Type 1 Diabetes MellitusSRA01NCT01947036
T and B Cell Responses in Autoimmune Diseases
An observational study of Type 1 Diabetes Mellitus and Multiple Sclerosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
Trial summary
The study aims to establish whether defects in immune cell function are shared across multiple autoimmune diseases and whether those problems match to similar genes in the cells. Read more about this study
- Who is it for?
- Ages 8 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes Mellitus, Multiple Sclerosis, Arthritis, Rheumatoid
- How many people
- 68 participants
- Where
- 6 sitesUnited States
- Study dates
- Jan 2014to Oct 2015
- 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 8 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants who are healthy or have a confirmed or suspected diagnosis of type 1 diabetes (T1D, T1DM), multiple sclerosis (MS), psoriasis (Ps), Crohn's disease (CD), or rheumatoid arthritis (RA) will be invited to donate a blood sample. No follow-ups are planned.
Who may be able to join
- -Subject or subject's parent or legal guardian has provided written informed consent
- -For healthy donors: Healthy individuals between 18 and 60 years of age, inclusive
- For all subjects with an autoimmune disease:
- Adults between 18 and 60 years, inclusive, diagnosed with or suspected of having one of the following five diseases: adult forms of rheumatoid arthritis (RA), type 1 diabetes (T1D, T1DM), multiple sclerosis (MS), Crohn's disease (CD), Psoriasis (Ps)
- Or Children from 8 years up to 18 years inclusive, diagnosed with or suspected of having type 1 diabetes (TID) or Crohn's disease (CD)
- Treatment naïve except for prednisone (or equivalent corticosteroid) <\=10mg/day
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- 4. For subjects diagnosed with type 1 diabetes:
- <!-- -->
- Clinical diagnosis or suspected diagnosis of T1D
- Positive per standard clinical titer levels for anti-insulin antibodies if within 10 days of diagnosis (new-onset T1D); and otherwise one of the following antibodies-anti-GAD65, anti-ICA512/IA2 or anti-ZnT8
- Minimum body weight 17kg (≥37.5 pounds)
- Disease duration within 1 year
- 5. For subjects diagnosed with multiple sclerosis:
- EDSS (Expanded Disability Status Scale) 0-5 b. Diagnosis or suspected diagnosis of MS as per Dr. Polman et al. Annals of Neurology 2010 c. Disease duration within 1 year
- 6. For subjects diagnosed with rheumatoid arthritis (RA):
- Diagnosis or suspected diagnosis of RA (2010 ACR criteria) b. Anti-CCP antibody positive c. Disease duration within 1 year
- 7. For subjects diagnosed with Crohn's disease:
- Clinical diagnosis or suspected diagnosis of Crohn's confirmed by endoscopy b. Disease duration within 1 year c. Minimum body weight 17 kg (≥37.5 pounds)
- 8. For subjects diagnosed with psoriasis:
- Psoriasis diagnosis by a dermatologist
- Disease duration within 1 year
- At least two psoriatic plaques or a single plaque occupying at least 1% of total body surface outside scalp
Who cannot join
- 1. For healthy donors:
- Individuals who are unable or unwilling to donate blood samples b. Individuals with self-reported chronic metabolic diseases such as type 2 diabetes, impaired glucose tolerance or morbid obesity c. Individuals with self-reported acute infection (respiratory or others) or chronic infection (such as HIV,hepatitis B or -C) d. Individuals with self-reported immune-mediated diseases such as multiple sclerosis, type 1 diabetes, primary immunodeficiency e. Individuals with self-reported current or prior history of malignancy f. Individuals who are currently pregnant (self-report) g. Corticosteroid therapy equivalent to >/= 10 mg/day of prednisone within the last 4 weeks h. Immunosuppressive therapy at any time prior to enrollment (such as Cyclophosphamide, Mitoxantrone, Imuran, Cellcept, Methotrexate, Rituximab, Alemtuzumab)
- 2. For all subjects with an autoimmune disease:
- Pregnant patients b. Pediatric patients unable to donate at least 51 mL of blood per NIH guidelines (no more than 5 mL/kg in a single day and no more than 9.5 mL/kg over any 8 week period) c. Patients with current substance abuse or alcoholism (self-report) d. Patients diagnosed with more than one autoimmune and/or inflammatory disease, exception - asthma is permissible e. Corticosteroid therapy equivalent to > 10 mg/day of prednisone within the last 4 weeks f. Immunomodulatory therapies within the last 12 months (such as Interferon, Glatiramer Acetate, Natalizumab, Fingolimod) g. Immunosuppressive medication at any time prior to enrollment (such as Cyclophosphamide, Mitoxantrone, Imuran, Cellcept, Methotrexate, Rituximab, Alemtuzumab) h. Any prior or current Anti-tumor necrosis factor (anti-TNF) treatments i. Any prior or current use of experimental drugs tested in Phase I, II, or III clinical trials
- 3. Diagnosis of ulcerative colitis or indeterminate colitis
- 4. Pustular psoriasis, isolated palmoplantar psoriasis, isolated inverse psoriasis and isolated sebopsoriasis.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30322
Baylor Institute of Immunology Research - Clinical Rheumatology
Dallas, Texas, 75204
Feinstein Institute for Medical Research
Manhasset, New York, 11030
Yale University
New Haven, Connecticut, 06511
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, 73104
University of Rochester
Rochester, New York, 14642
About this study
Official title: T and B Cell Responses Across Autoimmune Diseases
The study aims to establish whether defects in immune cell function are shared across multiple autoimmune diseases and whether those problems match to similar genes in the cells.
Read the detailed description
This is a non-randomized, multi-center clinical research study. Subjects who are healthy or have a confirmed or suspected diagnosis of type 1diabetes, multiple sclerosis, psoriasis, Crohn's disease, or rheumatoid arthritis will be asked to donate a blood sample. No follow-ups are planned.
Investigators will:
- evaluate immune cells from subjects enrolled in this study and match the differences to types of immune cells known to cause autoimmune diseases
- investigate a particular disease pathway: the IL23R signaling cascade.
- Conditions
- Type 1 Diabetes Mellitus, Multiple Sclerosis, Arthritis, Rheumatoid, Crohn's Disease, Psoriasis
- Keywords
- autoimmune disease, immune-mediated disease, T and B cells immunophenotype, IL23 signaling, genetic risk variants
- Medical subject headings
- Diabetes Mellitus, Type 1, Multiple Sclerosis, Arthritis, Rheumatoid, Crohn Disease, Psoriasis, Autoimmune Diseases
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 |
|---|---|---|
| Healthy Subjects | Healthy adult controls (no auto-immune disease) | |
| Subjects with Crohn's Disease | Diagnosed with or suspected of having Crohn's disease (CD) | |
| Subjects with Rheumatoid Arthritis | Diagnosed with or suspected of having rheumatoid arthritis (RA) | |
| Subjects with Type 1 diabetes | Diagnosed with or suspected of having type 1 diabetes mellitus (T1D, T1DM) | |
| Subjects with Multiple Sclerosis (MS) | Diagnosed with or suspected of having MS | |
| Subjects with Psoriasis | Diagnosed with or suspected of having psoriasis (Ps) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify shared defects in T and B cell function by disease classification
The study aims to establish whether defects in T and B cell function are shared across multiple immune-mediated diseases and whether these are driven by shared genetic risk variants.
Measured: One-time blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: Lack of enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence
- Responsible party
- Sponsor
- Investigators
- Chris Cotsapas, PhD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947036
- Sponsor's protocol ID
- DAIT SRA01
- Acronym
- SRA01
- Status last verified
- Oct 2016
- First submitted
- 16 Sep 2013
- Last updated
- 26 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T and B Cell Responses Across Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT01947036
- Acronym / sponsor ID
- SRA01 / DAIT SRA01
- Conditions
- Type 1 Diabetes Mellitus, Multiple Sclerosis, Arthritis, Rheumatoid, Crohn's Disease, Psoriasis
- Keywords
- autoimmune disease, immune-mediated disease, T and B cells immunophenotype, IL23 signaling, genetic risk variants
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of enrollment.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- Autoimmunity Centers of Excellence
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Sep 2013 (estimated)
- 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.
The study aims to establish whether defects in immune cell function are shared across multiple autoimmune diseases and whether those problems match to similar genes in the cells.
Detailed description
This is a non-randomized, multi-center clinical research study. Subjects who are healthy or have a confirmed or suspected diagnosis of type 1diabetes, multiple sclerosis, psoriasis, Crohn's disease, or rheumatoid arthritis will be asked to donate a blood sample. No follow-ups are planned.
Investigators will:
- evaluate immune cells from subjects enrolled in this study and match the differences to types of immune cells known to cause autoimmune diseases
- investigate a particular disease pathway: the IL23R signaling cascade.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | – | –Healthy adult controls (no auto-immune disease) |
| Subjects with Crohn's Disease | – | –Diagnosed with or suspected of having Crohn's disease (CD) |
| Subjects with Rheumatoid Arthritis | – | –Diagnosed with or suspected of having rheumatoid arthritis (RA) |
| Subjects with Type 1 diabetes | – | –Diagnosed with or suspected of having type 1 diabetes mellitus (T1D, T1DM) |
| Subjects with Multiple Sclerosis (MS) | – | –Diagnosed with or suspected of having MS |
| Subjects with Psoriasis | – | –Diagnosed with or suspected of having psoriasis (Ps) |
Who may qualify
- Ages
- 8 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants who are healthy or have a confirmed or suspected diagnosis of type 1 diabetes (T1D, T1DM), multiple sclerosis (MS), psoriasis (Ps), Crohn's disease (CD), or rheumatoid arthritis (RA) will be invited to donate a blood sample. No follow-ups are planned.
Key inclusion criteria (22 listed)
- -Subject or subject's parent or legal guardian has provided written informed consent
- -For healthy donors: Healthy individuals between 18 and 60 years of age, inclusive
- For all subjects with an autoimmune disease:
- <!-- -->
Key exclusion criteria (6 listed)
- 3. Diagnosis of ulcerative colitis or indeterminate colitis
- 4. Pustular psoriasis, isolated palmoplantar psoriasis, isolated inverse psoriasis and isolated sebopsoriasis.
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
Identify shared defects in T and B cell function by disease classification
Time frame: One-time blood draw
The study aims to establish whether defects in T and B cell function are shared across multiple immune-mediated diseases and whether these are driven by shared genetic risk variants.
Results and safety
The study was stopped early (reason given: Lack of enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2016.
- National Institute of Allergy and Infectious Diseases (NIAID) websiteLink provided by the sponsor.
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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.
Chris Cotsapas, PhD principal investigator
Yale University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus and Multiple Sclerosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.
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 22 inclusion and 6 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: stopped early, as of the sponsor's last update on 26 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 was stopped early (reason given: Lack of enrollment.). Results are not available in the source record.
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?
Identify shared defects in T and B cell function by disease classification (time frame: One-time blood draw). 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 26 Oct 2016.