Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA

NCT ID: NCT01117480

Last Updated: 2016-02-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1013 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-07-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Moderate-to-severe Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate-to-severe rheumatoid arthritis

Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Linda Assouline, PhD

Role: STUDY_DIRECTOR

AbbVie Corporation

Related Links

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Other Identifiers

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PMOS-CANA-04-01

Identifier Type: -

Identifier Source: org_study_id

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