Trial Outcomes & Findings for Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis (NCT NCT01299961)

Results Overview

The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

25 participants

Primary outcome timeframe

baseline, 12 months

Results posted on

2015-06-10

Participant Flow

A total of 34 RA patients were recruited from the UCLA rheumatology clinics between September 2011 to February 2013. However, we had a total of 9 screen fails.

Patients enrolled in the study were required to have RA, on stable RA medications, and naive to abatacept.

Participant milestones

Participant milestones
Measure	Subcutaneous Abatacept All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Overall Study STARTED	25
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Subcutaneous Abatacept All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Overall Study Adverse Event	3
Overall Study Lack of Efficacy	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Ultrasound Scores as Indication of Response to Subcutaneous Abatacept in Subjects With Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subcutaneous Abatacept n=25 Participants All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
Age, Continuous	52.6 years STANDARD_DEVIATION 13.4 • n=99 Participants
Sex: Female, Male Female	23 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Region of Enrollment United States	25 participants n=99 Participants

PRIMARY outcome

Timeframe: baseline, 12 months

Population: Total of 19 patients completed 12 mos

The 7-joint US inflammatory score includes the addition of synovial hypertrophy scores and power doppler scores.

Outcome measures

Outcome measures
Measure	Subcutaneous Abatacept n=19 Participants All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
12 Month Change in 7-Joint Ultrasound (US) Inflammatory Score	11.4 units on a scale Standard Deviation 13.1

SECONDARY outcome

Timeframe: baseline, 12 months

Population: As stated previously

There were seven different joints in the hands and wrists evaluated to score the PDUS.

Outcome measures

Outcome measures
Measure	Subcutaneous Abatacept n=19 Participants All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
12 Month Change in Power Doppler Ultrasound (PDUS) Scores	3.0 units on a scale Standard Deviation 3.7

SECONDARY outcome

Timeframe: baseline, 12 months

There were seven different joints in the hands and wrists evaluated to score the GSUS.

Outcome measures

Outcome measures
Measure	Subcutaneous Abatacept n=19 Participants All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
12 Month Change in Gray-scale Ultrasound (GSUS)	1.2 units on a scale Standard Deviation 3.7

Adverse Events

Subcutaneous Abatacept

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

Veena K. Ranganath, MD, MS Assistant Clinical Professor

UCLA

Phone: 310-825-3061

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place