All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019

JIA Associated Uveitis

Golimumab

Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab

Medical University of Graz

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.

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

H.P. Acthar Subcutaneous Gel Injection

Sex: Female, Male

Race (NIH/OMB)

Region of Enrollment

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

Number of Participants With Photographic Haze Reduced to Grade 0 or Down 2 Steps Documented With Fundus Photography

Clinically Significant Uveitic Macular Edema: Clinical Improvement of Macular Edema with OCT Documentation of central foveal thickness < 300 microns

Number of Participants With Clinically Significant Improvement of Macular Edema

Overall Study

Dr. Grace Levy Clarke

Uveitis

Anterior Uveitis

Intermediate Uveitis

Posterior Uveitis

Scleritis

Clinically Significant Macular Edema

H.P. ACTHAR SUBCUTANEOUS GEL INJECTION

Tampa Bay Uveitis Center

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

Prospective Open Label Study of H.P. Acthar Gel Injection in Patients With Active Non-Infectious Uveitis With Associated Glaucoma Thus High Frequency Regional Corticosteroid and Oral Corticosteroids Cause Intolerable Side-Effects

Tampa Bay Uveitis Center, LLC

Mallinckrodt

Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis.

Migraine Prophylaxis

Histamine Dihydrochloride

Subcutaneous placebo (Evan's solution = phenol 0.4%, isotonic sodium chloride).

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis

Phase II Study to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis

Mean change from baseline in monthly migraine days [time frame: baseline and average over Weeks 3-22].

Mean change from baseline in monthly migraine days by 4 week intervals [Weeks 3-6, 7-10, 11-14, 15-18, 19-22].

Mean Change from Baseline in Monthly Migraine Index (MMI) [ Time Frame: baseline and average over observation period (Weeks 3-22).
Monthly Migraine Index (MMI):
Migraine headaches are assigned a number based on the peak intensity of that migraine headache:
1 for a mild migraine headache
2 for a moderate migraine headache
3 for a severe migraine headache.
The MMI is calculated as follows:
MMI= Sum of [(Migraine Peak Intensity Level (1-3)) x (Migraine Duration (hours))] / (Distinct Number of Migraine Headaches for that 4 week period)
Sample Calculation:
The patient experiences 3 migraine headaches (M1, M2, and M3) in 4 weeks . M1: Intensity Level 3, Duration is 7 hrs M2: Intensity Level 2, Duration 3 hrs M3: Intensity Level 3, Duration 15 hrs MMI= (3x7 + 2x3 + 3x15) / 3 = 24

Mean change from baseline in monthly number of migraines [time frame: baseline and over Weeks 3-22].

Mean change from baseline in monthly number of migraines by 4 week intervals [Weeks 3-6, 7-10, 11-14, 15-18, 19-22].

photophobia/nekroos

Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Subcutaneous Histamine Dihydrochloride for Migraine Prophylaxis

Infliximab to Treat Non-Infectious Scleritis

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