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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01163318
• Other study ID #: P12-070
• Status: Completed
• Phase: N/A
• First received: July 14, 2010
• Last updated: May 28, 2015
• Start date: December 2009
• Est. completion date: May 2014

Study information

• Verified date: May 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 552
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Drug Reactions (ADRs)	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.	From the initiation of adalimumab treatment, every 6 months up to 3 years.	Yes
Secondary	Incidence of Infections and Malignant Tumors	Participants were evaluated for the presence/absence of malignant tumors and infections. Data are presented as percentage of participants.	From the initiation of adalimumab treatment, every 6 months up to 3 years.	Yes
Secondary	Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit	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.	Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3	No
Secondary	Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score = 0.5 by Visit	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.	Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3	No

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