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Cell Surface Marker Expression in Autoimmune Diseases (CASCADE)

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ClinicalTrials.gov Identifier: NCT03757065
Recruitment Status : Not yet recruiting
First Posted : November 28, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : November 30, 2019
Estimated Study Completion Date : December 31, 2019


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



Primary Outcome Measures :
  1. CD28 Expression [ Time Frame: At enrollment ]
    Percentage of CD28+ T cells in peripheral blood

  2. ICOS Expression [ Time Frame: At enrollment ]
    Percentage of ICOS+ T cells in peripheral blood



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757065


Contacts
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Contact: Jan Hillson, MD 206-788-4545 jan.hillson@alpineimmunesciences.com

Sponsors and Collaborators
Alpine Immune Sciences, Inc.
Investigators
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Study Director: Jan Hillson, MD Alpine Immune Sciences

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Responsible Party: Alpine Immune Sciences, Inc.
ClinicalTrials.gov Identifier: NCT03757065     History of Changes
Other Study ID Numbers: ALPN000-001
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Crohn Disease
Colitis, Ulcerative
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Scleroderma, Diffuse
Sjogren's Syndrome
Myositis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Connective Tissue Diseases
Skin Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases