Rheumatoid ArthritisPhase 4TIMERANCT02874092
Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis
A Phase 4 study testing Ticagrelor and MTX therapy in people with Rheumatoid Arthritis, run by NYU Langone Health at 1 site in United States.
Trial summary
This is an open label study to assess the improvement in the Disease Activity Score for 28-joint counts (DAS28) with ticagrelor given at 90 mg twice daily in patients with RA who have active disease despite MTX therapy (as defined by the inclusion/exclusion criteria). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Ticagrelor and MTX therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2016to 19 Jun 2019
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- RA cohort
- Receiving MTX at stable doses of 10 to 25 mg weekly for at least 12 weeks
- Have a DAS28 of 3.2 or higher (The level of disease activity is considered to be low if the DAS28 is 3.2 or less) (Prevoo et al., 1995)
- OA cohort
- Diagnosis of osteoarthritis made by physician.
Who cannot join
- RA cohort
- History of sensitivity to study medications or any of their excipients
- Previous intolerance to MTX
- Current treatment with antiplatelet therapy
- Absolute indication for anti-platelet therapy
- Need for chronic oral anticoagulant therapy
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- Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
- Renal failure (eGFR <30 or requiring dialysis)
- A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
- Prior stroke
- Active pathological bleeding
- History of intracranial haemorrhage
- Life expectancy <12 months based on investigator's judgement
- Patients considered to be at risk of bradycardic events (e.g., known sick sinus syndrome or second or third degree atrioventricular [AV)] block) unless already treated with a permanent pacemaker
- Anemia (hematocrit < 27%)
- Platelet count < 100,000/ml
- Concomitant use of strong CYP 3A inhibitors or inducers
- History of thrombocytopenia or neutropenia
- Pregnant or nursing women, or females with a positive pregnancy test at screening
- Females of child bearing potential not using acceptable method of birth control prior to or during study
- Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)
- OA cohort:
- History of sensitivity to study medications or any of their excipients
- Current treatment with antiplatelet therapy
- Absolute indication for anti-platelet therapy
- Need for chronic oral anticoagulant therapy
- Severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy)
- Renal failure (eGFR <30 or requiring dialysis)
- A known bleeding diathesis, hemostatic or coagulation disorder, or prior major bleeding
- Prior stroke
- Active pathological bleeding
- History of intracranial haemorrhage
- Life expectancy <12 months based on investigator's judgement
- Anemia (hematocrit < 27%)
- Platelet count < 100,000/ml
- History of thrombocytopenia or neutropenia
- Pregnant or nursing women, or females with a positive pregnancy test at screening
- Females of child bearing potential not using acceptable method of birth control prior to or during study
- Concern for inability of the patient to comply with study procedures and/or follow up (eg, alcohol or drug abuse)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
This is an open label study to assess the improvement in the Disease Activity Score for 28-joint counts (DAS28) with ticagrelor given at 90 mg twice daily in patients with RA who have active disease despite MTX therapy (as defined by the inclusion/exclusion criteria). There will also be a cross sectional analysis of baseline platelet activity in subjects with rheumatoid arthritis and osteoarthritis. Subjects in the OA cohort will not receive any study medication, and will only have one study visit.
Patients will receive 90 mg ticagrelor orally bid. The patients will receive drug for 30-days. Methotrexate dose will remain stable throughout the study duration.
Read the detailed description
The two main goals of this study are to demonstrate the heightened cardiovascular risk in RA by comparing platelet activity, inflammation and endothelial function in baseline rheumatoid arthritis versus age- and sex-matched patients with osteoarthritis; and 2) to demonstrate the effect of ticagrelor in rheumatoid arthritis by the pre- and post- measures of clinical RA severity, platelet activity, inflammation and endothelial function in rheumatoid arthritis before and after ticagrelor therapy.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Ticagrelor, MTX therapy
- Keywords
- Methotrexate (MTX), Ticagrelor
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
MTX therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Rheumatoid Arthritis | Active comparator | -Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks Receives: Drug: Ticagrelor; Drug: MTX therapy |
| Osteoarthritis | Active comparator | -Diagnosis of osteoarthritis made by physician. Receives: Drug: MTX therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Activity Score for 28-joint Counts (DAS28)
The DAS28 is a composite score derived from 4 of these measures. This '28' version is a simplification of the original DAS score, which requires 44 joints to be counted. Other versions of the DAS28 allow the CRP to be used instead of the ESR, or the omission of either. To calculate the DAS28 your rheumatologist or specialist nurse will:-
count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), ask you (the patient) to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad).
These results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
The total scale range is from 2 to 10, with higher scores indicating more disease activity.
Measured: 30 Days
Secondary outcomes (2)
Visual Analog Scale Disease Activity
The VAS is a psychometric response scale that ranges from "no pain" (0) to "worst pain" (100); patients mark a line on a continuum to indicate how they are feeling. Provides global assessment of RA severity.
Measured: 30 Days
Change in Brachial Artery Diameter
Endothelial function is characterized by flow-mediated vasodilation of the brachial artery, which is measured by comparing the brachial artery diameter at rest the diameter after increased forearm blood flow (reactive hyperemia). Brachial artery reactivity testing (BART) is a noninvasive technique for evaluating endothelial function
Measured: Baseline, 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start15 Nov 2016
- Primary completion19 Apr 2019
- Study completion19 Jun 2019
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 Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Berger, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874092
- Sponsor's protocol ID
- 15-01003
- Acronym
- TIMERA
- Status last verified
- Sep 2021
- First submitted
- 17 Aug 2016
- Last updated
- 25 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02874092
- Acronym / sponsor ID
- TIMERA / 15-01003
- Conditions
- Rheumatoid Arthritis
- Keywords
- Methotrexate (MTX), Ticagrelor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Jun 2019 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Posted 25 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label study to assess the improvement in the Disease Activity Score for 28-joint counts (DAS28) with ticagrelor given at 90 mg twice daily in patients with RA who have active disease despite MTX therapy (as defined by the inclusion/exclusion criteria). There will also be a cross sectional analysis of baseline platelet activity in subjects with rheumatoid arthritis and osteoarthritis. Subjects in the OA cohort will not receive any study medication, and will only have one study visit.
Patients will receive 90 mg ticagrelor orally bid. The patients will receive drug for 30-days. Methotrexate dose will remain stable throughout the study duration.
Detailed description
The two main goals of this study are to demonstrate the heightened cardiovascular risk in RA by comparing platelet activity, inflammation and endothelial function in baseline rheumatoid arthritis versus age- and sex-matched patients with osteoarthritis; and 2) to demonstrate the effect of ticagrelor in rheumatoid arthritis by the pre- and post- measures of clinical RA severity, platelet activity, inflammation and endothelial function in rheumatoid arthritis before and after ticagrelor therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rheumatoid Arthritis | Active comparator | Drug: Ticagrelor, Drug: MTX therapy-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks |
| Osteoarthritis | Active comparator | Drug: MTX therapy-Diagnosis of osteoarthritis made by physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- RA cohort
- Receiving MTX at stable doses of 10 to 25 mg weekly for at least 12 weeks
- Have a DAS28 of 3.2 or higher (The level of disease activity is considered to be low if the DAS28 is 3.2 or less) (Prevoo et al., 1995)
- OA cohort
- Diagnosis of osteoarthritis made by physician.
Key exclusion criteria (39 listed)
- RA cohort
- History of sensitivity to study medications or any of their excipients
- Previous intolerance to MTX
- Current treatment with antiplatelet therapy
- Absolute indication for anti-platelet therapy
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 |
|---|---|---|
| Ticagrelor | Drug | Rheumatoid Arthritis |
| MTX therapy | Drug | Osteoarthritis, Rheumatoid Arthritis |
Primary outcome
Disease Activity Score for 28-joint Counts (DAS28)
Time frame: 30 Days
The DAS28 is a composite score derived from 4 of these measures. This '28' version is a simplification of the original DAS score, which requires 44 joints to be counted. Other versions of the DAS28 allow the CRP to be used instead of the ESR, or the omission of either. To calculate the DAS28 your rheumatologist or specialist nurse will:- count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), ask you (the patient) to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). These results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission. The total scale range is from 2 to 10, with higher scores indicating more disease activity.
2 secondary outcomes
Visual Analog Scale Disease Activity
Time frame: 30 Days
Change in Brachial Artery Diameter
Time frame: Baseline, 30 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jeffrey Berger, MD principal investigator
New York University Medical School
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 Ticagrelor and MTX therapy in people with Rheumatoid Arthritis, run by NYU Langone Health at 1 site in United States.
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 5 inclusion and 39 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 25 Oct 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2021). 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?
Disease Activity Score for 28-joint Counts (DAS28) (time frame: 30 Days). 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 25 Oct 2021.