Cell Surface Marker Expression in Autoimmune Diseases

NCT03757065 — Completed, 14 participants, Alpine Immune Sciences, Inc.

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A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases

Registry	NCT03757065, acronym CASCADE
Status	Completed
Study type	Observational
Enrollment	14 (Actual)
Sponsor	Alpine Immune Sciences, Inc. (Industry)
Conditions	Systemic Lupus Erythematosus, Sjogren's Syndrome, Multiple Sclerosis, Systemic Sclerosis, Crohn's Disease, Ulcerative Colitis, Inflammatory Myositis
Dates	start 2019-06-12, primary completion 2019-10-25, completion 2019-10-25, first posted 2018-11-28, last updated 2020-08-27
Locations	2 sites in Canada

-Summary

This study is designed to explore the expression of cell-surface markers in the following seven disease areas: (a) systemic lupus erythematosus, (b) Sjogren's syndrome, (c) multiple sclerosis, (d) systemic sclerosis, (e) Crohn's disease, (f) ulcerative colitis and (g) inflammatory myositis.

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+Arms and interventions

Arm	Type	Interventions	Description
Systemic Lupus Erythematosus
Sjogren's Syndrome
Multiple Sclerosis
Systemic Sclerosis
Crohn's Disease
Ulcerative Colitis
Inflammatory Myositis

+Outcome measures

Primary outcomes

CD28 Expression [At enrollment]: Percentage of CD28+ T cells in peripheral blood
ICOS Expression [At enrollment]: Percentage of ICOS+ T cells in peripheral blood

+Eligibility

Sex: All, ages: 19 Years to any

Inclusion Criteria:

1. Male or female participants 19 years of age or older.
2. Participant or legal surrogate able and willing to provide written, informed consent.
3. Participant is, or has been undergoing care for one of the specified diseases in a participating centre with a confirmed clinical diagnosis of the specified disease.
4. Participant has or will provide the relevant peripheral blood (required) and normal practice tissue specimens (if available).
5. Participant has one of the following target auto-immune or inflammatory diseases diagnosed according to local clinical practice guidelines:

   1. Crohn's Disease
   2. Inflammatory myositis
   3. Multiple sclerosis
   4. Sjogren's syndrome
   5. Systemic lupus erythematosus
   6. Systemic sclerosis
   7. Ulcerative colitis

Exclusion Criteria:

1. Participants receiving investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to enrolment.
2. Participants suffering from any additional disease that may interfere with the biomarker signals as per the investigator's discretion.

+Locations (2)

Facility	City	Country	Status
GI Research Institute	Vancouver, British Columbia	Canada
Mary Pack Arthritis Center	Vancouver	Canada

+Investigators

Jan Hillson, MD, Study director, Alpine Immune Sciences

My Notes

Public

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