Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis

NCT02769702 | Terminated Phase 4 Results DMC

• 1 other identifier: Acthar Uveitis Study
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Uveitis is an acute or chronic inflammatory condition of unknown etiology. Although uveitis often responds adequately to topical corticosteroids, there are many patients for which this treatment is either inadequate or not tolerated. A patient with inadequate response to treatment would manifest uveitis activity by slit lamp examination determination of anterior chamber cellularity. Lack of tolerance of therapy commonly manifests as ocular hypertension (greater than 21 mmHg measured by tonometry)complicating chronic topical corticosteroid administration, leading to glaucoma and permanent visual loss. Moreover, systemic corticosteroids may be required at a dose unsafe for chronic administration. In these situations, an immunosuppressive medication is often added as a "steroid-sparing" agent. If and when there is clinical response to the added immunosuppressive, the oral and/or topical corticosteroid dose can be reduced or eliminated to avoid toxicity. There are several reasons for believing that Acthar might be beneficial in the treatment of uveitis patients. In addition to increasing adrenal production or cortisol, Acthar has another important mechanisms of action mediated by its binding of melanocortin receptors. Melanocortin down-regulates activity of B and T lymphocytes, monocytes and macrophages. In animal studies, melanocortin peptides down-regulate T helper cells, up-regulate T Regulatory cells, and decrease B lymphocyte production of B Lymphocyte Stimulator. In macrophages, there is down-regulation of IL-1, IL-2, INF gamma, TNF alpha, nitric oxide and adhesion molecules. In other cells, in addition to IL-10 upregulation (monocytes), there is down-regulation of VACM and ECAM (endothelial cells), prostaglandins (fibroblasts) and MCP-1 and RANTES (renal tubules).CNS mediation of systemic inflammation may also be down-regulated by melanocortin receptor binding by Acthar.

Conditions

Uveitis

Keywords

Uveitis

Outcome Measures

Primary Outcomes (1)

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

  standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more cellularity.

  Baseline and 12 weeks

Secondary Outcomes (1)

• Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation

  Baseline and 12 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Acthar 80 IU SC twice w eek

Drug: Acthar

Interventions

Acthar DRUG

Acthar 80 IU SC twice a week

Also known as: Acthar Gel

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Active anterior uveitis requiring oral and/or topical corticosteroid therapy

You may not qualify if:

• Uncontrolled diabetes
• Uncontrolled glaucoma
• HIV infection or other infection for which corticosteroid therapy contraindicated
• Contraindication to ACTHAR
• Scleroderma
• Osteoporosis
• Ocular herpes simplex
• Systemic fungal infection
• Recent surgery
• Uncontrolled hypertension

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Mallinckrodt: collaborator

Study Sites (1)

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Uveitis

Interventions

Adrenocorticotropic Hormone

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Limitations and Caveats

This study was prematurely terminated, only 2 participants enrolled. Although results are reported they should be interpreted with caution due to small sample size.

Results Point of Contact

• Title: Richard Brasington MD
• Organization: Washington University School of Medicine

rbrasing@wustl.edu

314-454-7255

Study Officials

• Richard D Brasington, MD

  Washington U Rheumatology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2016
• First Posted: May 12, 2016
• Study Start: June 1, 2016
• Primary Completion: January 6, 2017
• Study Completion: January 6, 2017
• Last Updated: October 1, 2018
• Results First Posted: October 1, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)