Crohn's Disease, Inflammatory Myositis, Multiple Sclerosis, Sjogren's Syndrome, Systemic Lupus Erythematosus, Systemic Sclerosis, Ulcerative Colitis
Conditions
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.
Interventions
None listed
Sponsors
Alpine Immune Sciences, Inc.
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CD28 Expression | At enrollment | Percentage of CD28+ T cells in peripheral blood |
| ICOS Expression | At enrollment | Percentage of ICOS+ T cells in peripheral blood |
Countries
Canada
Outcome results
None listed