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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.

Tracking Information
First Submitted Date November 27, 2018
First Posted Date November 28, 2018
Last Update Posted Date April 8, 2019
Estimated Study Start Date May 1, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 27, 2018)
  • CD28 Expression [ Time Frame: At enrollment ]
    Percentage of CD28+ T cells in peripheral blood
  • ICOS Expression [ Time Frame: At enrollment ]
    Percentage of ICOS+ T cells in peripheral blood
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03757065 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Cell Surface Marker Expression in Autoimmune Diseases
Official Title A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Systemic Lupus Erythematosus
  • Sjogren's Syndrome
  • Multiple Sclerosis
  • Systemic Sclerosis
  • Crohn's Disease
  • Ulcerative Colitis
  • Inflammatory Myositis
Intervention Not Provided
Study Groups/Cohorts
  • Systemic Lupus Erythematosus
  • Sjogren's Syndrome
  • Multiple Sclerosis
  • Systemic Sclerosis
  • Crohn's Disease
  • Ulcerative Colitis
  • Inflammatory Myositis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: November 27, 2018)
90
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2019
Estimated Primary Completion Date November 30, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jan Hillson, MD 206-788-4545 jan.hillson@alpineimmunesciences.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03757065
Other Study ID Numbers ALPN000-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Alpine Immune Sciences, Inc.
Study Sponsor Alpine Immune Sciences, Inc.
Collaborators Not Provided
Investigators
Study Director: Jan Hillson, MD Alpine Immune Sciences
PRS Account Alpine Immune Sciences, Inc.
Verification Date April 2019