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Funding has been pulled
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| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
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The purpose of this study is to determine how safe and effective Abatacept is in treating patients who have progressive pulmonary sarcoidosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Abatacept in Progressive Pulmonary Sarcoidosis. | Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept. | 24 weeks and 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 6-minute Walk Distance. | 24 weeks and 52 weeks |
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Primary Inclusion Criteria:
Primary Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadera J Sweiss, MD | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | Open label for Abatacept |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Safety of Abatacept in Progressive Pulmonary Sarcoidosis. | Adverse events that are considered by the investigator to be reasonably or probably related to Abatacept. | 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. | Posted | Number | participant adverse events | 24 weeks and 52 weeks |
|
24 weeks.
No serious adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening shortness of breath | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | The patient had advanced fibrotic pulmonary sarcoidosis. It was unclear whether the worsening shortness of breath was due to the disease or to the study drug. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nadera J Sweiss, MD | UIC | 312-996-5723 | nsweiss@uic.edu |
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| ID | Term |
|---|---|
| D012507 | Sarcoidosis |
| ID | Term |
|---|---|
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Change From Baseline in 6-minute Walk Distance. | Data was not collected for this Outcome Measure. | Posted | 24 weeks and 52 weeks |
|
|
| 0 |
| 1 |
| 1 |
| 1 |
|
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| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D001798 |
| Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |