Cell Surface Marker Expression in Autoimmune Diseases

NCT03757065 | Completed

• 1 other identifier: ALPN000-001
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• CD28 Expression

  Percentage of CD28+ T cells in peripheral blood

  At enrollment

• ICOS Expression

  Percentage of ICOS+ T cells in peripheral blood

  At enrollment

Study Arms (7)

Systemic Lupus Erythematosus

Sjogren's Syndrome

Multiple Sclerosis

Systemic Sclerosis

Crohn's Disease

Ulcerative Colitis

Inflammatory Myositis

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alpine Immune Sciences, Inc.: lead

Study Sites (2)

GI Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Mary Pack Arthritis Center

Vancouver, Canada

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Sjogren's Syndrome; Multiple Sclerosis; Scleroderma, Systemic; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Skin Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Jan Hillson, MD

  Alpine Immune Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 28, 2018
• Study Start: June 12, 2019
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: August 27, 2020

Record last verified: 2020-08

Locations

CA (2)