Rheumatoid Arthritis Clinical Trial
Official title:
Post-Marketing Surveillance of Humira Injection in Korean Patients Under the "New-Drug Re-examination"
| Verified date | August 2013 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Food and Drug Administration |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1779 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 19 Years and older |
| Eligibility |
Inclusion Criteria: - Adult patients (19 years and above) with one of the following indications: - Moderately to severely active rheumatoid arthritis or - active and progressive psoriatic arthritis when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate or - severe active ankylosing spondylitis who have had an inadequate response to conventional therapy or - severely active Crohn's disease who have had no response, intolerance or contraindication to corticosteroid therapy or immunosuppressants or - moderately to severely active psoriasis patients who have had no response, have intolerance or have contraindication to systemic therapies including cyclosporine, methotrexate or photochemotherapy (PUVA). - 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. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Site Reference ID/Investigator# 29724 | Ansan | |
| Korea, Republic of | Site Reference ID/Investigator# 53586 | Ansan | |
| Korea, Republic of | Site Reference ID/Investigator# 29009 | Bucheon | |
| Korea, Republic of | Site Reference ID/Investigator# 29729 | Bucheon | |
| Korea, Republic of | Site Reference ID/Investigator# 28582 | Busan | |
| Korea, Republic of | Site Reference ID/Investigator# 29726 | Busan | |
| Korea, Republic of | Site Reference ID/Investigator# 29733 | Busan | |
| Korea, Republic of | Site Reference ID/Investigator# 5633 | Busan | |
| Korea, Republic of | Site Reference ID/Investigator# 28608 | Cheonan | |
| Korea, Republic of | Site Reference ID/Investigator# 28996 | Cheonan | |
| Korea, Republic of | Site Reference ID/Investigator# 29278 | Daegu | |
| Korea, Republic of | Site Reference ID/Investigator# 29279 | Daegu | |
| Korea, Republic of | Site Reference ID/Investigator# 29735 | Daegu | |
| Korea, Republic of | Site Reference ID/Investigator# 59287 | Daegu | |
| Korea, Republic of | Site Reference ID/Investigator# 29007 | Daejeon | |
| Korea, Republic of | Site Reference ID/Investigator# 29727 | Daejeon | |
| Korea, Republic of | Site Reference ID/Investigator# 29745 | Daejeon | |
| Korea, Republic of | Site Reference ID/Investigator# 48624 | Daejeon | |
| Korea, Republic of | Site Reference ID/Investigator# 29075 | Goyang | |
| Korea, Republic of | Site Reference ID/Investigator# 29042 | Guri | |
| Korea, Republic of | Site Reference ID/Investigator# 59285 | Guri | |
| Korea, Republic of | Site Reference ID/Investigator# 29731 | Gwangju | |
| Korea, Republic of | Site Reference ID/Investigator# 29732 | Gwangju | |
| Korea, Republic of | Site Reference ID/Investigator# 29737 | Gwangju | |
| Korea, Republic of | Site Reference ID/Investigator# 29742 | Gwangju | |
| Korea, Republic of | Site Reference ID/Investigator# 81693 | Gwangju | |
| Korea, Republic of | Site Reference ID/Investigator# 28611 | Gyeongju | |
| Korea, Republic of | Site Reference ID/Investigator# 29103 | Iksan | |
| Korea, Republic of | Site Reference ID/Investigator# 29010 | Incheon | |
| Korea, Republic of | Site Reference ID/Investigator# 28589 | Jeju | |
| Korea, Republic of | Site Reference ID/Investigator# 29080 | Jeju | |
| Korea, Republic of | Site Reference ID/Investigator# 29743 | Jeollabuk-do | |
| Korea, Republic of | Site Reference ID/Investigator# 29082 | Jeonju | |
| Korea, Republic of | Site Reference ID/Investigator# 29740 | Jinju | |
| Korea, Republic of | Site Reference ID/Investigator# 29172 | Masan | |
| Korea, Republic of | Site Reference ID/Investigator# 29436 | Metropolitan city Daejon | |
| Korea, Republic of | Site Reference ID/Investigator# 28970 | Pohang | |
| Korea, Republic of | Site Reference ID/Investigator# 29722 | Seongnam | |
| Korea, Republic of | Site Reference ID/Investigator# 29723 | Seongnam | |
| Korea, Republic of | Site Reference ID/Investigator# 29011 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29012 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29029 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29034 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29035 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29041 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29076 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29165 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29166 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29434 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29435 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29452 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29453 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29721 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29728 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29734 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29736 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29738 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29741 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29744 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 29748 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 48623 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 53582 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 53583 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 53584 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 59282 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 59283 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 59284 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 59286 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 63322 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 66654 | Seoul | |
| Korea, Republic of | Site Reference ID/Investigator# 53588 | Suwon | |
| Korea, Republic of | Site Reference ID/Investigator# 29746 | Suwon-si | |
| Korea, Republic of | Site Reference ID/Investigator# 29739 | Taegu | |
| Korea, Republic of | Site Reference ID/Investigator# 29085 | Uljeongbu | |
| Korea, Republic of | Site Reference ID/Investigator# 28610 | Ulsan | |
| Korea, Republic of | Site Reference ID/Investigator# 29725 | Ulsan | |
| Korea, Republic of | Site Reference ID/Investigator# 29730 | Wonju |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) | Eisai Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | From Baseline until up to 70 days after the 3 month study period (total of 160 days). | Yes |
| Secondary | 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 | No |
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