Trial Outcomes & Findings for Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients (NCT NCT01351480)

Last Updated: 2017-03-13

Results Overview

bone edema/osteitis using low-field MRI analysis of 25 anatomical locations in the wrist and hand and scoring the volume of the original articular bone in 0.5 increments from 0-3, with each increment in the scale representing 33% of the volume of the peripheral 1 cm of original (eroded + residual) articular bone.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

34 participants

Primary outcome timeframe

MRIs at Baseline and Week 48

Results posted on

2017-03-13

Participant Flow

Participant milestones

Participant milestones
Measure	Abatacept open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose
Overall Study STARTED	34
Overall Study COMPLETED	26
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Benefits of Injectable Abatacept Using Magnetic Resonance Imaging (MRI) in Rheumatoid Arthritis (RA) Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abatacept n=34 Participants open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Region of Enrollment United States	34 participants n=5 Participants

PRIMARY outcome

Timeframe: MRIs at Baseline and Week 48

Population: osteitis on the MRIs from 27 patients at baseline and week 48

Outcome measures

Outcome measures
Measure	Abatacept n=27 Participants open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose
Number of Participants With an Improvement in Bone Edema/Osteitis on Low-field MRI in Rheumatoid Arthritis Patients on Weekly SC Abatacept in Combination With Methotrexate Over a 12-month Period.	27 participants

SECONDARY outcome

Timeframe: The DAS 28 score will be performed at baseline and 48

Population: There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients

Patient with a positive change in DAS score were considered responders . The DAS score is calculated using the number of tender and swollen joints based upon a 28 joint count, the ESR in mm/hr., and the physician global score

Outcome measures

Outcome measures
Measure	Abatacept n=27 Participants open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose
Patients With an Improvement in DAS Score Were Considered Responders at Week 48	25 participants

SECONDARY outcome

Timeframe: Patient DAS 28 scores will be measured at baseline and weeks 12, 24, 48 and disease activity will be recorded at Week 48

Population: the number of participants who reached remission, low disease activity, moderate disease activity and high disease activity will be determined as based upon the DAS scale

DAS 28\> 5.1=high disease activity DAS28 \<3.2=low disease activity DAS28 \<2.6=remission Criteria used in formula are number of tender joints based upon 28 joints, number of swollen joints based on 28 joints, ESR in mm/hr and patient global health core based on 0-10 mm

Outcome measures

Outcome measures
Measure	Abatacept n=27 Participants open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 clinical remission at week 12	2 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 low disease activity at week 12	2 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 mod disease activity at week 12	12 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 high disease activity at week 12	11 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 clinical remission at week 24	1 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 low disease activity at week 24	2 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 moderate disease activity at week 24	14 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 high disease activity at week 24	8 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 clinical remission at week 48	4 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 low disease activity at week 48	6 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 moderate disease activity at week 48	8 participants
To Measure the Change From Baseline in Patient DAS 28 Scores at Baseline and Weeks 12, 24 high disease activity at week 48	7 participants

SECONDARY outcome

Timeframe: week 24 and Week 48

Population: There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients

Outcome measures

Outcome measures
Measure	Abatacept n=27 Participants open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose
the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48 clinical response at 6 months	20 participants
the Clinical Outcomes Measurements (American College of Rheumatology Activity Scoring, Health Assessment The Number of Patients With a Clinical Response at Week 24 and 48 clinical response at 12 months	25 participants

SECONDARY outcome

Timeframe: all adverse events will be captured from Day 1 up to 52 weeks

Population: There were 34 enrolled patients with 7 patients who early termed so analysis was performed on 27 patients

site will report the number of patients with adverse envents from Day 1 up to 52 weeks

Outcome measures

Outcome measures
Measure	Abatacept n=27 Participants open label use of abatacept for 12 months abatacept: Abatacept administered SC weekly at 125 mg dose
Number of Patients With Adverse Events	0 participants

Adverse Events

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

Norman B Gaylis, MD

AARDS Research, Inc.

Phone: 305-652-6676

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place