Rheumatoid Arthritis Clinical Trial
— TIMERAOfficial title:
Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis
Verified date | September 2021 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 9 |
Est. completion date | June 19, 2019 |
Est. primary completion date | April 19, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria 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. Exclusion Criteria: 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 - 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) |
Country | Name | City | State |
---|---|---|---|
United States | New York University School of Medicine | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
30 Days | |
Secondary | 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. | 30 Days | |
Secondary | 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 | Baseline, 30 Days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04226131 -
MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics
|
N/A | |
Completed |
NCT04171414 -
A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT02833350 -
Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)
|
Phase 2 | |
Completed |
NCT04255134 -
Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)
|
Phase 4 | |
Recruiting |
NCT05615246 -
Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
|
||
Completed |
NCT03248518 -
Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases
|
N/A | |
Completed |
NCT03514355 -
MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms
|
N/A | |
Recruiting |
NCT06005220 -
SBD121, a Synbiotic Medical Food for RA Management
|
N/A | |
Recruiting |
NCT05451615 -
Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis
|
Phase 3 | |
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT02037737 -
Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting
|
N/A | |
Recruiting |
NCT04079374 -
Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel
|
Phase 3 | |
Completed |
NCT02504268 -
Effects of Abatacept in Patients With Early Rheumatoid Arthritis
|
Phase 3 | |
Recruiting |
NCT05496855 -
Remote Care in People With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
Recruiting |
NCT06031415 -
Study of GS-0272 in Participants With Rheumatoid Arthritis
|
Phase 1 | |
Recruiting |
NCT06103773 -
A Study of Single and Multiple Oral Doses of TollB-001
|
Phase 1 | |
Completed |
NCT05999266 -
The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
|
||
Recruiting |
NCT05302934 -
Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
|
||
Recruiting |
NCT04169100 -
Novel Form of Acquired Long QT Syndrome
|
Phase 4 |