Cell Surface Marker Expression in Autoimmune Diseases

Completed

• Conditions: Systemic Sclerosis; Crohn's Disease; Ulcerative Colitis; Sjogren's Syndrome; Systemic Lupus Erythematosus; Multiple Sclerosis; Inflammatory Myositis

• Registration Number: NCT03757065
• Lead Sponsor: Alpine Immune Sciences, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-27
• Study First Posted: 2018-11-28
• Study Start: 2019-06-12
• Primary Completion: 2019-10-25
• Study Completion: 2019-10-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-25
• Last Update Posted: 2020-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICOS Expression	At enrollment	Percentage of ICOS+ T cells in peripheral blood
CD28 Expression	At enrollment	Percentage of CD28+ T cells in peripheral blood

Trial Locations

Locations (2)

Mary Pack Arthritis Center; 🇨🇦 Vancouver, Canada

GI Research Institute; 🇨🇦 Vancouver, British Columbia, Canada