Surveillance of Humira Injection in Korean Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01083121
Recruitment Status : Completed
First Posted : March 9, 2010
Results First Posted : August 20, 2013
Last Update Posted : August 21, 2013
Eisai Co., Ltd.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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.

Condition or disease
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Crohn's Disease Psoriasis

Study Type : Observational
Actual Enrollment : 1779 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Humira Injection in Korean Patients Under the "New-Drug Re-examination"
Study Start Date : April 2007
Primary Completion Date : June 2012
Study Completion Date : June 2012

Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.

Primary Outcome Measures :
  1. Number of Participants With Adverse Events (AEs) [ Time Frame: From Baseline until up to 70 days after the 3 month study period (total of 160 days). ]
    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.

Secondary Outcome Measures :
  1. Physician's Global Assessment for Effectiveness [ Time Frame: After 3-month treatment ]
    The investigator's overall assessment for effectiveness was recorded as 'Improved', 'No change', 'Aggravated,' or 'Not assessable'.

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinics, general hospitals

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01083121

  Show 77 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Eisai Co., Ltd.
Study Director: Deborah Chee, MD AbbVie Ltd.

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01083121     History of Changes
Other Study ID Numbers: P10-053
First Posted: March 9, 2010    Key Record Dates
Results First Posted: August 20, 2013
Last Update Posted: August 21, 2013
Last Verified: August 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Postmarketing Drug Surveillance

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Crohn Disease
Spondylitis, Ankylosing
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Anti-Inflammatory Agents
Antirheumatic Agents