Status:
COMPLETED
Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
15+ years
Brief Summary
The purpose of this study was to collect data on the incidence of adverse drug reactions, infections and malignant tumors, as well as factors that might affect the safety and effectiveness of Humira® ...
Detailed Description
Rheumatoid arthritis is a chronic autoimmune disease which requires long-term treatment. Due to the need of long-term safety data in Japanese participants and to fulfil the conditions of approval of a...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.
- Participants who used adalimumab continuously.
- Participants without current or past history of malignant tumors.
- Participants evaluated for Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR).
- Participants evaluated by Health Assessment Questionnaire (HAQ) or Modified Health Assessment Questionnaire (MHAQ) prior to the initiation of adalimumab treatment in the all-case PMOS.
- Exclusion criteria:
- Contraindications according to the package insert.
- Participants with serious infections.
- Participants with tuberculosis.
- Participants with a history of hypersensitivity to any ingredient of adalimumab.
- Participants with demyelinating disease or a history of demyelinating disease.
- Participants with congestive cardiac failure.
Exclusion
Key Trial Info
Start Date :
December 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT01163318
Start Date
December 1 2009
End Date
May 1 2014
Last Update
June 10 2015
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