Rheumatoid ArthritisPhase 4NCT02109289
Etanercept in Rheumatoid Arthritis and Vascular Inflammation
A Phase 4 study testing etanercept in people with Rheumatoid Arthritis and Vascular Inflammation, run by Innovaderm Research Inc. at 1 site in Canada.
Trial summary
The primary goal of this preliminary project is to study the effect of etanercept, a medicine approved by Health Canada for the treatment of rheumatoid arthritis, on the inflammation of certain blood vessels. In particular, the inflammation of the aorta and the carotid arteries will be studied. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis, Vascular Inflammation
- What is being tested?
- etanercept
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Nov 2016
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is 18 to 80 years of age, inclusive.
- Patient's weight at screening is a maximum of 180 kg.
- Patient has a clinical diagnosis of active RA for at least 3 months defined as:
- 2-4 joints with active synovitis OR
- 1 joint with active synovitis and a high sensitivity C-reactive protein higher than the upper limit.
- Patient with active synovitis despite treatment for at least 3 months with a dose of methotrexate of at least 15 mg per week.
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- Patient is eligible to receive etanercept according to Canadian Product Monograph.
- Medications used to control angina, hypertension, serum lipids and any medication that can have an effect on inflammation must be on a stable dose for at least 8 weeks before baseline.
- Patient with an ascending aorta atherosclerotic plaque inflammation target-to-background ratio of 1.6 or more as determined by 18-FDG uptake measured by PET scanning at pre-enrolment.
- Female patients of childbearing potential must have a negative serum pregnancy test at the Screening visit.
- Unless patient or patient's partner is in a menopausal state for at least a year, surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation or vasectomy), clinically diagnosed infertile, having a same-sex partner or abstinent,female of childbearing potential or male patient (or his female partner of childbearing potential) is willing to use effective contraceptive method for at least 30 days before Day 0 and at least 4 weeks after the last study drug administration. Effective contraceptive methods are:
- Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream
- Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring. Oral contraceptives must have been taken at a stable dose for at least 90 days before study start
- Intrauterine device (IUD).
- If result not available in the last 6 months: Patient will be evaluated for latent TB infection with a PPD (Purified Protein Derivative (Mantoux test)) or a Quantiferon Gold test and CXR (chest x-ray).
- Patient who demonstrates evidence of latent TB infection defined below will not be allowed to participate in the study:
- Either PPD more than or equal to 5 mm of induration or positive Quantiferon Gold, irrespective of Bacillus Calmette-Guerin (BCG) vaccination AND/OR
- Clinically significant CXR findings or suspicious findings for active TB
- Patients with diabetes should be well controlled and have a fasting glucose below 11.1 mmol/L.
- Except for RA, patient is judged to be in good general health as determined by the principal investigator based upon the results of medical history, symptom directed physical examination,laboratory profile,and CXR performed at Screening.
- Patient must be able and willing to self-administer SC (sub-cutaneous) injections or have a qualified person available to administer SC injections.
- Patients must be able and willing to provide written informed consent and comply with the requirements of this study protocol.
Who cannot join
- Patient has a history of an allergic reaction or significant sensitivity to constituents of study drug (etanercept), including latex (a component of the pre-filled syringe).
- Patient has chronic or recurrent infection or history of listeriosis, histoplasmosis or any other invasive fungal or mycobacterial infections, treated or untreated Tuberculosis (TB), persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives drug within 30 days prior to the Day 0 visit or oral anti-infectives within 14 days prior to the Day 0 visit.
- Patient used any non-biological investigational agents within 30 days or 5 half-lives prior to Day 0 visit (whichever is longer).
- Patient who has used any biological therapy for the treatment of RA less than 3 months (90 days) or 5 half-lives prior to Day 0 visit (whichever is longer) or patient has received Anakinra/Kineret within the last 2 weeks prior to the Day 0 visit or is likely to receive Anakinra/Kineret during the course of the study.
- Patient has used a non-biological systemic therapy for the treatment of RA less than 30 days before Day 0, other than methotrexate.
- Patient is taking or requires oral or injectable corticosteroids at a dose equivalent to more than 5 mg of prednisone daily within 30 days of Day 0 and during the study. Inhaled corticosteroids for stable medical conditions are allowed. Patients taking oral or injectable corticosteroids must be on a stable dose for at least 3 months before Day 0.
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- Patient for whom the treating physician is planning to change the dose of methotrexate or oral corticosteroids during the study.
- Patient has used a systemic immunosuppressor (eg. Azathioprine, 6-mercaptopurine) less than 30 days before Day 0.
- Patient who has another musculoskeletal disease that could interfere with or prevent with joint examination
- Patient who had a myocardial infarction or hospitalization for a cardiac condition within the past 12 weeks.
- Patient has a pacemaker or a defibrillator.
- Patient who has a history of acute coronary syndrome, percutaneous coronary intervention, coronary artery dilatation bypass graft, coronary revascularization, carotid endarterectomy, stent installation or carotid revascularization within 12 weeks of baseline.
- Patient for whom a change in medical treatment for angina, serum lipids, hypertension or any other medication that can have a significant effect on inflammation is planned for the duration of the study.
- Patient with active or chronic Hepatitis B and /or Hepatitis C.
- Patient has a known sero-positivity for HIV virus or with or at risk of sepsis syndrome or history of any other immunosuppressive disease.
- Patient currently uses or plans to use anti-retroviral therapy at any time during the study.
- Patient has a poorly controlled medical condition, such as uncontrolled diabetes, documented history of recurrent infections, unstable ischemic heart disease, class III or IV (New York Heart Association Functional Classification; NYHA) congestive heart failure, an ejection fraction of less than 30%, recent stroke (within the past 3 months), chronic leg ulcer or any other condition which, in the opinion of the investigator, would put the patient at risk if participating in the study.
- Patient has lupus erythematosus or history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease (e.g. optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia)
- Patient has history of cancer or lymphoproliferative disease other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
- Female patient who is pregnant or male patient with a pregnant female partner or breast-feeding or considering becoming pregnant during the study or for 4 weeks after the last dose of study medication.
- Male patient with a female pregnant partner or breast-feeding or considering becoming pregnant during the study or for 4 weeks after the last dose of study medication who is not willing to use effective methods of birth control (a condom or sexual abstinence) during treatment, for the duration of the study and for 4 weeks after the end of treatment.
- Patient has a history of clinically significant drug or alcohol abuse in the last year.
- Patient has received a live attenuated vaccine 28 days or less before Day 0 or plan to receive a live attenuated vaccine during the study and up to 4 months after the last study drug administration.
- Patient with any clinically significant laboratory or exam results judged by the investigator that may put the patient at risk if participating in the study.
- Patient who plans to travel in an area where tuberculosis is endemic during the study and up to 4 months after the last study drug administration.
- Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Open-label Study of the Effect of Etanercept on Vascular Inflammation in Patients With Active Rheumatoid Arthritis
The primary goal of this preliminary project is to study the effect of etanercept, a medicine approved by Health Canada for the treatment of rheumatoid arthritis, on the inflammation of certain blood vessels. In particular, the inflammation of the aorta and the carotid arteries will be studied.
This study's goal is to determine if etanercept (that blocks TNF (tissue necrosis factor) alpha) could have an effect on blood vessel inflammation. As well, the information from this study will be used to determine the number of patients to recruit in a future study.
Read more
This study will evaluate the effect of etanercept on 10 patients with rheumatoid arthritis at one rheumatology clinic in Montreal. The 10 patients will be recruited at the Montreal Rheumatology Institute (Institut de Rhumatologie de Montréal) and the images of the blood vessels taken at a medical imaging center will be analyzed by the Montreal Heart Institute.
To evaluate vascular inflammation subjects will undergo a PET scan (Positron Emission Tomography).
Read the detailed description
This study is a 16 week, single center, open label trial, to study the effect of etanercept on vascular inflammation of the ascending aorta and carotid arteries in patients with rheumatoid arthritis (RA).
Patients with active RA already receiving methotrexate for at least 3 months will receive etanercept for 16 weeks. Etanercept will be administered sub-cutaneously using the dose approved in the Canadian product monograph for RA (50 mg every week). Patients will continue methotrexate at a stable dose during the study unless a dose reduction or cessation is required as judged necessary by the study investigator. Positron Emission Tomography (PET) Scan will be performed at baseline and after16 weeks of study treatment with etanercept. At the end of the study, all PET Scan images will be analyzed in a blinded manner by the Montreal Heart Institute core laboratory.
Safety will be assessed using adverse events collection and laboratory hematology and chemistry analysis (screening and Week 4) and pregnancy test.
- Conditions
- Rheumatoid Arthritis, Vascular Inflammation
- Being tested
- etanercept
- Keywords
- Anti-Tumor necrosis factor alpha, 18-FluoroDeoxyGlucose Positron Emission Tomography, High-sensitivity C- Reactive protein
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
etanerceptDrug
Also called Enbrel
Etanercept is a tumor necrosis factor antagonist
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate and Etanercept | Experimental | Patients already taking Methotrexate prior to the study will continue taking 15 mg weekly and start Etanercept 50 mg every week for 16 weeks Receives: Drug: etanercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target to background ratio (TBR) from the ascending aorta
Change from baseline in target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta.
Measured: 16 weeks
Secondary outcomes (7)
TBR from the mean of both carotid arteries
Change from baseline in the TBR from the mean of both carotid arteries
Measured: 16 Weeks
High Sensitivity C-reactive protein (hsCRP)
Change from baseline in hsCRP
Measured: 16 weeks
Count of swollen and tender joints
Change from baseline in swollen and tender joint count
Measured: 16 weeks
Correlation of TBR from the ascending aorta with hsCRP
Correlation between change from baseline in TBR from the ascending aorta and change from baseline in hsCRP
Measured: 16 weeks
Correlation of TBR from the mean of both carotid arteries with hsCRP
Correlation between change from baseline in TBR from the mean of both carotid arteries and change from baseline in hsCRP
Measured: 16 weeks
Correlation of TBR from the ascending aorta with swollen and tender joint count
Correlation between change from baseline in TBR from the ascending aorta at and change from baseline in swollen and tender joint count
Measured: 16 weeks
Correlation of TBR from the carotid arteries with swollen and tender joint count
Correlation between change from baseline in TBR from the carotid arteries and change from baseline in swollen and tender joint count
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: Recruitment difficulties
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boulos Haraoui, MD, Principal investigator, Institut de Rhumatologie de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02109289
- Sponsor's protocol ID
- Inno-6032
- Status last verified
- Feb 2017
- First submitted
- 3 Apr 2014
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Open-label Study of the Effect of Etanercept on Vascular Inflammation in Patients With Active Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02109289
- Acronym / sponsor ID
- Inno-6032
- Conditions
- Rheumatoid Arthritis, Vascular Inflammation
- Keywords
- Anti-Tumor necrosis factor alpha, 18-FluoroDeoxyGlucose Positron Emission Tomography, High-sensitivity C- Reactive protein
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment difficulties
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- Apr 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 9 Apr 2014 (estimated)
- 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.
The primary goal of this preliminary project is to study the effect of etanercept, a medicine approved by Health Canada for the treatment of rheumatoid arthritis, on the inflammation of certain blood vessels. In particular, the inflammation of the aorta and the carotid arteries will be studied.
This study's goal is to determine if etanercept (that blocks TNF (tissue necrosis factor) alpha) could have an effect on blood vessel inflammation. As well, the information from this study will be used to determine the number of patients to recruit in a future study.
This study will evaluate the effect of etanercept on 10 patients with rheumatoid arthritis at one rheumatology clinic in Montreal. The 10 patients will be recruited at the Montreal Rheumatology Institute (Institut de Rhumatologie de Montréal) and the images of the blood vessels taken at a medical imaging center will be analyzed by the Montreal Heart Institute.
To evaluate vascular inflammation subjects will undergo a PET scan (Positron Emission Tomography).
Detailed description
This study is a 16 week, single center, open label trial, to study the effect of etanercept on vascular inflammation of the ascending aorta and carotid arteries in patients with rheumatoid arthritis (RA).
Patients with active RA already receiving methotrexate for at least 3 months will receive etanercept for 16 weeks. Etanercept will be administered sub-cutaneously using the dose approved in the Canadian product monograph for RA (50 mg every week). Patients will continue methotrexate at a stable dose during the study unless a dose reduction or cessation is required as judged necessary by the study investigator. Positron Emission Tomography (PET) Scan will be performed at baseline and after16 weeks of study treatment with etanercept. At the end of the study, all PET Scan images will be analyzed in a blinded manner by the Montreal Heart Institute core laboratory.
Safety will be assessed using adverse events collection and laboratory hematology and chemistry analysis (screening and Week 4) and pregnancy test.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methotrexate and Etanercept | Experimental | Drug: etanerceptPatients already taking Methotrexate prior to the study will continue taking 15 mg weekly and start Etanercept 50 mg every week for 16 weeks |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Patient is 18 to 80 years of age, inclusive.
- Patient's weight at screening is a maximum of 180 kg.
- Patient has a clinical diagnosis of active RA for at least 3 months defined as:
- Patient with active synovitis despite treatment for at least 3 months with a dose of methotrexate of at least 15 mg per week.
- Patient is eligible to receive etanercept according to Canadian Product Monograph.
Key exclusion criteria (26 listed)
- Patient has a history of an allergic reaction or significant sensitivity to constituents of study drug (etanercept), including latex (a component of the pre-filled syringe).
- Patient has chronic or recurrent infection or history of listeriosis, histoplasmosis or any other invasive fungal or mycobacterial infections, treated or untreated Tuberculosis (TB), persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous anti-infectives drug within 30 days prior to the Day 0 visit or oral anti-infectives within 14 days prior to the Day 0 visit.
- Patient used any non-biological investigational agents within 30 days or 5 half-lives prior to Day 0 visit (whichever is longer).
- Patient who has used any biological therapy for the treatment of RA less than 3 months (90 days) or 5 half-lives prior to Day 0 visit (whichever is longer) or patient has received Anakinra/Kineret within the last 2 weeks prior to the Day 0 visit or is likely to receive Anakinra/Kineret during the course of the study.
- Patient has used a non-biological systemic therapy for the treatment of RA less than 30 days before Day 0, other than methotrexate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| etanerceptAlso: EnbrelEtanercept is a tumor necrosis factor antagonist | Drug | Methotrexate and Etanercept |
Primary outcome
Target to background ratio (TBR) from the ascending aorta
Time frame: 16 weeks
Change from baseline in target (atherosclerotic plaque) to background (blood) ratio (TBR) from the ascending aorta.
7 secondary outcomes
TBR from the mean of both carotid arteries
Time frame: 16 Weeks
High Sensitivity C-reactive protein (hsCRP)
Time frame: 16 weeks
Count of swollen and tender joints
Time frame: 16 weeks
Correlation of TBR from the ascending aorta with hsCRP
Time frame: 16 weeks
Correlation of TBR from the mean of both carotid arteries with hsCRP
Time frame: 16 weeks
Correlation of TBR from the ascending aorta with swollen and tender joint count
Time frame: 16 weeks
Correlation of TBR from the carotid arteries with swollen and tender joint count
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Boulos Haraoui, MD principal investigator
Institut de Rhumatologie de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing etanercept in people with Rheumatoid Arthritis and Vascular Inflammation, run by Innovaderm Research Inc. at 1 site in Canada.
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 22 inclusion and 26 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: stopped early, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment difficulties). Results are not available in the source record.
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?
Target to background ratio (TBR) from the ascending aorta (time frame: 16 weeks). 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 7 Feb 2017.