Special Investigation of Humira® (Adalimumab) on Long-term Treatment in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01163318|
Recruitment Status : Completed
First Posted : July 15, 2010
Results First Posted : June 10, 2015
Last Update Posted : June 10, 2015
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||552 participants|
|Official Title:||Special Investigation (Long-term Treatment in Patients With Rheumatoid Arthritis)|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Adalimumab 40 mg/0.8 mL syringe for subcutaneous injection
Participants with rheumatoid arthritis who received adalimumab, per approved label
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01163318
|Study Director:||Sarina Kurimoto||AbbVie GK|