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| Name | Class |
|---|---|
| Eisai Co., Ltd. | INDUSTRY |
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Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of Humira. Information on demographics, diagnosis and medical history, results of tuberculosis skin test, results of chest X-ray, Humira treatment information, concomitant medication, physician's global assessment for effectiveness, disease activity assessment for rheumatoid arthritis, disease activity assessment for Crohn's Disease, disease activity assessment for Psoriasis and adverse events will be recorded on case report forms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information. | From Baseline until up to 70 days after the 3 month study period (total of 160 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment for Effectiveness | The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'. | After 3-month treatment |
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Inclusion Criteria:
Adult patients (19 years and above) with one of the following indications:
Patients who give verbal or written authorization to use their personal and health data.
Exclusion Criteria:
- Patients with known hypersensitivity to adalimumab or any of its excipients.
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Primary care clinics, general hospitals
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| Name | Affiliation | Role |
|---|---|---|
| Deborah Chee, MD | AbbVie Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 29724 | Ansan | 152-703 | South Korea | |||
| Site Reference ID/Investigator# 53586 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Ansan |
| 152-703 |
| South Korea |
| Site Reference ID/Investigator# 29729 | Bucheon-si | 420-767 | South Korea |
| Site Reference ID/Investigator# 29009 | Bucheon-si | 420-818 | South Korea |
| Site Reference ID/Investigator# 29726 | Busan | 602-715 | South Korea |
| Site Reference ID/Investigator# 29733 | Busan | 602-739 | South Korea |
| Site Reference ID/Investigator# 28582 | Busan | 608-838 | South Korea |
| Site Reference ID/Investigator# 5633 | Busan | 611-072 | South Korea |
| Site Reference ID/Investigator# 28608 | Cheonan | 330-715 | South Korea |
| Site Reference ID/Investigator# 28996 | Cheonan | 330-721 | South Korea |
| Site Reference ID/Investigator# 29735 | Daegu | 700-712 | South Korea |
| Site Reference ID/Investigator# 59287 | Daegu | 705-717 | South Korea |
| Site Reference ID/Investigator# 29278 | Daegu | 705-718 | South Korea |
| Site Reference ID/Investigator# 29279 | Daegu | 705-718 | South Korea |
| Site Reference ID/Investigator# 29007 | Daejeon | 301-808 | South Korea |
| Site Reference ID/Investigator# 29727 | Daejeon | 302-799 | South Korea |
| Site Reference ID/Investigator# 29745 | Daejeon | 302-799 | South Korea |
| Site Reference ID/Investigator# 48624 | Daejeon | 302-799 | South Korea |
| Site Reference ID/Investigator# 29075 | Goyang | 411-706 | South Korea |
| Site Reference ID/Investigator# 29042 | Guri-si | 471-701 | South Korea |
| Site Reference ID/Investigator# 59285 | Guri-si | 471-701 | South Korea |
| Site Reference ID/Investigator# 29731 | Gwangju | 501-717 | South Korea |
| Site Reference ID/Investigator# 81693 | Gwangju | 501-717 | South Korea |
| Site Reference ID/Investigator# 29732 | Gwangju | 501-757 | South Korea |
| Site Reference ID/Investigator# 29737 | Gwangju | 501-757 | South Korea |
| Site Reference ID/Investigator# 29742 | Gwangju | 501-757 | South Korea |
| Site Reference ID/Investigator# 28611 | Gyeongju | 780-350 | South Korea |
| Site Reference ID/Investigator# 29103 | Iksan | 570-711 | South Korea |
| Site Reference ID/Investigator# 29010 | Incheon | 403-016 | South Korea |
| Site Reference ID/Investigator# 28589 | Jeju City | 690-766 | South Korea |
| Site Reference ID/Investigator# 29080 | Jeju City | 690-767 | South Korea |
| Site Reference ID/Investigator# 29743 | Jeollabuk-do | 651-180 | South Korea |
| Site Reference ID/Investigator# 29082 | Jeonju | 560-750 | South Korea |
| Site Reference ID/Investigator# 29740 | Jinju | 660-702 | South Korea |
| Site Reference ID/Investigator# 29172 | Masan | 630-522 | South Korea |
| Site Reference ID/Investigator# 29436 | Metropolitan City Daejon | 302-718 | South Korea |
| Site Reference ID/Investigator# 28970 | Pohang | 790-825 | South Korea |
| Site Reference ID/Investigator# 29723 | Seongnam | 463-712 | South Korea |
| Site Reference ID/Investigator# 29722 | Seongnam | 463-824 | South Korea |
| Site Reference ID/Investigator# 29738 | Seoul | 110-744 | South Korea |
| Site Reference ID/Investigator# 53584 | Seoul | 110-744 | South Korea |
| Site Reference ID/Investigator# 59283 | Seoul | 120-752 | South Korea |
| Site Reference ID/Investigator# 29452 | Seoul | 130-702 | South Korea |
| Site Reference ID/Investigator# 29453 | Seoul | 130-702 | South Korea |
| Site Reference ID/Investigator# 53583 | Seoul | 130-702 | South Korea |
| Site Reference ID/Investigator# 29728 | Seoul | 133-792 | South Korea |
| Site Reference ID/Investigator# 29734 | Seoul | 133-792 | South Korea |
| Site Reference ID/Investigator# 29721 | Seoul | 134-709 | South Korea |
| Site Reference ID/Investigator# 29029 | Seoul | 134-727 | South Korea |
| Site Reference ID/Investigator# 29736 | Seoul | 135-710 | South Korea |
| Site Reference ID/Investigator# 59282 | Seoul | 135-710 | South Korea |
| Site Reference ID/Investigator# 29741 | Seoul | 135-720 | South Korea |
| Site Reference ID/Investigator# 29165 | Seoul | 135-895 | South Korea |
| Site Reference ID/Investigator# 29166 | Seoul | 136-705 | South Korea |
| Site Reference ID/Investigator# 29011 | Seoul | 137-701 | South Korea |
| Site Reference ID/Investigator# 48623 | Seoul | 137-701 | South Korea |
| Site Reference ID/Investigator# 63322 | Seoul | 137-701 | South Korea |
| Site Reference ID/Investigator# 29748 | Seoul | 138-736 | South Korea |
| Site Reference ID/Investigator# 53582 | Seoul | 138-736 | South Korea |
| Site Reference ID/Investigator# 29076 | Seoul | 139-707 | South Korea |
| Site Reference ID/Investigator# 29034 | Seoul | 139-872 | South Korea |
| Site Reference ID/Investigator# 29434 | Seoul | 143-729 | South Korea |
| Site Reference ID/Investigator# 29435 | Seoul | 143-729 | South Korea |
| Site Reference ID/Investigator# 29744 | Seoul | 150-030 | South Korea |
| Site Reference ID/Investigator# 29041 | Seoul | 150-071 | South Korea |
| Site Reference ID/Investigator# 29012 | Seoul | 150-713 | South Korea |
| Site Reference ID/Investigator# 66654 | Seoul | 156-707 | South Korea |
| Site Reference ID/Investigator# 59284 | Seoul | 156-755 | South Korea |
| Site Reference ID/Investigator# 29035 | Seoul | 158-710 | South Korea |
| Site Reference ID/Investigator# 59286 | Seoul | 366-144 | South Korea |
| Site Reference ID/Investigator# 53588 | Suwon | 442-723 | South Korea |
| Site Reference ID/Investigator# 29746 | Suwon | 443-721 | South Korea |
| Site Reference ID/Investigator# 29739 | Taegu | South Korea |
| Site Reference ID/Investigator# 29085 | Uljeongbu | 480-824 | South Korea |
| Site Reference ID/Investigator# 28610 | Ulsan | 681-711 | South Korea |
| Site Reference ID/Investigator# 29725 | Ulsan | 682-714 | South Korea |
| Site Reference ID/Investigator# 29730 | Wŏnju | 220-701 | South Korea |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety analysis population
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea. |
| 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 | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Indication | Number | participants |
|
| 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 Adverse Events (AEs) | An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. An Adverse Drug Reaction (ADR) is any noxious and undesired reaction related to an experimental drug or experiment. A serious AE (SAE) is an AE that results in death, is life-threatening, results in or prolongs hospitalization, results in congenital anomaly, persistent or significant disability/incapacity, spontaneous or elective abortion, or requires intervention to prevent a serious outcome. AEs were rated for severity as either Mild: transient and easily tolerated; Moderate: causes discomfort and interrupts usual activities; or Severe: causes considerable interference with usual activities, may be incapacitating or life-threatening. AEs related to adalimumab were assessed as being either probably or possibly related by the investigator. An Unexpected ADR is an ADR for which the nature or gravity is not consistent with the applicable product information. | Safety analysis population | Posted | Number | participants | From Baseline until up to 70 days after the 3 month study period (total of 160 days). |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Physician's Global Assessment for Effectiveness | The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'. | Effectiveness evaluation was performed in 1,471 participants who received adalimumab for at least 3 months and in whom investigator's assessment at 3 months was available. No participants were available in the Psoriasis group for effectiveness evaluation. | Posted | Number | participants | After 3-month treatment |
|
For up to 70 days after the 3 month study period (total of 160 days).
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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 | Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea. | 47 | 1,698 | 0 | 1,698 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyelonephritis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Peritoneal tuberculosis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Renal tuberculosis | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Bursitis infective | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Malaria | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pneumonia cryptococcal | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Peritoneal abscess | Infections and infestations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Intestinal perforation | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Peritonitis | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Intestinal infarction | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Paralysis | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dementia | Nervous system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Ankylosing spondylitis | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.0) | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dislocation of vertebra | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA (14.0) | Non-systematic Assessment |
| |
| Pulmonary haemorrhage | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Knee operation | Surgical and medical procedures | MedDRA (14.0) | Non-systematic Assessment |
| |
| Small intestinal resection | Surgical and medical procedures | MedDRA (14.0) | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA (14.0) | Non-systematic Assessment |
| |
| Hepatotoxicity | Hepatobiliary disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Allergy to sting | Immune system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (14.0) | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (14.0) | Non-systematic Assessment |
|
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| D003424 | Crohn Disease |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| Ankylosing spondylitis |
|
| Crohn's disease |
|
| Psoriasis |
|
| Title | Measurements |
|---|---|
|
| Mild adverse event |
|
| Moderate adverse event |
|
| Severe adverse event |
|
| Discontinued adalimumab due to adverse event |
|
| Adverse events related to adalimumab |
|
| Unexpected adverse drug reaction |
|
| Crohn's Disease |
Participants with severely active Crohn's disease who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea. |
|
|