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OpenTrials
Completed

NCT Number: NCT03757065

Cell Surface Marker Expression in Autoimmune Diseases

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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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female participants 19 years of age or older.
  • Participant or legal surrogate able and willing to provide written, informed consent.
  • 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.
  • Participant has or will provide the relevant peripheral blood (required) and normal practice tissue specimens (if available).
  • Participant has one of the following target auto-immune or inflammatory diseases diagnosed according to local clinical practice guidelines:
  • Crohn's Disease
  • Inflammatory myositis
  • Multiple sclerosis
  • Sjogren's syndrome
  • Systemic lupus erythematosus
  • Systemic sclerosis
  • Ulcerative colitis

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. CD28 Expression

    Time frame: At enrollment

    Percentage of CD28+ T cells in peripheral blood

  2. ICOS Expression

    Time frame: At enrollment

    Percentage of ICOS+ T cells in peripheral blood

Sponsors and collaborators

Lead sponsor

Alpine Immune Sciences, Inc.

Industry

Registry information

Official study title

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

Acronym: CASCADE

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2018
Registry last updated
Aug 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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