ACTH

Compare the proportion of surgically treated patients with complete biochemical remission in the overall cohort between two groups

Determining if Acthar treatment improves disease progression

serum cortisol-peak 30 min after ACTH-stimulation

Measurement of pain

Pain VAS

circulation at baseline and after acute ACTH stimulation

24-hour proteinuria excretion

BDNF Expression

17-hydroxyprogesterone Responses to hCG in PCOS Women and Normal Controls

level of proteinuria

ARMS (Assessing Relapses in Multiple Sclerosis) ADL Scores (Activities of Daily Living)

ACTH stimulation test

Pearson Correlation of the Total Cortisol Levels Between the ITT and CSTs

PET measure: [11C]-(+)-PHNO binding

Percentage of patients with reduction of >1.2 points in DAS-28 score

Degree of aqueous and vitreous inflammatory cells-change is being assessed

Percentage of Patients With Clinically Significant Improvement in Visual Acuity

Evidence for improvement in the EEG one month following initiation of the 2 week course of low-dose ACTH.

Reduction of proteinuria in idiopathic membranous glomerulonephritis (MGN) and other forms of glomerulopathy including focal segmental glomerulosclerosis (FSGS) and advanced diabetic nephropathy

Part 1: Number of Participants With Low Disease Activity (LDA) by Visit

Number of Participants With Adverse Events

Percentage of Participants With Complete or Partial Remission in Proteinuria at 24 Weeks

Percentage of responders to Acthar at the end of treatment.

Number of Participants Who Meet the Definition of a Responder Within 4 Weeks

Retinal Nerve Fiber Layer (RNFL) thickness

Score on the Expanded Disability Status Scale (EDSS) at Baseline and Day 42

ACR 20 response ACR 20 response

Comparison of EDSS Mean Recovery between 5-day vs 14-day SQ 80 IU ACTHar Gel therapy groups

Serum cortisol concentrations during intravenous injection of 1 mcg adrenocorticotropic hormone through short cannula and during direct intravenous injection, in healthy participants.

Steroid toxicity

The effect of corticotrophin release hormone (CRH) on duodenal mast cell count

Visual Analog scale for injection comfort

Change From Baseline in Cutaneous Dermatomyositis at 6 Months

Dry Eye Comfort Questionnaire, SANDE

24 Hour Proteinuria

Significant Reduction in Proteinuria to Remission Levels During the Treatment Period (Includes Complete and Partial Remission, as Defined in the Outcome Measure Description Below)

Change in Myelin Water Fraction (MWF) Within New Enhancing Lesions Over the Course of 12 Months

Percentage of patients achieving less than 300 mg protein per 24 hours after 6 months of Acthar Gel.

SLEDAI-2K score

Primary Clinical Endpoint

Number of Patients With a Complete Response (CR)

Change From Baseline in the Ritchey-Camp Articular Index

Neuroinflammation in cortical and/or subcortical structures

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

Change in T1 Lesion Relaxation Time

Score on the Nussenblatt Grading Scale

Karnofsky Performance Status (KPS) Score

Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination

Number of Participants That Show a Decrease in Blood CXCL9 Levels by 50%

50% Reduction in Proteinuria or Proteinuria < 150mg/Day

To determine if preemptive cooling provides protection against worsening of INO and its effect on reading, with body heating.

17-hydroxyprogesterone Response to ACTH

Rate of Recurrence of FSGS as Seen in Renal Transplant Biopsies Proteinuria

Fatigue at 28 Weeks

Degree of inflammation after short term treatment, as measured by a pathologist during histological assessment

Treatment Period: Scores on a Scale for Telephone-administered Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)

Mean percentage reduction of spam (Baseline mean weekly spasm rate - mean weekly spasm rate on 6th week of therapy/Baseline mean weekly spasm rate * 100) is compared in both arms

Change in Cortical Excitability

Improvement in EDSS (Expanded Disability Status Scale) and Kurtzke Functional Scale (to assess individual disabilities).

Reduction of 24 hour urine calcium

The change in SASI induration & erythema score.

Proportion of androgen receptor pathway inhibitor (ARPI) -naïve metastatic castration-resistant prostate cancer (mCRPC) participants with Prostate Specific Antigen (PSA) decline ≥ 90% (Cohort 1)

Change in the number of active oral aphthous ulcers from baseline to Week 12

Proportion of Patients Exhibiting a 20% Worsening in T25FW at 36 Months

Rate of blood patch use

Percent Change in Estimated Glomerular Filtration Rate (eGFR) at Visit 12

Change in grade of pain on an 11-point pain intensity numerical rating scale (NRS).

Incidence of ocular adverse events (AEs)

Average total number of headache days (both 40IU and 80IU groups)

Improvement in Disease Activity as Measured by ACR20 and ACR50.

Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).

change in proteinuria from baseline to value at 3 months .

Annualized Relapse Rate

Change in proteinuria

Renal Function

Change in calculated free testosterone concentrations

To determine effect of CRH stimulation on 18F-FDG uptake in high-resolution PET-imaging of ACTH-adenomas in CD.

Change in mean aqueous levels of albumin in post-operative PVR patients receiving subcutaneous injections of H.P. Acthar® versus controls

Difference between VEGF levels at baseline and the peak VEGF level after low dose cosyntropin administration in healthy children and adolescents