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Logistical challenges; no safety concerns
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The main reason for this study is to see if Acthar Gel can reduce inflammation in the uvea.
Also, safety information when using it for this purpose will be collected.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acthar Gel | Other | Participants received Acthar 1 mL (80 units [U]) subcutaneously (SC) 2 times per week for 36 weeks followed by a taper to Acthar 1 mL (80 U) SC once a week for 2 weeks, then 0.5 mL (40 U) SC once a week for 2 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acthar Gel | Drug | Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Nussenblatt Grading Scale | The Nussenblatt grading scale uses photographic measurement of cloudy, declining vision (vitreous haze). The scale goes from 0 to 4, and lower scores are better. | Week 36 |
| Score on the Laser Flare Scale | Protein that escapes from blood vessels inside the eye make a sudden burst of scattered light (flare) when a laser shines on them. This is called a laser flare. It is used to measure the amount and size of proteins in the clear fluid in the front of the eyeball (aqueous humour). The larger the flare, the more inflammation is inside the eye (intraocular inflammation) in patients with uveitis. Laser flare is scored on a scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Lower scores are better. | Week 36 |
| Score on the Aqueous Cell Scale | The number of cells (like white blood cells) floating in the aqueous humour (aqueous cells) are measured on a scale from 0 (none) to 4 (more than 30 cells), and lower scores are better. | Week 36 |
| Measure | Description | Time Frame |
|---|---|---|
| Diurnal Intraocular Pressure (IOP) | Eye pressure is measured in millimeters of mercury (mmHg). Normal eye pressure ranges from 12-22 mmHg, and eye pressure greater than 22 mmHg is considered higher than normal. During a 24-hour period, IOP normally varies by 2 to 6 mmHg because of different amounts of secretion and drainage at different times of the day. The word diurnal means "around the day," and IOP means "pressure inside the eye", so diurnal IOP is the measure of pressure inside the eye during a 24-hour period. Diurnal IOP is measured in millimeters of mercury (mmHg) using Goldmann Applanation Tonometry (GAT). Lower scores are better. |
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Inclusion criteria:
Is male or nonpregnant, nonlactating female
Has been diagnosed with current severe NIPPU
Has active disease at the Baseline Visit as defined by the presence of at least 1 of the following parameters in at least one eye despite at least 2 weeks of maintenance therapy with oral prednisone (or oral corticosteroid equivalent):
Is willing to taper current doses of corticosteroid and immunomodulatory therapy to the minimum effective dose during the study.
If under treatment with any immunosuppressants, immunomodulators, or biologic agents for a comorbid condition, has been on a stable dose for 2 weeks before screening
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Team Lead | Mallinckrodt | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blue Ocean Clinical Research | Clearwater | Florida | 33761 | United States | ||
| Midwest Eye Institute |
Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03656692) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.
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Approximately 30 participants were planned, but only 5 enrolled before the study was terminated
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| ID | Title | Description |
|---|---|---|
| FG000 | Acthar Gel | Participants receive Acthar Gel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 18, 2019 |
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| Week 36 |
| Indianapolis |
| Indiana |
| 46290 |
| United States |
| Massachusetts Eye Research and Surgery Institution (MERSI) | Waltham | Massachusetts | 02451 | United States |
| Metropolitan Eye Research and Surgery Institute | Palisades Park | New Jersey | 07650 | United States |
| Bergstrom Eye Research, LLC | Fargo | North Dakota | 58103 | United States |
| Valley Retina Institute, PA | McAllen | Texas | 78503 | United States |
| Foresight Studies, LLC | San Antonio | Texas | 78240 | United States |
| Virginia Eye Consultants | Norfolk | Virginia | 23502 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Modified Intent to Treat population included all participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Acthar Gel | Participants receive Acthar Gel |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Score on the Nussenblatt Grading Scale | The Nussenblatt grading scale uses photographic measurement of cloudy, declining vision (vitreous haze). The scale goes from 0 to 4, and lower scores are better. | Data were not collected. | Posted | Week 36 |
|
| |||||||||||||||||||
| Primary | Score on the Laser Flare Scale | Protein that escapes from blood vessels inside the eye make a sudden burst of scattered light (flare) when a laser shines on them. This is called a laser flare. It is used to measure the amount and size of proteins in the clear fluid in the front of the eyeball (aqueous humour). The larger the flare, the more inflammation is inside the eye (intraocular inflammation) in patients with uveitis. Laser flare is scored on a scale from 0 (no visible flare when compared with the normal eye) to 3 (severe - very dense flare). Lower scores are better. | Data were not collected. | Posted | Week 36 |
|
| |||||||||||||||||||
| Primary | Score on the Aqueous Cell Scale | The number of cells (like white blood cells) floating in the aqueous humour (aqueous cells) are measured on a scale from 0 (none) to 4 (more than 30 cells), and lower scores are better. | Data were not collected. | Posted | Week 36 |
|
| |||||||||||||||||||
| Secondary | Diurnal Intraocular Pressure (IOP) | Eye pressure is measured in millimeters of mercury (mmHg). Normal eye pressure ranges from 12-22 mmHg, and eye pressure greater than 22 mmHg is considered higher than normal. During a 24-hour period, IOP normally varies by 2 to 6 mmHg because of different amounts of secretion and drainage at different times of the day. The word diurnal means "around the day," and IOP means "pressure inside the eye", so diurnal IOP is the measure of pressure inside the eye during a 24-hour period. Diurnal IOP is measured in millimeters of mercury (mmHg) using Goldmann Applanation Tonometry (GAT). Lower scores are better. | Data were not collected. | Posted | Week 36 |
|
|
Up to 44 weeks
Treatment Emergent non-serious adverse events and all serious adverse events are reported. Treatment emergent adverse events are those that started or got worse after the first dose of study drug. Clinically significant change in vital signs, laboratory values and/or physical examinations are recorded as adverse events.
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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 | Acthar Gel | Participants receive Acthar Gel | 0 | 5 | 0 | 5 | 5 | 5 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iris adhesions | Eye disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Intraocular pressure increased | Investigations | MedDRA (23.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (23.0) | Systematic Assessment |
| |
| Uveitis | Eye disorders | MedDRA (23.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Information Call Center | Mallinckrodt | 800-844-2830 | medinfo@mnk.com |
| Jun 18, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015866 | Uveitis, Posterior |
| D015867 | Uveitis, Intermediate |
| D015864 | Panuveitis |
| ID | Term |
|---|---|
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000324 | Adrenocorticotropic Hormone |
| ID | Term |
|---|---|
| D053486 | Melanocortins |
| D011333 | Pro-Opiomelanocortin |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|