T and B Cell Responses in Autoimmune Diseases

Multiple Sclerosis Clinical Trial

— SRA01  

Official title:

T and B Cell Responses Across Autoimmune Diseases

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01947036
• Other study ID #: DAIT SRA01
• Status: Terminated
• Phase: N/A
• First received: September 16, 2013
• Last updated: October 24, 2016
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: October 2016
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 68
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 60 Years

Eligibility

Inclusion Criteria:

-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:

1. 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)

2. 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)

3. Treatment naïve except for prednisone (or equivalent corticosteroid) <\=10mg/day

4. For subjects diagnosed with type 1 diabetes:

1. Clinical diagnosis or suspected diagnosis of T1D

2. 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

3. Minimum body weight 17kg (=37.5 pounds)

4. Disease duration within 1 year

5. For subjects diagnosed with multiple sclerosis:

a. 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):

a. 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:

a. 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:

1. Psoriasis diagnosis by a dermatologist

2. Disease duration within 1 year

3. At least two psoriatic plaques or a single plaque occupying at least 1% of total body surface outside scalp

Exclusion Criteria:

1. For healthy donors:

a. 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:

a. 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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Arthritis, Rheumatoid
• Autoimmune Diseases
• Crohn Disease
• Crohn's Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Multiple Sclerosis
• Psoriasis
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Baylor Institute of Immunology Research - Clinical Rheumatology	Dallas	Texas
United States	Feinstein Institute for Medical Research	Manhasset	New York
United States	Yale University	New Haven	Connecticut
United States	Oklahoma Medical Research Foundation	Oklahoma City,	Oklahoma
United States	University of Rochester	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Autoimmunity Centers of Excellence

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One-time blood draw	No

External Links

•   Autoimmunity Centers of Excellence (ACE) website
•   National Institute of Allergy and Infectious Diseases (NIAID) website