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NCT02874092: TIMERA

Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis

Completed Phase 4 Results posted Last updated 25 October 2021
What this trial tests

Phase 4 trial testing Ticagrelor in Rheumatoid Arthritis in 9 participants. Completed in 19 June 2019.

Timeline
15 November 2016
Primary endpoint
19 April 2019
19 June 2019

Quick facts

Lead sponsorNYU Langone Health
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment9
Start date15 November 2016
Primary completion19 April 2019
Estimated completion19 June 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

NYU Langone Health — full company profile →

Who can join

18 and older, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Disease Activity Score for 28-joint Counts (DAS28) Primary · 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' (i

Baseline
GroupValue95% CI
Rheumatoid Arthritis5.7± 0.4
30 days
GroupValue95% CI
Rheumatoid Arthritis4.3± 0.8
Visual Analog Scale Disease Activity Secondary · 30 Days

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.

Baseline
GroupValue95% CI
Rheumatoid Arthritis47± 22
30 days
GroupValue95% CI
Rheumatoid Arthritis23± 18
Change in Brachial Artery Diameter Secondary · Baseline, 30 Days

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
GroupValue95% CI
Rheumatoid Arthritis2.5± 0.9
30 days
GroupValue95% CI
Rheumatoid Arthritis2.5± 1.1

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Platelet Glycoprotein Ib α-Chain as a Putative Therapeutic Target for Juvenile Idiopathic Arthritis: A Mendelian Randomization Study.
    Luo S, Clarke SLN, Ramanan AV, Thompson SD, et al · · 2021 · cited 10× · PMID 33079445 · DOI 10.1002/art.41561
  2. Ticagrelor added to methotrexate improves rheumatoid arthritis disease severity.
    Garshick MS, Rosenthal PB, Luttrell-Williams E, Cronstein BN, et al · · 2021 · cited 6× · PMID 34142122 · DOI 10.1093/rheumatology/keab481

Verify or expand the search:

Other trials of Ticagrelor

Trials testing the same drug.

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

Other NYU Langone Health trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02874092.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing