Cell Surface Marker Expression in Autoimmune Diseases

Multiple Sclerosis Clinical Trial

— CASCADE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03757065
• Other study ID #: ALPN000-001
• Status: Completed
• Start date: June 12, 2019
• Est. completion date: October 25, 2019

Study information

• Verified date: August 2020
• Source: Alpine Immune Sciences, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease
• Inflammatory Myositis
• Lupus Erythematosus, Systemic
• Multiple Sclerosis
• Myositis
• Scleroderma, Systemic
• Sclerosis
• Sjogren's Syndrome
• Systemic Lupus Erythematosus
• Systemic Sclerosis
• Ulcerative Colitis

Locations

Country	Name	City	State
Canada	GI Research Institute	Vancouver	British Columbia
Canada	Mary Pack Arthritis Center	Vancouver

Sponsors (1)

Lead Sponsor	Collaborator
Alpine Immune Sciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CD28 Expression	Percentage of CD28+ T cells in peripheral blood	At enrollment
Primary	ICOS Expression	Percentage of ICOS+ T cells in peripheral blood	At enrollment