Cell Surface Marker Expression in Autoimmune Diseases (CASCADE)

August 25, 2020 updated by: Alpine Immune Sciences, Inc.

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Vancouver, Canada
        • Mary Pack Arthritis Center
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, multiple sclerosis, Crohn's disease, ulcerative colitis, or inflammatory myositis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Crohn's Disease
Multiple Sclerosis
Ulcerative Colitis
Systemic Lupus Erythematosus
Sjogren's Syndrome
Systemic Sclerosis
Inflammatory Myositis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CD28 Expression
Time Frame: At enrollment
Percentage of CD28+ T cells in peripheral blood
At enrollment
ICOS Expression
Time Frame: At enrollment
Percentage of ICOS+ T cells in peripheral blood
At enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alpine Immune Sciences, Inc.

Investigators

  • Study Director: Jan Hillson, MD, Alpine Immune Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2019

Primary Completion (Actual)

October 25, 2019

Study Completion (Actual)

October 25, 2019

Study Registration Dates

First Submitted

November 27, 2018

First Submitted That Met QC Criteria

November 27, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALPN000-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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