Clinical trial NCT01117480: Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA
Official title: Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Moderate-to-severe Rheumatoid Arthritis
Keywords: Moderate Rheumatoid Arthritis
Rheumatoid Arthritis
Severe Rheumatoid Arthritis
Adalimumab
Clinical Effectiveness
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
Collaborators: name: University Health Network, Toronto
First posted: 2010-05-05
Enrollment: 1013
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with moderate-to-severe rheumatoid arthritis

Brief summary: The purpose of this study is to evaluate the clinical effectiveness and safety of adalimumab as used in routine clinical practice in adult participants with moderate to severe rheumatoid arthritis (RA) in Canada.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
timeFrame: Month 0, 6, 12, 18 and 24
Secondary outcomes:
measure: Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
timeFrame: Month 0, 6, 12, 18 and 24
measure: Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
timeFrame: Month 0, 6, 12, 18 and 24
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie Corporation
name: Linda Assouline, PhD
role: STUDY_DIRECTOR
References: