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Cell Surface Marker Expression in Autoimmune Diseases (CASCADE)

A

Alpine Immune Sciences

Status

Completed

Conditions

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

Study type

Observational

Funder types

Industry

Identifiers

NCT03757065
ALPN000-001

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

14 participants in 7 patient groups

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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