T and B Cell Responses in Autoimmune Diseases (SRA01)
T and B Cell Responses Across Autoimmune Diseases
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Connecticut
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New Haven、Connecticut、アメリカ、06511
- Yale University
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Georgia
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Atlanta、Georgia、アメリカ、30322
- Emory University
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New York
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Manhasset、New York、アメリカ、11030
- Feinstein Institute for Medical Research
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Rochester、New York、アメリカ、14642
- University of Rochester
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Oklahoma
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Oklahoma City,、Oklahoma、アメリカ、73104
- Oklahoma Medical Research Foundation
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Texas
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Dallas、Texas、アメリカ、75204
- Baylor Institute of Immunology Research - Clinical Rheumatology
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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:
- 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
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:
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:
- 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
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Healthy Subjects
Healthy adult controls (no auto-immune disease)
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Subjects with Crohn's Disease
Diagnosed with or suspected of having Crohn's disease (CD)
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Subjects with Rheumatoid Arthritis
Diagnosed with or suspected of having rheumatoid arthritis (RA)
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Subjects with Type 1 diabetes
Diagnosed with or suspected of having type 1 diabetes mellitus (T1D, T1DM)
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Subjects with Multiple Sclerosis (MS)
Diagnosed with or suspected of having MS
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Subjects with Psoriasis
Diagnosed with or suspected of having psoriasis (Ps)
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Identify shared defects in T and B cell function by disease classification
時間枠:One-time blood draw
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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.
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One-time blood draw
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協力者と研究者
捜査官
- 主任研究者:Chris Cotsapas, PhD、Yale University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- DAIT SRA01
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。