Systemic Lupus ErythematosusCASCADENCT03757065
Cell Surface Marker Expression in Autoimmune Diseases
An observational study of Systemic Lupus Erythematosus and Sjogren's Syndrome, run by Alpine Immune Sciences, Inc. at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Sjogren's Syndrome, Multiple Sclerosis
- How many people
- 14 participants
- Where
- 2 sitesCanada
- Study dates
- 12 Jun 2019to 25 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, multiple sclerosis, Crohn's disease, ulcerative colitis, or inflammatory myositis.
Who may be able to join
- 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
Show all 12Show fewer
- Inflammatory myositis
- Multiple sclerosis
- Sjogren's syndrome
- Systemic lupus erythematosus
- Systemic sclerosis
- Ulcerative colitis
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
GI Research Institute
Vancouver, British Columbia, V6Z 2K5
Mary Pack Arthritis Center
Vancouver
About this study
Official title: A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases
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
- Medical subject headings
- Lupus Erythematosus, Systemic, Sjogren's Syndrome, Multiple Sclerosis, Scleroderma, Systemic, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Systemic Lupus Erythematosus | Not described | |
| Sjogren's Syndrome | Not described | |
| Multiple Sclerosis | Not described | |
| Systemic Sclerosis | Not described | |
| Crohn's Disease | Not described | |
| Ulcerative Colitis | Not described | |
| Inflammatory Myositis | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD28 Expression
Percentage of CD28+ T cells in peripheral blood
Measured: At enrollment
ICOS Expression
Percentage of ICOS+ T cells in peripheral blood
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start12 Jun 2019
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alpine Immune Sciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Hillson, MD, Study director, Alpine Immune Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757065
- Sponsor's protocol ID
- ALPN000-001
- Acronym
- CASCADE
- Status last verified
- Aug 2020
- First submitted
- 27 Nov 2018
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-Sectional Study of Cell Surface Marker Expression in Participants With Autoimmune or Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT03757065
- Acronym / sponsor ID
- CASCADE / ALPN000-001
- Conditions
- Systemic Lupus Erythematosus, Sjogren's Syndrome, Multiple Sclerosis, Systemic Sclerosis, Crohn's Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Alpine Immune Sciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jun 2019 (actual)
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Systemic Lupus Erythematosus | – | – |
| Sjogren's Syndrome | – | – |
| Multiple Sclerosis | – | – |
| Systemic Sclerosis | – | – |
| Crohn's Disease | – | – |
| Ulcerative Colitis | – | – |
| Inflammatory Myositis | – | – |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with systemic lupus erythematosus, Sjogren's syndrome, systemic sclerosis, multiple sclerosis, Crohn's disease, ulcerative colitis, or inflammatory myositis.
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Hillson, MD study director
Alpine Immune Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Sjogren's Syndrome, run by Alpine Immune Sciences, Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD28 Expression (time frame: At enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.