Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
|ClinicalTrials.gov Identifier: NCT01117480|
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
|Condition or disease|
|Moderate-to-severe Rheumatoid Arthritis|
|Study Type :||Observational|
|Actual Enrollment :||1013 participants|
|Official Title:||Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)|
|Study Start Date :||July 2005|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Moderate-to-severe rheumatoid arthritis
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
- Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 [ Time Frame: Month 0, 6, 12, 18 and 24 ]The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
- Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) [ Time Frame: Month 0, 6, 12, 18 and 24 ]Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 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 ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
- Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) [ Time Frame: Month 0, 6, 12, 18 and 24 ]The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 3 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01117480
|Study Director:||Linda Assouline, PhD||AbbVie Corporation|