Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02874092
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

NYU Langone Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jeffrey Berger, MD
Principal Investigator Affiliation New York University Medical School
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York University School of Medicine, New York, New York

Status

Recruiting

Address

New York University School of Medicine

New York, New York, 10016

Site Contact

Jessica Poon

[email protected]

646 501 7194