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Trial Outcomes & Findings for Ticagrelor in Methotrexate-Resistant Rheumatoid Arthritis (NCT NCT02874092)

NCT ID: NCT02874092

Last Updated: 2021-10-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

9 participants

Primary outcome timeframe

30 Days

Results posted on

2021-10-25

Participant Flow

Participant milestones

Participant milestones
Measure
Rheumatoid Arthritis
-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks Ticagrelor MTX therapy
Osteoarthritis
-Diagnosis of osteoarthritis made by physician. MTX therapy
Overall Study
STARTED
7
2
Overall Study
COMPLETED
7
2
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Baseline age was only collected for the 7 RA participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Rheumatoid Arthritis
n=7 Participants
-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks Ticagrelor MTX therapy
Osteoarthritis
n=2 Participants
-Diagnosis of osteoarthritis made by physician. MTX therapy
Total
n=9 Participants
Total of all reporting groups
Age, Continuous
48 years
STANDARD_DEVIATION 16 • n=7 Participants • Baseline age was only collected for the 7 RA participants
—
48 years
STANDARD_DEVIATION 16 • n=7 Participants • Baseline age was only collected for the 7 RA participants
Sex: Female, Male
Female
6 Participants
n=7 Participants
2 Participants
n=2 Participants
8 Participants
n=9 Participants
Sex: Female, Male
Male
1 Participants
n=7 Participants
0 Participants
n=2 Participants
1 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
5 Participants
n=7 Participants
0 Participants
n=2 Participants
5 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
n=7 Participants
2 Participants
n=2 Participants
4 Participants
n=9 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=7 Participants
0 Participants
n=2 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=7 Participants
0 Participants
n=2 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Asian
0 Participants
n=7 Participants
0 Participants
n=2 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=7 Participants
0 Participants
n=2 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=7 Participants
2 Participants
n=2 Participants
3 Participants
n=9 Participants
Race (NIH/OMB)
White
6 Participants
n=7 Participants
0 Participants
n=2 Participants
6 Participants
n=9 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=7 Participants
0 Participants
n=2 Participants
0 Participants
n=9 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=7 Participants
0 Participants
n=2 Participants
0 Participants
n=9 Participants
Region of Enrollment
United States
7 participants
n=7 Participants
2 participants
n=2 Participants
9 participants
n=9 Participants

PRIMARY outcome

Timeframe: 30 Days

Population: The Osteoarthritis arm was removed; no data was collected for this arm due to low enrollment

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.

Outcome measures

Outcome measures
Measure
Rheumatoid Arthritis
n=7 Participants
-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks Ticagrelor MTX therapy
Disease Activity Score for 28-joint Counts (DAS28)
Baseline
5.7 score on a scale
Standard Deviation 0.4
Disease Activity Score for 28-joint Counts (DAS28)
30 days
4.3 score on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: 30 Days

Population: The Osteoarthritis arm was removed; no data was collected for this arm due to low enrollment

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.

Outcome measures

Outcome measures
Measure
Rheumatoid Arthritis
n=7 Participants
-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks Ticagrelor MTX therapy
Visual Analog Scale Disease Activity
Baseline
47 Units on VAS scale
Standard Deviation 22
Visual Analog Scale Disease Activity
30 days
23 Units on VAS scale
Standard Deviation 18

SECONDARY outcome

Timeframe: Baseline, 30 Days

Population: The Osteoarthritis arm was removed; no data was collected for this arm due to low enrollment

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

Outcome measures

Outcome measures
Measure
Rheumatoid Arthritis
n=7 Participants
-Receiving Methotrexate at stable doses of 10 to 25 mg weekly for at least 12 weeks Ticagrelor MTX therapy
Change in Brachial Artery Diameter
Baseline
2.5 mm
Standard Deviation 0.9
Change in Brachial Artery Diameter
30 days
2.5 mm
Standard Deviation 1.1

Adverse Events

Rheumatoid Arthritis

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Osteoarthritis

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey Berger

NYU Langone

Phone: 212-263-0855

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place