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

AbbVie

Status: Completed

Conditions: Moderate-to-severe Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01117480

PMOS-CANA-04-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,013 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,013 participants in 1 patient group

Moderate-to-severe rheumatoid arthritis

Description:

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