Surveillance of Humira Injection in Korean Patients

This study has been completed.

Sponsor:

Collaborator:

Eisai Co., Ltd.

Information provided by (Responsible Party):

AbbVie ( AbbVie (prior sponsor, Abbott) )

ClinicalTrials.gov Identifier:

NCT01083121

First received: February 24, 2010

Last updated: January 2, 2013

Last verified: January 2013

History of Changes

Purpose

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 and adverse events will be recorded on case report forms.

Condition	Intervention
Rheumatoid Arthritis Psoriatic Arthritis Ankylosing Spondylitis Crohn's Disease Psoriasis	Drug: adalimumab (Humira)

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Post-Marketing Surveillance of Humira Injection in Korean Patients Under the New-Drug Re-examination

Resource links provided by NLM:

Genetics Home Reference related topics: ankylosing spondylitis Crohn disease psoriatic arthritis

MedlinePlus related topics: Ankylosing Spondylitis Crohn's Disease Psoriasis Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

Adverse events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Physician's global assessment for effectiveness [ Time Frame: After 3-month treatment ] [ Designated as safety issue: No ]

Enrollment:	1698
Study Start Date:	April 2007
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Rheumatoid Arthritis Those with a condition	Drug: adalimumab (Humira) 40mg pre-filled syringe SC, once every 2 weeks Patients treated with adalimumab as per approved local product label and medical practice in Korea. Other Name: adalimumab Humira
Psoriatic Arthritis Those with a condition	Drug: adalimumab (Humira) 40mg pre-filled syringe SC, once every 2 weeks Patients treated with adalimumab as per approved local product label and medical practice in Korea. Other Name: adalimumab Humira
Ankylosing Spondylitis Those with a condition	Drug: adalimumab (Humira) 40mg pre-filled syringe SC, once every 2 weeks Patients treated with adalimumab as per approved local product label and medical practice in Korea. Other Name: adalimumab Humira
Crohn's Disease Those with a condition	Drug: adalimumab (Humira) 40mg pre-filled syringe SC, once every 2 weeks Patients treated with adalimumab as per approved local product label and medical practice in Korea. Other Name: adalimumab Humira
Psoriasis Those with a condition	Drug: adalimumab (Humira) 40mg pre-filled syringe SC, once every 2 weeks Patients treated with adalimumab as per approved local product label and medical practice in Korea. Other Name: adalimumab Humira

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Primary care clinics, general hospitals

Criteria

Inclusion Criteria

Adult patients (19 years and above) with 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 PUVA (photochemotherapy).
Patients who give verbal or written authorization to use their personal and health data

Exclusion Criteria

1. Patients with known hypersensitivity to adalimumab or any of its excipients

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083121

Show 77 Study Locations

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Eisai Co., Ltd.

Investigators

Study Director:

Deborah Chee, MD

AbbVie Ltd.

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01083121 History of Changes
Other Study ID Numbers:	P10-053
Study First Received:	February 24, 2010
Last Updated:	January 2, 2013
Health Authority:	Korea: Food and Drug Administration

Keywords provided by AbbVie:

Postmarketing Drug Surveillance

Additional relevant MeSH terms:

Arthritis
Arthritis, Psoriatic
Arthritis, Rheumatoid
Crohn Disease
Psoriasis
Spondylitis
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases

Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Bone Diseases, Infectious
Infection
Ankylosis
Adalimumab
Antirheumatic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013

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