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

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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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Incidence of Adverse Drug Reactions (ADRs)

Time frame: From the initiation of adalimumab treatment, every 6 months up to 3 years.

An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.

Secondary outcomes

Incidence of Infections and Malignant Tumors

Time frame: From the initiation of adalimumab treatment, every 6 months up to 3 years.

Participants were evaluated for the presence/absence of malignant tumors and infections. Data are presented as percentage of participants.
Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit

Time frame: Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3

DAS28-4ESR, a combined index that measured activity of rheumatoid arthritis, was calculated based on: (1) the number of tender joints among 28 joints evaluated; (2) the number of swollen joints among 28 joints evaluated; (3) general health evaluated by a visual analog scale (VAS); and (4) ESR. DAS28-4ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity); decrease in DAS28-4ESR scores indicate improvement of disease. DAS28-4ESR score < 2.6 was defined as clinical remission of rheumatoid arthritis. Data are presented as percentage of participants.
Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit

Time frame: Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3

MHAQ was a participant-reported questionnaire that measured quality of life in terms of physical function of participants with rheumatic diseases. Participants assessed their ability to do each task over the past 6 months using the following response categories (score): without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score from 0 to 3, where 0 represented no disability and 3 very severe, high-dependency disability. MHAQ score ≤ 0.5 was defined as clinical remission, signifying normal physical function. Data are presented as percentage of participants.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study title

Special Investigation (Long-term Treatment in Patients With Rheumatoid Arthritis)

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Jul 15, 2010
Registry last updated: Jun 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed