Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis

NCT02874092 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 15-01003
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Rheumatoid Arthritis

Keywords

Methotrexate (MTX); Ticagrelor

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Visual Analog Scale Disease Activity

  30 Days

• Change in Brachial Artery Diameter

  Baseline, 30 Days

Study Arms (2)

Rheumatoid Arthritis

ACTIVE COMPARATOR

-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks

Drug: Ticagrelor; Drug: MTX therapy

Osteoarthritis

ACTIVE COMPARATOR

-Diagnosis of osteoarthritis made by physician.

Drug: MTX therapy

Interventions

Ticagrelor DRUG

Rheumatoid Arthritis

MTX therapy DRUG

Osteoarthritis; Rheumatoid Arthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Dr. Jeffrey Berger
• Organization: NYU Langone

Jeffrey.Berger@nyulangone.org

212-263-0855

Study Officials

• Jeffrey Berger, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: August 22, 2016
• Study Start: November 15, 2016
• Primary Completion: April 19, 2019
• Study Completion: June 19, 2019
• Last Updated: October 25, 2021
• Results First Posted: October 25, 2021

Record last verified: 2021-09

Locations

US (1)