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Study of H.P. ACTHAR Subcutaneous Gelatin (Gel)(Highly Purified Gel Injection) in Uveitis Patients

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ClinicalTrials.gov Identifier: NCT02764697
Recruitment Status : Completed
First Posted : May 6, 2016
Results First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Collaborator:
Mallinckrodt
Information provided by (Responsible Party):
Tampa Bay Uveitis Center, LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Uveitis
Anterior Uveitis
Intermediate Uveitis
Posterior Uveitis
Scleritis
Clinically Significant Macular Edema
Intervention Drug: H.P. ACTHAR SUBCUTANEOUS GEL INJECTION
Enrollment 6
Recruitment Details

The recruitment period was 06/31/2016 through 08/10/2016

Active follow-up period 06/31/2016 through 12/07/2016

The study was conducted at 1 site Tampa Bay Uveitis Center, LLC 5800 49th Street North, St Petersburg Fl 33709: Outpatient Medical Clinic

Pre-assignment Details The patient after consent was given, were required to have their medical records reviewed and have screening laboratory evaluations
Arm/Group Title H.P. Acthar Subcutaneous Gel Injection
Hide Arm/Group Description

For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly

Period Title: Overall Study
Started 5
Completed 2
Not Completed 3
Reason Not Completed
Lack of Efficacy             3
Arm/Group Title H.P. Acthar Subcutaneous Gel Injection
Hide Arm/Group Description

For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  80.0%
>=65 years
1
  20.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
4
  80.0%
White
1
  20.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography
Hide Description Subjects will have fundus photography at baseline and 12 weeks. Intermediate uveitis is graded by haze; it is done using the photographic scale: grades 0-4 (lower values are a better outcome), utilized by the SUN criteria, based on the Nussenblatt photographic vitreous haze scale
Time Frame 12 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title H.P. Acthar Subcutaneous Gel Injection
Hide Arm/Group Description:

For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
1 Step of VH Improvement
3
  60.0%
2 Step of VH
1
  20.0%
No VH Improvement
1
  20.0%
2.Primary Outcome
Title Number of Participants With Clinically Significant Improvement of Macular Edema
Hide Description Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
0
Arm/Group Title H.P. Acthar Subcutaneous Gel Injection
Hide Arm/Group Description:

For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly

Overall Number of Participants Analyzed 5
Measure Type: Count of Participants
Unit of Measure: Participants
Decrease in Central Foveal Thickness <300
0
   0.0%
Decrease in central Fovea > 300 Microns
5
 100.0%
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title H.P. Acthar Subcutaneous Gel Injection
Hide Arm/Group Description

For the current protocol we are proposing, 40 U/ml, given twice weekly x 8 weeks, followed by once weekly x 4 weeks: a total 20 doses, using the approved route, with the option to do 4 additional doses if resolution is incomplete.

H.P. ACTHAR SUBCUTANEOUS GEL INJECTION: Subcutaneous injection twice weekly

All-Cause Mortality
H.P. Acthar Subcutaneous Gel Injection
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Serious Adverse Events
H.P. Acthar Subcutaneous Gel Injection
Affected / at Risk (%)
Total   0/5 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
H.P. Acthar Subcutaneous Gel Injection
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Grace Levy Clarke
Organization: Tampa Bay Uveitis Center, LLC
Phone: 855 798 8393
EMail: grace@tampabayuveitis.com
Layout table for additonal information
Responsible Party: Tampa Bay Uveitis Center, LLC
ClinicalTrials.gov Identifier: NCT02764697    
Other Study ID Numbers: TBUC 10012015
First Submitted: April 25, 2016
First Posted: May 6, 2016
Results First Submitted: November 23, 2017
Results First Posted: July 2, 2018
Last Update Posted: July 2, 2018