Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

552 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-05-31

Brief Summary

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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® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the drug for the treatment of rheumatoid arthritis.

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Detailed Description

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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 adalimumab by the Japanese regulatory authority, this post-marketing observational study (PMOS) was conducted. The study investigated the long-term safety of adalimumab, particularly associated with the development of infections and malignant tumors. Data was collected once every 6 months up to 3 years.

Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Adalimumab 40 mg/0.8 mL syringe for subcutaneous injection

Participants with rheumatoid arthritis who received adalimumab, per approved label

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Participants who received adalimumab in accordance with its indications for treatment and dosage regimens.
2. Participants who used adalimumab continuously.
3. Participants without current or past history of malignant tumors.
4. Participants evaluated for Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR).
5. 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

1. Contraindications according to the package insert.
2. Participants with serious infections.
3. Participants with tuberculosis.
4. Participants with a history of hypersensitivity to any ingredient of adalimumab.
5. Participants with demyelinating disease or a history of demyelinating disease.
6. Participants with congestive cardiac failure.

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No