Trial Outcomes & Findings for A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis (NCT NCT03882008)

NCT ID: NCT03882008

Last Updated: 2024-07-30

Results Overview

Baseline levels of T cell-associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

25 participants

Primary outcome timeframe

14 Weeks

Results posted on

2024-07-30

Participant Flow

Participant milestones

Participant milestones
Measure	Abatacept Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Overall Study STARTED	25
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Abatacept Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Overall Study Withdrawal by Subject	1
Overall Study Lost to Follow-up	1

Baseline Characteristics

A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abatacept n=25 Participants Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=99 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants
Sex: Female, Male Female	22 Participants n=99 Participants
Sex: Female, Male Male	3 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	3 Participants n=99 Participants
Race (NIH/OMB) White	18 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=99 Participants
Region of Enrollment United States	25 participants n=99 Participants

PRIMARY outcome

Timeframe: 14 Weeks

Outcome measures

Outcome measures
Measure	Abatacept n=23 Participants Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 14	9 participants

SECONDARY outcome

Timeframe: 24 Weeks

Baseline levels of T cell associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept

Outcome measures

Outcome measures
Measure	Abatacept n=23 Participants Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 24	14 participants

SECONDARY outcome

Timeframe: Week 24

Baseline levels of T cell associated biomarkers predict ACR50 response (improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept

Outcome measures

Outcome measures
Measure	Abatacept n=23 Participants Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Number of Participants With American College of Rheumatology (ACR) 50 Response at Week 24	10 participants

SECONDARY outcome

Timeframe: Week 24

Baseline levels of T cell associated biomarkers predict ACR70 response (improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept

Outcome measures

Outcome measures
Measure	Abatacept n=23 Participants Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Number of Participants With American College of Rheumatology (ACR) 70 Response at Week 24	3 participants

SECONDARY outcome

Timeframe: Week 24

Baseline levels of T cell associated biomarkers predict EULAR good or moderate response (disease activity index for RA generated from tender and swollen joint count, patient global assessment, ESR or C-reactive protein) with subcutaneous abatacept

Outcome measures

Outcome measures
Measure	Abatacept n=23 Participants Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Number of Participants With European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24	17 participants

Adverse Events

Abatacept

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Abatacept n=25 participants at risk Subjects will receive abatacept 125mg subcutaneous injection once a week for 24 doses (24 weeks)
Infections and infestations upper respiratory infection	12.0% 3/25 • From time of study drug administration to end of study (week 24 or safety follow-up visit, if needed), up to 39 weeks
Nervous system disorders headaches	12.0% 3/25 • From time of study drug administration to end of study (week 24 or safety follow-up visit, if needed), up to 39 weeks
Gastrointestinal disorders abdominal pain	8.0% 2/25 • From time of study drug administration to end of study (week 24 or safety follow-up visit, if needed), up to 39 weeks

Additional Information

Bobby Kwanghoon Han

University of Washington

Phone: 206-685-9950

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place