Trial record 1 of 1 for:    NCT02769702
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Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02769702
Recruitment Status : Recruiting
First Posted : May 12, 2016
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Uveitis Drug: Acthar Phase 4

Detailed Description:
Patients eligible for the study will be identified by the investigators and given a copy of the consent form to read. Patients interested in enrolling will be screened and if eligible will be enrolled in the study. The screening visit and the baseline visit may occur on the same day. Patients enrolling will be instructed in self-administering Acthar 80 IU twice a week. Patients will keep an injection log which will be inspected at each visit (4, 8, and 12 weeks). Ophthalmology data will be collected at each visit and recorded on the case report form by the ophthalmology technician working with the sub-investigator at the time of each visit. Patients will come to the Center for Clinical Studies each visit for blood draw, blood pressure recording, and recording of adverse events.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis Who Are Not Well Controlled With, or Intolerant of, Topical or Systemic Corticosteroids
Study Start Date : June 2016
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Intervention
Acthar 80 IU SC twice w eek
Drug: Acthar
Acthar 80 IU SC twice a week
Other Name: Acthar Gel

Primary Outcome Measures :
  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 [ Time Frame: 12 weeks ]
    standard assessment of uveitis activity

Secondary Outcome Measures :
  1. Change in baseline in eye with uveitis of anterior chamber protein graded 0-4 on a Likert scale determined by slit lamp evaluation [ Time Frame: 12 weeks ]
    standard assessment of uveitis activity

  2. Change from baseline in ocular coherence tomography [ Time Frame: 12 weeks ]
    standard assessment of uveitis activity

  3. Best corrected visual acuity [ Time Frame: 12 weeks ]
    Visual acuity

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02769702

Contact: RIchard D Brasington, MD 3144547255
Contact: Teresa Arb, RN 3147471217

United States, Missouri
Washington University in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Richard D Brasington, MD    314-454-7255   
Contact: Teresa A Arb, BSN    3147471217   
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Richard D Brasington, MD Washington U Rheumatology

Responsible Party: Washington University School of Medicine Identifier: NCT02769702     History of Changes
Other Study ID Numbers: Acthar Uveitis Study
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Washington University School of Medicine:

Additional relevant MeSH terms:
Uveitis, Anterior
Uveal Diseases
Eye Diseases
Iris Diseases
Adrenocorticotropic Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs