Moderate-to-severe Rheumatoid ArthritisREACHNCT01117480
Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA
An observational study of Moderate-to-severe Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate-to-severe Rheumatoid Arthritis
- How many people
- 1,013 participants
- Where
- No sites listed yet
- Study dates
- Jul 2005to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with moderate-to-severe rheumatoid arthritis
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
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.
Read the 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.
- Conditions
- Moderate-to-severe Rheumatoid Arthritis
- Keywords
- Moderate Rheumatoid Arthritis, Rheumatoid Arthritis, Severe Rheumatoid Arthritis, Adalimumab, Clinical Effectiveness
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-severe rheumatoid arthritis | Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
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.
Measured: Month 0, 6, 12, 18 and 24
Secondary outcomes (2)
Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
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.
Measured: Month 0, 6, 12, 18 and 24
Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
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.
Measured: Month 0, 6, 12, 18 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startJul 2005
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Moderate-to-severe Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,013 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Linda Assouline, PhD, Study director, AbbVie Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01117480
- Sponsor's protocol ID
- PMOS-CANA-04-01
- Acronym
- REACH
- Status last verified
- Jan 2016
- First submitted
- 4 May 2010
- Last updated
- 24 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
- ClinicalTrials.gov ID
- NCT01117480
- Acronym / sponsor ID
- REACH / PMOS-CANA-04-01
- Conditions
- Moderate-to-severe Rheumatoid Arthritis
- Keywords
- Moderate Rheumatoid Arthritis, Rheumatoid Arthritis, Severe Rheumatoid Arthritis, Adalimumab, Clinical Effectiveness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,013 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Collaborators
- University Health Network, Toronto
- Study start
- Jul 2005
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 May 2010 (estimated)
- Results
- Posted 24 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-severe rheumatoid arthritis | – | –Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with moderate-to-severe rheumatoid arthritis
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
Time frame: Month 0, 6, 12, 18 and 24
Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
Time frame: Month 0, 6, 12, 18 and 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Assouline, PhD study director
AbbVie Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Moderate-to-severe Rheumatoid Arthritis, run by AbbVie (prior sponsor, Abbott).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 (time frame: Month 0, 6, 12, 18 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.