Real Life Evaluation of Rheumatoid Arth… | Clinical Trial

Key information

Conditions

Moderate-to-severe 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

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

REACH is an observational survey of participants with moderate to severe rheumatoid arthritis taking adalimumab. Participants who volunteer will be asked to provide information about their medical history and experiences with adalimumab. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Participant is eligible to take part in the registry as per the product monograph.
Participants that are naïve to adalimumab therapy / or participants that have been receiving adalimumab therapy for less than 4 months.
Participant has moderately to severely active RA.
Participant who has had an inadequate response to one or more Disease Modifying Anti-Rheumatic Drugs (DMARDs).
Participant received provincial or private (insurance companies) approval for adalimumab.
Participant is able to give written informed consent and to understand the survey requirements.

Exclusion criteria

Participant to whom a traditional DMARD had never been tried.
Participant with a known hypersensitivity to adalimumab, or any of its components.
Participant is receiving free adalimumab as part of a compassionate program or an early access drug distribution program.
Participant with clinically significant concurrent medical or psychiatric disorders that may influence survey outcomes.
Participant with any condition that would prevent participation in the survey and completion of the survey procedures including language limitation or possibility that the participant will not be available for a period of time (> 12 months) while being enrolled in the survey.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Collaborators

University Health Network, Toronto

Registry information

Official study title

Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)

Acronym: REACH

Important dates

Study start: 2005
Primary completion: 2014
Study completion: 2014
First posted: May 5, 2010
Registry last updated: Feb 24, 2016

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