Trial Outcomes & Findings for Abatacept for SLE Arthritis (IM101-330) (NCT NCT02429934)

NCT ID: NCT02429934

Last Updated: 2021-05-13

Results Overview

Assessed by physical exam. Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 28 participants
• Primary outcome timeframe: Baseline, 8 Weeks, 16 Weeks
• Results posted on: 2021-05-13

Participant Flow

Participant milestones

Measure	Abatacept abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo Placebo subcutaneous injection weekly for 16 weeks
Overall Study STARTED	15	13
Overall Study COMPLETED	11	10
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Abatacept abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo Placebo subcutaneous injection weekly for 16 weeks
Overall Study Withdrawal by Subject	0	2
Overall Study Adverse Event	2	0
Overall Study Lost to Follow-up	1	1
Overall Study Physician Decision	1	0

Baseline Characteristics

Abatacept for SLE Arthritis (IM101-330)

Baseline characteristics by cohort

Measure	Abatacept n=15 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=13 Participants Placebo subcutaneous injection weekly for 16 weeks	Total n=28 Participants Total of all reporting groups
Age, Continuous	43.6 years STANDARD_DEVIATION 9.0 • n=5 Participants	40.8 years STANDARD_DEVIATION 15.3 • n=7 Participants	42.2 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants	13 participants n=7 Participants	28 participants n=5 Participants
education high school	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
education 2 year college	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
education 4 year college	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
education trade school	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
education master's degree	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
education professional	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
education other	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
insurance PPO	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
insurance HMO	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
insurance Medicare	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
insurance Medicaid	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
insurance unknown	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
smoking history never smoked	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
smoking history past smoker	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
smoking history current smoker	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 Weeks, 16 Weeks

Population: subjects that completed the 8 and 16 week study visits

Assessed by physical exam. Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit.

Outcome measures

Measure	Abatacept n=13 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=11 Participants Placebo subcutaneous injection weekly for 16 weeks
Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count 8 Weeks	11 Participants	11 Participants
Number of Participants With at Least a 20% Improvement From Baseline in Tender and Swollen 28 Joint Count 16 Weeks	10 Participants	10 Participants

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: completers at 16 weeks

Systemic Lupus Erythematosus Disease Activity Index (Modified in the year 2000) - The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease of 3 points in SLEDAI 2K is considered to be a clinically significant improvement.

Outcome measures

Measure	Abatacept n=11 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=10 Participants Placebo subcutaneous injection weekly for 16 weeks
Change in SLEDAI 2K	-1.4545 score on a scale Standard Deviation 3.2669	-3.4000 score on a scale Standard Deviation 2.8363

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: SLE subjects completing 16 weeks of treatment or placebo and attending the 16-week physician assessment visit.

Physician's Global Assessment (PGA) is a physician rating of patient's disease activity, with a range 0-3. A change of 0.8 points on a 3 point scale or less is considered as stable. Lower score means better outcome

Outcome measures

Measure	Abatacept n=10 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=10 Participants Placebo subcutaneous injection weekly for 16 weeks
Change in the PGA Score	-1.3650 points on scale Standard Deviation 3.7029	-0.3350 points on scale Standard Deviation 2.2289

SECONDARY outcome

Timeframe: 16 weeks

Population: sle subjects that completed 16 week assessment visit

CDAI is a simplified index for assessing disease activity comprising swollen joint counts (SJC), tender/painful joint counts (TJC), participant's global assessment of disease activity (PtGA) and physician's global assessment of disease activity (PGA). CDAI is the numerical sum of 4 outcome parameters: SJC and TJC (based on 28-joint assessment), PtGA and PGA (assessed on 0-10 cm visual analog scale; higher scores indicated greater affection due to disease activity). CDAI total score = 0-76. CDAI less than equal to (<=) 2.8 indicates disease remission, greater than (>) 2.8 to 10 = low disease activity, greater than (>) 10 to 22 = moderate disease activity, and >22 = high disease activity.

Outcome measures

Measure	Abatacept n=10 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=10 Participants Placebo subcutaneous injection weekly for 16 weeks
Clinical Disease Activity Index (CDAI) Index Score	14.7850 score on a scale Standard Deviation 12.0459	14.5700 score on a scale Standard Deviation 7.9701

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Population: completers of 16 weeks of treatment/placebo at one study center (UCLA)

Using ultrasound analysis, (Gray scale ultrasound) represents synovitis/tenosynovitis and identifies erosions. PDUS (power Doppler ultrasound) measures intensity of soft tissue inflammation by blood flow. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents PDUS. The Power Doppler Synovitis Score (PDUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation. A higher value of the total score for PDUS represents more severe disease level. 30 joints were evaluated using a 0 to 3 point scale for each joint and the sum of these represents GSUS. The grey scale synovial hypertrophy score (GSUS) ranges from 0 to 90. Scores of 0 indicate the least amount of inflammation of the joint. A higher value of the total score for GSUS represents more severe disease level.

Outcome measures

Measure	Abatacept n=4 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=4 Participants Placebo subcutaneous injection weekly for 16 weeks
Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS) baseline GSUS	17.50 score on scale Standard Deviation 7.05	16.00 score on scale Standard Deviation 4.83
Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS) 16 week GSUS	12.75 score on scale Standard Deviation 2.22	17.75 score on scale Standard Deviation 5.19
Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS) baseline PDUS	5.25 score on scale Standard Deviation 5.12	1.50 score on scale Standard Deviation 1.00
Synovitis, Tenosynovitis and Erosions Scores (GSUS and PDUS) 16 week PDUS	2.00 score on scale Standard Deviation 1.83	2.25 score on scale Standard Deviation 1.89

SECONDARY outcome

Timeframe: 16 weeks

Population: All subjects dosed with either abatacept or placebo at least once.

Total number of AEs and total number of SAEs as well as those AEs/SAEs which may be related to the study drug

Outcome measures

Measure	Abatacept n=15 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=13 Participants Placebo subcutaneous injection weekly for 16 weeks
Number of AEs and SAEs AEs grade II or less	20 adverse events	27 adverse events
Number of AEs and SAEs AEs not related	14 adverse events	14 adverse events
Number of AEs and SAEs AEs possibly related	5 adverse events	10 adverse events
Number of AEs and SAEs AEs probably related	1 adverse events	3 adverse events
Number of AEs and SAEs AEs grade III or higher	1 adverse events	0 adverse events
Number of AEs and SAEs SAEs	1 adverse events	0 adverse events

SECONDARY outcome

Timeframe: baseline, 4, 8, 12 and 16 weeks

Population: Each timepoint reports the number of participants who attended each visit for physician assessment

Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit

Outcome measures

Measure	Abatacept n=15 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=13 Participants Placebo subcutaneous injection weekly for 16 weeks
Number of Tender and Swollen Joints baseline	6.73 joints Standard Deviation 4.53	5.00 joints Standard Deviation 1.41
Number of Tender and Swollen Joints week 4	2.80 joints Standard Deviation 2.65	1.54 joints Standard Deviation 1.10
Number of Tender and Swollen Joints week 8	1.77 joints Standard Deviation 2.13	0.45 joints Standard Deviation 0.69
Number of Tender and Swollen Joints week 12	1.58 joints Standard Deviation 2.19	1.00 joints Standard Deviation 1.34
Number of Tender and Swollen Joints week 16	1.82 joints Standard Deviation 2.27	0.50 joints Standard Deviation 0.97

SECONDARY outcome

Timeframe: Baseline, 16 weeks

Total number of joints that are both swollen and tender were assessed in each participant by a physician at each study visit

Outcome measures

Measure	Abatacept n=11 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=10 Participants Placebo subcutaneous injection weekly for 16 weeks
Change in the Total Sum of Tender and Swollen Joints	-5.1818 Joints Standard Deviation 4.2619	-4.2000 Joints Standard Deviation 1.3116

SECONDARY outcome

Timeframe: 16 weeks

Population: This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day. Among all the subjects entered, 6 in each group were taking 10 mg of prednisone daily or higher at baseline

This analysis is for the subset of patients who start the study taking 10 to 20mg of prednisone per day.

Outcome measures

Measure	Abatacept n=6 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=6 Participants Placebo subcutaneous injection weekly for 16 weeks
Number of Patients Who Tapered Prednisone to <10mg/Day	2 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, 8 and 16 weeks

Population: Results are reported for the number of participants who completed the study visit/assessment at each time point

prednisone dose (mg/day) is recorded at baseline, 8 and 16 weeks for each subject being assessed at that study visit. Then a mean for all the subjects in each group at each time point was calculated.

Outcome measures

Measure	Abatacept n=15 Participants abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=13 Participants Placebo subcutaneous injection weekly for 16 weeks
Mean Prednisone Dose (mg/Day) baseline	4.73 mg per day Standard Deviation 7.73	4.77 mg per day Standard Deviation 6.64
Mean Prednisone Dose (mg/Day) 8 weeks	5.46 mg per day Standard Deviation 7.98	5.64 mg per day Standard Deviation 6.89
Mean Prednisone Dose (mg/Day) 16 weeks	8.45 mg per day Standard Deviation 10.04	5.70 mg per day Standard Deviation 7.99

Adverse Events

Abatacept

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Abatacept n=15 participants at risk abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=13 participants at risk Placebo subcutaneous injection weekly for 16 weeks
Renal and urinary disorders flare of lupus nephritis	6.7% 1/15 • Number of events 1 • Adverse events were collected for 20 weeks after initial dose (visit 1) We used clinicaltrials.gov definitions	0.00% 0/13 • Adverse events were collected for 20 weeks after initial dose (visit 1) We used clinicaltrials.gov definitions

Other adverse events

Measure	Abatacept n=15 participants at risk abatacept: 125mg injected subcutaneously weekly for 16 weeks	Placebo n=13 participants at risk Placebo subcutaneous injection weekly for 16 weeks
Skin and subcutaneous tissue disorders skin reaction at injection site	40.0% 6/15 • Number of events 9 • Adverse events were collected for 20 weeks after initial dose (visit 1) We used clinicaltrials.gov definitions	23.1% 3/13 • Number of events 4 • Adverse events were collected for 20 weeks after initial dose (visit 1) We used clinicaltrials.gov definitions

Additional Information

Dr. Bevra Hahn

University of California at Los Angeles

Phone: 8184869745

Email: bhahn@mednet.ucla.edu

Results disclosure agreements

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

Restriction type: LTE60