N/A
N=1,013
Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA
Moderate-to-severe Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01117480 ↗Enrolled (actual)
1,013
Serious AEs
4.4%
Results posted
Feb 2016
Primary outcome: Primary: Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 — 11; 13; 16; 15 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 |
11; 13; 16; 15; 16 | — |
| SECONDARY Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) |
1.39; -0.31; -0.34; -0.37; -0.37 | — |
| SECONDARY Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) |
5.4; -1.55; -1.77; -1.88; -1.93 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01117480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.