ozawa, MS | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 46738 | Chikushino-shi | Japan | ||||
| Site Reference ID/Investigator# 46723 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28670237 | Derived | Inoue N, Kobayashi K, Naganuma M, Hirai F, Ozawa M, Arikan D, Huang B, Robinson AM, Thakkar RB, Hibi T. Long-term safety and efficacy of adalimumab for intestinal Behcet's disease in the open label study following a phase 3 clinical trial. Intest Res. 2017 Jul;15(3):395-401. doi: 10.5217/ir.2017.15.3.395. Epub 2017 Jun 12. | |
| 25245624 |
| Label | URL |
|---|---|
| Related info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan. |
| 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 | Number of Participants With Marked Improvement at Week 24 | Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). | Full analysis set (all participants). Those with missing evaluations were imputed as non-responders. | Posted | Number | participants | 24 weeks |
Adverse Events (AEs) were reported from the time of study drug administration up to 124 weeks + 70 days following discontinuation of study drug. Serious AEs were collected from the time the participant signed the study-specific informed consent.
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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 | Adalimumab | Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| AUTOIMMUNE THYROIDITIS | Endocrine disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
Not provided
| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 52 weeks |
| Number of Participants With Complete Remission at Week 24 and Week 52 | Complete remission was defined as both endoscopic improvement and global assessment of gastrointestinal symptoms grades of 0. Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). Global assessment of gastrointestinal symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. | 24 weeks, 52 weeks |
| Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52 | Study participants completed a global assessment of their gastrointestinal symptoms (Behçet's disease symptoms other than gastrointestinal symptoms were excluded) during 2 weeks before assessment visit on a 5-grade scale. The investigator confirmed this assessment via interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Global assessment of grade 0 or ≤1 and improvement of ≥1 (from baseline) is presented. | 24 weeks, 52 weeks |
| Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52 | Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). | 24 weeks, 52 weeks |
| Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52 | Participants assessed their abdominal pain, diarrhea and other gastrointestinal symptoms (abdominal discomfort, abdominal fullness, etc) during 2 weeks before assessment visit in 5 grades. Investigator confirmed the assessment through interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Improvement of ≥1 grade from baseline is also presented. | 24 weeks, 52 weeks |
| Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52 | Investigators assessed oral aphthous (mouth ulcers), skin symptoms, eye symptoms and vulval (genital) ulcers during 4 weeks before study visit via participant interview, using the following grades. Oral aphthous: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Skin (Erythema nodosum rash): 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Eye (Uveitis): 0=None; 1=one eye crisis in recent 4 weeks; 2=two eye crises in recent 4 weeks; 3=three eye crises in recent 4 weeks. Vulval (genital) ulcer: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Resolution was defined as: Behçet's disease symptoms other than gastrointestinal symptoms were graded 0 (disappeared). | 24 weeks, 52 weeks |
| Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52 | Inflammatory Bowel Disease Questionnaire (IBDQ) is the standard questionnaire to assess the quality of life of patients with inflammatory bowel disease. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Baseline, 24 weeks, 52 weeks |
| Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52 | The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). The mental component reflects vitality, social functioning, role-emotional and mental health. Score on the mental component ranges from 0 (poorest health) to 100 (best health). | Baseline, 24 weeks, 52 weeks |
| Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52 | C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL. | Baseline, 24 weeks, 52 weeks |
| Kurume |
| Japan |
| Site Reference ID/Investigator# 46728 | Nagoya | Japan |
| Site Reference ID/Investigator# 46725 | Nishinomiya-shi | Japan |
| Site Reference ID/Investigator# 46730 | Osaka | Japan |
| Site Reference ID/Investigator# 46722 | Sagamihara-shi | Japan |
| Site Reference ID/Investigator# 46726 | Sakura | Japan |
| Site Reference ID/Investigator# 59578 | Sapporo | Japan |
| Site Reference ID/Investigator# 46724 | Takatsuki-shi | Japan |
| Site Reference ID/Investigator# 46729 | Tokyo | Japan |
| Site Reference ID/Investigator# 46737 | Tokyo | Japan |
| Site Reference ID/Investigator# 46733 | Yokohama | Japan |
| Tanida S, Inoue N, Kobayashi K, Naganuma M, Hirai F, Iizuka B, Watanabe K, Mitsuyama K, Inoue T, Ishigatsubo Y, Suzuki Y, Nagahori M, Motoya S, Nakamura S, Arora V, Robinson AM, Thakkar RB, Hibi T. Adalimumab for the treatment of Japanese patients with intestinal Behcet's disease. Clin Gastroenterol Hepatol. 2015 May;13(5):940-8.e3. doi: 10.1016/j.cgh.2014.08.042. Epub 2014 Sep 19. |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Longest Diameter of Ileocecal Largest Open Ulcer | Number of participants with longest diameter of ileocecal largest open ulcer in each of 3 categories, as determined by screening (baseline) endoscopy. | Number | participants |
|
| Global Assessment of Gastrointestinal (GI) Symptoms Grade | Global assessment of gastrointestinal symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. | Number | participants |
|
| Assessment of Abdominal Pain (GI Symptom Component) Grade | Assessment of gastrointestinal symptom component of abdominal pain via a participant-assessed, investigator-confirmed grading of symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. | Number | participants |
|
| Assessment of Diarrhea (GI Symptom Component) Grade | Assessment of gastrointestinal symptom component of diarrhea via a participant-assessed, investigator-confirmed grading of symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. | Number | participants |
|
| Assessment of Other Symptoms (GI Symptom Component) Grade | Assessment of gastrointestinal symptoms other than abdominal pain or diarrhea (abdominal discomfort/fullness, etc) via a participant-assessed, investigator-confirmed grading of symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Scores assess symptoms in the 2 weeks prior to Baseline. | Number | participants |
|
| Assessment of Behçet's Disease Symptoms (Other Than GI Symptoms) Grade | Investigators assessed oral aphthous, skin symptoms (erythema nodosum rash), eye symptoms (uveitis) and vulval (genital) ulcers during 4 weeks before baseline visit via participant interview at baseline, using the following grades: 0=None; 1=Symptom existed less than 2 weeks, or 1 eye crisis in recent 4 weeks; 2=Symptom existed 2 weeks or more, or 2 eye crises in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks, or 3 eye crises in recent 4 weeks. | Number | participants |
|
| Inflammatory Bowel Disease Questionnaire (IBDQ) | Inflammatory Bowel Disease Questionnaire (IBDQ) is the standard questionnaire to assess the quality of life of patients with inflammatory bowel disease. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function, and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Mean | Standard Deviation | units on a scale |
|
| Short-Form-36 (SF-36) Summary Scores | The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain, and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). The mental component reflects vitality, social functioning, role-emotional, and mental health. Score on the mental component ranges from 0 (poorest health) to 100 (best health). | Mean | Standard Deviation | units on a scale |
|
| C-Reactive Protein (CRP) | C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL. | Mean | Standard Deviation | mg/dL |
|
| ID |
|---|
| Title |
|---|
| Description |
|---|
| OG000 | Adalimumab | Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan. |
|
|
| Secondary | Number of Participants With Marked Improvement at Week 52 | Marked improvement is defined as the combination of both global assessment of gastrointestinal (GI) symptoms and endoscopic improvement grades of ≤1. Global assessment of GI symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Endoscopic improvement was assessed in 4 grades compared to the screening endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). | Full analysis set (all participants). Those with missing evaluations were imputed as non-responders. | Posted | Number | participants | 52 weeks |
|
|
|
| Secondary | Number of Participants With Complete Remission at Week 24 and Week 52 | Complete remission was defined as both endoscopic improvement and global assessment of gastrointestinal symptoms grades of 0. Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). Global assessment of gastrointestinal symptoms is a participant-assessed, investigator-confirmed grading of global symptoms from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. | Full analysis set (all participants). Those with missing evaluations were imputed as non-responders. | Posted | Number | participants | 24 weeks, 52 weeks |
|
|
|
| Secondary | Number of Participants With a Global Assessment of Gastrointestinal Symptoms Grade 0 or ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52 | Study participants completed a global assessment of their gastrointestinal symptoms (Behçet's disease symptoms other than gastrointestinal symptoms were excluded) during 2 weeks before assessment visit on a 5-grade scale. The investigator confirmed this assessment via interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Global assessment of grade 0 or ≤1 and improvement of ≥1 (from baseline) is presented. | Full analysis set (all participants). Those with missing evaluations were imputed as non-responders. | Posted | Number | participants | 24 weeks, 52 weeks |
|
|
|
| Secondary | Number of Participants With Endoscopic Improvement Grades 0, ≤1 and ≤2 at Week 24 and Week 52 | Endoscopic improvement was assessed in 4 grades compared to the screening (baseline) endoscopy based on the longest diameter (none, ≥1 cm to <2 cm, ≥2 cm to <3 cm, ≥3 cm) of ileocecal largest open ulcer (area of mucosal defect). Grades are: 0=healing; 1=marked reduction (reduction to ≤1/4); 2=reduction (reduction to ≤1/2 - 1/4); 3=no change or worse (reduction less than 1/2 or expansion). | Full analysis set (all participants). Those with missing evaluations were imputed as non-responders. | Posted | Number | participants | 24 weeks, 52 weeks |
|
|
|
| Secondary | Number of Participants With Abdominal Pain, Diarrhea and Other Gastrointestinal (GI) Symptoms Grade ≤1 and Improvement of ≥1 Grade at Week 24 and Week 52 | Participants assessed their abdominal pain, diarrhea and other gastrointestinal symptoms (abdominal discomfort, abdominal fullness, etc) during 2 weeks before assessment visit in 5 grades. Investigator confirmed the assessment through interview with participants. Assessment is graded from 0 to 4: 0=free of symptoms; 1=symptoms existed in past 2 weeks but did not affect participant's daily life; 2=symptoms existed in past 2 weeks and slightly affected participant's daily life; 3=symptoms existed in past 2 weeks and affected participant's daily life; 4=symptoms existed in past 2 weeks and critically affected participant's daily life. Improvement of ≥1 grade from baseline is also presented. | Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders. | Posted | Number | participants | 24 weeks, 52 weeks |
|
|
|
| Secondary | Number of Participants With Resolution of Behçet's Disease Symptoms (Other Than Gastrointestinal Symptoms) at Week 24 and Week 52 | Investigators assessed oral aphthous (mouth ulcers), skin symptoms, eye symptoms and vulval (genital) ulcers during 4 weeks before study visit via participant interview, using the following grades. Oral aphthous: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Skin (Erythema nodosum rash): 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Eye (Uveitis): 0=None; 1=one eye crisis in recent 4 weeks; 2=two eye crises in recent 4 weeks; 3=three eye crises in recent 4 weeks. Vulval (genital) ulcer: 0=None; 1=Symptom existed less than 2 weeks in recent 4 weeks; 2=Symptom existed 2 weeks or more in recent 4 weeks; 3=Symptom existed mostly in recent 4 weeks. Resolution was defined as: Behçet's disease symptoms other than gastrointestinal symptoms were graded 0 (disappeared). | Full analysis set (all participants). n=number of participants who had any symptom at baseline. Those with missing evaluations were imputed as non-responders. | Posted | Number | participants | 24 weeks, 52 weeks |
|
|
|
| Secondary | Mean Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Week 24 and Week 52 | Inflammatory Bowel Disease Questionnaire (IBDQ) is the standard questionnaire to assess the quality of life of patients with inflammatory bowel disease. The IBDQ is a 32-item questionnaire consisting of 4 dimensions: bowel-related symptoms, systemic function, social function and emotional status. The responses to each question within each domain range from 1 (significant impairment) to 7 (no impairment), with total score ranging from 32 (very poor) to 224 (perfect health-related quality of life). | Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 24 weeks, 52 weeks |
|
|
|
| Secondary | Mean Change From Baseline in Short Form-36 (SF-36) Summary Scores at Week 24 and Week 52 | The Short-Form-36 (SF-36) Health Survey is a comprehensive quality of life scale. An increase in SF-36 score indicates alleviation of the disease and a decrease in score indicates aggravation of disease. The physical component reflects activity level, activity limitations, pain and rating of one's health. Score on the physical component ranges from 0 (poorest health) to 100 (best health). The mental component reflects vitality, social functioning, role-emotional and mental health. Score on the mental component ranges from 0 (poorest health) to 100 (best health). | Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 24 weeks, 52 weeks |
|
|
|
| Secondary | Median Change From Baseline in C-Reactive Protein (CRP) at Week 24 and Week 52 | C-Reactive Protein (CRP) normal range was defined as ≤0.3 mg/dL. | Full analysis set (all participants). Those with missing evaluations were imputed by last observation carried forward. | Posted | Mean | Standard Deviation | mg/dL | Baseline, 24 weeks, 52 weeks |
|
|
|
| 6 |
| 20 |
| 20 |
| 20 |
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| LOWER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| SUBILEUS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| BEHCET'S SYNDROME | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| ABSCESS INTESTINAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| APPENDICITIS PERFORATED | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| SPONDYLITIC MYELOPATHY | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 15.1 | Systematic Assessment |
|
| SYRINGOMYELIA | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
|
| BLEPHARITIS | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| CHALAZION | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| CONJUNCTIVITIS | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| DRY EYE | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| OCULAR HYPERAEMIA | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| VITREOUS FLOATERS | Eye disorders | MedDRA 15.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| CHEILITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| DENTAL CARIES | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| GASTRIC POLYPS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| HAEMORRHOIDS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| IRRITABLE BOWEL SYNDROME | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| ORAL DISORDER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| PALATAL OEDEMA | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| PROCTITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| SMALL INTESTINE ULCER | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| STOMATITIS | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| FOREIGN BODY REACTION | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| GRANULOMA | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| HEPATIC FUNCTION ABNORMAL | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| HEPATIC STEATOSIS | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| LIVER DISORDER | Hepatobiliary disorders | MedDRA 15.1 | Systematic Assessment |
|
| BEHCET'S SYNDROME | Immune system disorders | MedDRA 15.1 | Systematic Assessment |
|
| ACUTE TONSILLITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| BACTERIAL INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| CAMPYLOBACTER INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| CYSTITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| ENTERITIS INFECTIOUS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| FURUNCLE | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| GASTROENTERITIS VIRAL | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| GINGIVITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| HORDEOLUM | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| ORAL HERPES | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| OTITIS MEDIA | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| PHARYNGITIS | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| TINEA INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| TINEA VERSICOLOUR | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| ARTHROPOD STING | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| CONTUSION | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| LIGAMENT SPRAIN | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| ANTINUCLEAR ANTIBODY INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| BLOOD CREATINE PHOSPHOKINASE INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| CARCINOEMBRYONIC ANTIGEN INCREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| LIVER FUNCTION TEST ABNORMAL | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| MYCOBACTERIUM TUBERCULOSIS COMPLEX TEST POSITIVE | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| WHITE BLOOD CELL COUNT DECREASED | Investigations | MedDRA 15.1 | Systematic Assessment |
|
| DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| HYPERURICAEMIA | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| OBESITY | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| PERIARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| SPINAL OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| BENIGN NEOPLASM OF THYROID GLAND | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| COLON ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| LIPOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| RECTAL ADENOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| HYPOAESTHESIA | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| LACUNAR INFARCTION | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| AFFECTIVE DISORDER | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 15.1 | Systematic Assessment |
|
| HYPERTONIC BLADDER | Renal and urinary disorders | MedDRA 15.1 | Systematic Assessment |
|
| DYSMENORRHOEA | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| PROSTATIC CYST | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| UTERINE POLYP | Reproductive system and breast disorders | MedDRA 15.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| DYSPHONIA | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| RHINITIS ALLERGIC | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| ACNE | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| DERMATITIS | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| ECZEMA NUMMULAR | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| PAPULE | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| SKIN MASS | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 15.1 | Systematic Assessment |
|
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.
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| Title | Measurements |
|---|---|
|
| Week 52: Grade 0 |
|
| Week 52: Grade ≤1 |
|
| Week 52: Improvement of ≥1 Grade |
|
| Title | Measurements |
|---|---|
|
| Week 52: Grade 0 |
|
| Week 52: Grade ≤1 |
|
| Week 52: Grade ≤2 |
|
| Title | Measurements |
|---|---|
|
| Week 24:Abdominal Pain Improvement ≥1 Grade; n=18 |
|
| Week 24: Diarrhea Improvement ≥1 Grade; n=16 |
|
| Week 24:Other GI Symptom Improvement ≥1 Grade;n=20 |
|
| Week 52: Abdominal Pain Grade ≤1; n=18 |
|
| Week 52: Diarrhea Grade ≤1; n=16 |
|
| Week 52: Other GI Symptom Grade ≤1; n=20 |
|
| Week 52:Abdominal Pain Improvement ≥1 Grade; n=18 |
|
| Week 52: Diarrhea Improvement ≥1 Grade; n=16 |
|
| Week 52:Other GI Symptom Improvement ≥1 Grade;n=20 |
|
| Title | Measurements |
|---|---|
|
| Week 24: Vulval (Genital) Ulcer; n=3 |
|
| Week 52: Oral Aphthous; n=15 |
|
| Week 52: Skin (Erythema nodosum rash); n=8 |
|
| Week 52: Eye (Uveitis); n=0 |
|
| Week 52: Vulval (Genital) Ulcer; n=3 |
|
|
| Week 52: Summary Score (Mental Component) |
|