Sarcoidosis
Conditions
Brief summary
The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.
Interventions
DRUGAbatacept
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.
Sponsors
Bristol-Myers Squibb
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Primary Inclusion Criteria: * Diagnosis of sarcoidosis for at least 1 year with lung disease * Active disease despite current treatment * On a stable dose of sarcoidosis treatment with oral steroids, methotrexate, or hydroxychloroquine, for at least 90 days Primary
Exclusion criteria
* Previous treatment with Abatacept * Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) * Currently receiving or received within the last 30 days the following: cyclosporine, tacrolimus or leflunomide * Previous treatment of IVIg within the last 6 months * History of chronic infection that has been active within last 60 days, or herpes zoster within last 6 months, or any infection requiring hospitalization or intravenous medication within last 60 days or oral medication within the last 2 weeks * History of congestive heart failure * HIV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Abatacept in Progressive Pulmonary Sarcoidosis. | 24 weeks and 52 weeks | Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept. |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in 6-minute Walk Distance. | 24 weeks and 52 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Open label for Abatacept | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Open Label |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Region of Enrollment United States | 1 participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 1 |
| serious Total, serious adverse events | 0 / 1 |
Outcome results
Primary
Safety of Abatacept in Progressive Pulmonary Sarcoidosis.
Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Abatacept | Safety of Abatacept in Progressive Pulmonary Sarcoidosis. | 1 participant adverse events |
Secondary
Change From Baseline in 6-minute Walk Distance.
Time frame: 24 weeks and 52 weeks
Population: Data was not collected for this Outcome Measure.