Rheumatoid ArthritisNCT03109470
The Durability of Early RA Disease Control After Tocilizumab Withdrawal: A Canadian Experience
An observational study of Rheumatoid Arthritis, run by Pope Research Corporation.
Trial summary
Patients who participated in the FUNCTION Study (Protocol WA19926) will be enrolled in this study. The investigators want to learn how long it takes Early Rheumatoid Arthritis patients who were treated with Tocilizumab to require treatment with another biologic medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients withdrawing first-line tocilizumab and/or methotrexate therapy due to therapeutic response during the FUNCTION (WA19926) study that have agreed to provide informed consent will be enrolled in this study.
Who may be able to join
- Completed 2 years in the FUNCTION (WA19926) trial
- Patient has provided written informed consent and is willing to comply with the requirements of this study protocol
Who cannot join
- Requirement for immediate treatment with a biologic therapy following completion of the FUNCTION (WA19926) trial as per treating physician judgement.
- Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of RA
About this study
Patients who participated in the FUNCTION Study (Protocol WA19926) will be enrolled in this study. The investigators want to learn how long it takes Early Rheumatoid Arthritis patients who were treated with Tocilizumab to require treatment with another biologic medication.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Tocilizumab, Early Rheumatoid Arthritis, Observational, Canadian
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Biologic Treatment
To describe the rate of requiring biologic treatment over 2 years following completion of the FUNCTION study
Measured: 2 years
Secondary outcomes (5)
Treatment after completion of FUNCTION study
To determine the type of RA treatment regimen used by the treating physician upon completion of the FUNCTION study
Measured: Baseline
Rate of requiring treatment intensification
To determine the rate of requiring treatment intensification with a traditional DMARD(s) completion of the FUNCTION study. The durability of response after completion of the FUNCTION study. The clinical measures of disease progression over 2 years after completion of the FUNCTION study. The clinical measures of disease progression over 2 years after completion of the FUNCTION study.
Measured: 2 years
Change in functional status
The change in patient-reported functional status over 2 years after tocilizumab withdrawal or maintaining Mtx or changing DMARD(s)
Measured: 2 years
Work productivity
To determine work productivity over 2 years after completion of the FUNCTION study
Measured: 2 years
Healthcare Utilization
To determine health-care utilization over 2 years after completion of the FUNCTION study
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study startNov 2012
- Primary completionNov 2014
- Study completionNov 2014
Why it stopped: Insufficient enrollment potential
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pope Research Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Janet E Pope, MD, MPH, FRCPC, Principal investigator, Pope Research Corp.John S Sampalis, BSc, BA, MSc, PHD, FACE, Principal investigator, JSS Medical Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03109470
- Sponsor's protocol ID
- PRC-03-2012
- Status last verified
- Nov 2013
- First submitted
- 13 Nov 2013
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Durability of Early RA Disease Control After Tocilizumab Withdrawal: A Canadian Experience
- ClinicalTrials.gov ID
- NCT03109470
- Acronym / sponsor ID
- PRC-03-2012
- Conditions
- Rheumatoid Arthritis
- Keywords
- Tocilizumab, Early Rheumatoid Arthritis, Observational, Canadian
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Insufficient enrollment potential
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Pope Research CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Hoffmann-La Roche
- Study start
- Nov 2012 (actual)
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients who participated in the FUNCTION Study (Protocol WA19926) will be enrolled in this study. The investigators want to learn how long it takes Early Rheumatoid Arthritis patients who were treated with Tocilizumab to require treatment with another biologic medication.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients withdrawing first-line tocilizumab and/or methotrexate therapy due to therapeutic response during the FUNCTION (WA19926) study that have agreed to provide informed consent will be enrolled in this study.
Key inclusion criteria (2 listed)
- Completed 2 years in the FUNCTION (WA19926) trial
- Patient has provided written informed consent and is willing to comply with the requirements of this study protocol
Key exclusion criteria (2 listed)
- Requirement for immediate treatment with a biologic therapy following completion of the FUNCTION (WA19926) trial as per treating physician judgement.
- Presence of any condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of RA
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
Rate of Biologic Treatment
Time frame: 2 years
To describe the rate of requiring biologic treatment over 2 years following completion of the FUNCTION study
5 secondary outcomes
Treatment after completion of FUNCTION study
Time frame: Baseline
Rate of requiring treatment intensification
Time frame: 2 years
Change in functional status
Time frame: 2 years
Work productivity
Time frame: 2 years
Healthcare Utilization
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
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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.
Janet E Pope, MD, MPH, FRCPC principal investigator
Pope Research Corp.
John S Sampalis, BSc, BA, MSc, PHD, FACE principal investigator
JSS Medical Research Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Pope Research Corporation.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Apr 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Rate of Biologic Treatment (time frame: 2 years). 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 13 Apr 2017.