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| Name | Class |
|---|---|
| Abbott Japan Co.,Ltd | INDUSTRY |
| Eisai Co., Ltd. | INDUSTRY |
The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the induction of clinical remission in Japanese subjects with Crohn's disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab 160 mg/80 mg | Experimental |
| |
| Adalimumab 80 mg/40 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adalimumab | Biological | 160 mg at Week 0, 80 mg at Week 2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 | CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4. | 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission (CDAI < 150) at Week 2 | Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2. | Week 2 |
| Clinical Response (CR-70 and CR-100) in Period A |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Morio Ozawa | Abbott Japan Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22325170 | Derived | Watanabe M, Hibi T, Lomax KG, Paulson SK, Chao J, Alam MS, Camez A; Study Investigators. Adalimumab for the induction and maintenance of clinical remission in Japanese patients with Crohn's disease. J Crohns Colitis. 2012 Mar;6(2):160-73. doi: 10.1016/j.crohns.2011.07.013. Epub 2011 Aug 26. |
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All subjects were evaluated at Week 4. If responders (CDAI decrease >= 70 points compared to Baseline), rolled over to a maintenance study. If non-responders (CDAI decrease of < 70 points compared to Baseline), continued in study and received: adalimumab 160/80 mg + 40/40 mg, or adalimumab 80/40 mg + 40/40 mg or placebo + adalimumab 160/80 mg.
Subjects with moderate to severe Crohn's Disease (Crohn's Disease Activity Index [CDAI] >= 220 and <= 450) were enrolled into study. The period from the first dose of study drug to the evaluation at Week 4 is Period A. The period from the study drug injection at Week 4 to the evaluation at Week 8 is Period B.
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab 160 mg/80 mg | Adalimumab 160 mg at Week 0, 80 mg at Week 2 |
| FG001 | Adalimumab 80 mg/40 mg | Adalimumab 80 mg at Week 0, 40 mg at Week 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period A - Week 0 - Week 4 |
|
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| adalimumab | Biological | 80 mg at Week 0, 40 mg at Week 2 |
|
|
| placebo | Biological | Placebo at Week 0 and Week 2 |
|
The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4. |
| Weeks 2 and Week 4 |
| Clinical Response (CR-70 and CR-100) in Period B | The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8. | Week 6 and Week 8 |
| Clinical Remission (CDAI <150) at Week 6 and Week 8 | The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8 | Week 6 and Week 8 |
| Chiba |
| Japan |
| Ehime | Japan |
| Fukuoka | Japan |
| Hiroshima | Japan |
| Hokkaido | Japan |
| Hyōgo | Japan |
| Kagawa | Japan |
| Kanagawa | Japan |
| Kochi | Japan |
| Kyoto | Japan |
| Miyagi | Japan |
| Okayama | Japan |
| Okinawa | Japan |
| Osaka | Japan |
| Shiga | Japan |
| Shizuoka | Japan |
| Tokyo | Japan |
| FG002 | Placebo | Placebo at Week 0, placebo at Week 2 |
| FG003 | Adalimumab 40mg /40 mg | Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6. |
| COMPLETED |
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| NOT COMPLETED |
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| Period B - Week 4 - Week 8 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab 160 mg/80 mg | Adalimumab 160 mg at Week 0, 80 mg at Week 2 |
| BG001 | Adalimumab 80 mg/40 mg | Adalimumab 80 mg at Week 0, 40 mg at Week 2 |
| BG002 | Placebo | Placebo at Week 0, placebo Week 2 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Gender, Male/Female who received first dose of study drug | Count of Participants | Participants |
| |||||||||||||||
| Region of Enrollment | Number | participants |
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| 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 | The Number of Subjects With a Clinical Remission (Crohn's Disease Activity Index [CDAI] < 150) at Week 4 | CDAI is used to quantify the symptoms of patients with Crohn's Disease. A score below 150 indicates remission and a score above 450 indicates severe disease. Comparison of the number of subjects with a clinical remission (CDAI < 150) in the adalimumab 160 mg (Week 0)/ 80 mg (Week 2) and adalimumab 80 mg (Week 0)/ 40 mg (Week 2) groups at Week 4. | The primary analysis will be performed on the full analysis set (randomized subjects who received at least one dose of study drug) using the non-responder imputation for missing remission observations. | Posted | Number | Particpants | 4 Weeks |
|
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| ||||||||||||||||||||||||||||||||
| Secondary | Clinical Remission (CDAI < 150) at Week 2 | Number of subjects in each treatment group in clinical remission (CDAI < 150) in Full Analysis Set (FAS) using non-responder Imputation (NRI) at Week 2. | Subjects with a clinical remission (CDAI <= 150) in the adalimumab 160 mg (Week 0/80 mg (Week 2) and adalimumab 80 mg (Week 0)/40 mg (Week 2) in full analysis set using Non-responder Imputation. | Posted | Number | Participants | Week 2 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Clinical Response (CR-70 and CR-100) in Period A | The number of subjects in each treatment group with a clinical response 70 (CDAI decrease of >=70 compared to Baseline) and 100 (CDAI decrease of >=100 compared to Baseline) at Week 2 and Week 4. | The secondary efficacy analysis was performed using descriptive statistics in randomized subjects who received at least one dose of study drug (full analysis set) in the three treatment groups: Adalimumab 160 mg/80 mg, adalimumab 80mg/40 mg, and placebo. | Posted | Number | participants | Weeks 2 and Week 4 |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Clinical Response (CR-70 and CR-100) in Period B | The Number of subjects in each treatment group with a CR-70 (CDAI decrease of >= 70 compared to Baseline) and 100 (CDAI decrease of >= 100 compared to Baseline) in subjects who were non-responders at Week 4 at Week 6 and Week 8. | Full analysis set - subjects rated as non-responders (did not attain CDAI reduction >= 70) in the evaluation of CR-70 and CR-100 at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + 160/80 mg. | Posted | Number | Participants | Week 6 and Week 8 |
| ||||||||||||||||||||||||||||||||||
| Secondary | Clinical Remission (CDAI <150) at Week 6 and Week 8 | The number of subjects with clinical remission (CDAI < 150) in the subjects who were non-responders at Week 4 calculated with non-responder imputation (NRI) at Week 6 and Week 8 | Subjects who were rated as non-responders (CDAI reduction < 70) in the evaluation of clinical remission (CDAI<150) at Week 4. For Week 6 and Week 8 descriptive statistics performed only for non-responders at Week 4 in the three treatment groups: adalimumab 160/80 mg + 40/40 mg, adalimumab 80/40 mg + 40/40 mg, and placebo + adalimumab 160/80 mg. | Posted | Number | Participants | Week 6 and Week 8 |
|
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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 | Adaliumab 160 mg/80 mg | Adalimumab 160 mg at Week 0, 80 mg at Week 2 | 1 | 12 | ||||
| EG001 | Adalimumab 80 mg/40 mg | Adalimumab 80 mg at Week 0, 40 mg at Week 2 | 3 | 15 | ||||
| EG002 | Placebo | Placebo at Week 0, placebo at Week 2 | 2 | 8 | ||||
| EG003 | Adalimumab 160 mg/80 mg + 40/40 mg | Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6 | 1 | 5 | ||||
| EG004 | 80/40 mg + 40/40 mg | Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6 | 1 | 9 | ||||
| EG005 | Placebo + Adalimumab 160/80 mg | Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6 | 0 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal abcess | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| C-reactive protein increased (at investigator's discretion) | Investigations | MedDrA 9.1 | Systematic Assessment |
| |
| Crohn's Disease | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Epididymitis | Reproductive system and breast disorders | MedDrA 9.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Antinuclear antibody increased (at investigator's discretion) | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Application site swelling | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Blood albumin decreased (at investigator's discretion) | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase (at investigator's discretion) | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Blood glucose increased (at investigator's discretion) | Investigations | MedDRA 9.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Feeling abnormal | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Glucose tolerance impaired (at investigator's discretion) | Metabolism and nutrition disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MeddRA 9.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Herpes Simplex | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Injection site reaction | General disorders | Meddra 9.1 | Non-systematic Assessment |
| |
| Instillation site pain | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 9.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRa 9.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 9.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 9.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 9.1 | Non-systematic Assessment |
|
Small population, therefore no statistical tests were performed
Disclosure agreements vary; most restrictive agreement states Medical Institution shall not disclose materials/information disclosed by Abbott Japan in connection with the Clinical Research, or information obtained by conducting the Clinical Research, to third parties without Abbott Japan's prior written approval. When Medical Institution intends to publish information obtained by conducting the Clinical Research, Medical Institution shall obtain Abbott Japan's prior written approval.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
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| Units | Counts |
|---|---|
| Participants |
|
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| Units | Counts |
|---|
| Participants |
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