Trial Outcomes & Findings for Safety Study of Abatacept to Treat Refractory Sarcoidosis (NCT NCT00739960)

Results Overview

Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

24 weeks and 52 weeks

Results posted on

2020-03-23

Participant Flow

Participant milestones

Participant milestones
Measure	Abatacept Abatacept: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety Study of Abatacept to Treat Refractory Sarcoidosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label n=1 Participants Open label for Abatacept
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 weeks and 52 weeks

Population: Since this study was designed to be a safety study, we chose safety as the primary outcome. Any change of symptoms from baseline was considered possibly related to the study drug, although unlikely. The study was discontinued due to funding withdrawal caused by the principal investigator switching institutions.

Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.

Outcome measures

Outcome measures
Measure	Abatacept n=1 Participants Abatacept: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
Safety of Abatacept in Progressive Pulmonary Sarcoidosis.	1 participant adverse events

SECONDARY outcome

Timeframe: 24 weeks and 52 weeks

Population: Data was not collected for this Outcome Measure.

Outcome measures

Outcome data not reported

Adverse Events

Abatacept

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Abatacept n=1 participants at risk Abatacept: 10mg/kg IV (infusion directly into the vein of the arm) Day 1, week 2, week 4 and then every 4 week for 44 weeks.
Respiratory, thoracic and mediastinal disorders Worsening shortness of breath	100.0% 1/1 • Number of events 1 • 24 weeks. No serious adverse events were reported.

Additional Information

Nadera J Sweiss, MD

UIC

Phone: 312-996-5723

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place