TWEAK, a New Biomarker for Predicting Inflammatory Relapses in Multiple Sclerosis (TWEAK)
多発性硬化症における炎症性スラストを予測する新しいバイオマーカーである TNF 関連アポトーシス誘導因子 (TWEAK)
A significant variation in the serum concentration of the circulating cytokine TWEAK is associated with the onset of an inflammatory attack of MS. Study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak.
調査の概要
詳細な説明
Multiple sclerosis (MS) is the most common chronic autoimmune demyelinating and neurodegenerative disease of the central nervous system (CNS) of disabling neurological diseases in young adults in France. Patients with MS can present a wide range of symptoms spread over time and space such as motor, sensory, visual or vesico-sphincter deficits. One of the current challenges in treating patients with symptoms suggestive of MS is to assess the risk of an inflammatory flare in order to avoid or limit the installation of an irreversible neurological handicap. At present, the inflammatory activity of the disease is evaluable only by cerebral imaging (MRI). However, these examinations can not be carried out as often as necessary because of their accessibility, cost, duration and the potential deleterious effects of gadolinium accumulation. This is why a blood biomarker able to report early on the inflammatory activity of the disease would be of great help during the monitoring and treatment of patients. TWEAK (TNF-related weak inducer of apoptosis or TNFSF12) is a pro-inflammatory cytokine member of the TNF family. This cytokine is overexpressed in tissues with chronic inflammatory diseases such as MS. It is produced by monocytes / macrophages and microglial cells and can exist in soluble or membrane form the investigators of the clinical department were the first to describe the pro-inflammatory role of TWEAK in MS. Indeed, the investigators have demonstrated in an animal model of MS that the inhibition of TWEAK makes it possible to reduce the severity of the disease. Their recent work (manuscript submitted for publication) has also shown results from a series of 28 patients with MS suggesting that the serum TWEAK assay may be an early marker of thrust occurrence. The investigators propose to study the concentration variations of the serum soluble form of cytokine TWEAK during the first year of MS and to analyze their correlation with the occurrence of an inflammatory disease outbreak. The investigators will perform a prospective study in which 50 patients with MS in the isolated clinical syndrome stage will be included over a 12-month period. Mental Cerebral MRIs will be performed for each patient at baseline (T0), month 6, and month 12. Serum dosages of TWEAK will be performed each month for each patient for one year. Patients will also be treated with soluble TNF, the leader in the TNF family of ligands, anti-TWEAK antibodies (which may interfere with the activity and dosage of TWEAK) as well as C-reactive Protein C ( search for intercurrent infectious episode). These dosages will be correlated with the clinical evolution (appearance or not of an inflammatory flare) as well as the data of the imagery (number of lesions raised or not by the gadolinium).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Sophie DESPLAT-JEGO
- 電話番号:+ 33 4 91 38 39 07
- メール:sophie.jego-desplat@ap-hm.fr
研究場所
-
-
-
Marseille、フランス、13354
- 募集
- Assistance Publique Hopitaux de Marseille
-
コンタクト:
- Sophie DESPLAT-JEGO, IP
- 電話番号:+33 04 91 38 39 07
- メール:promotion.interne@ap-hm.fr
-
-
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
説明
Inclusion Criteria:
- a first episode of inflammation and demyelination of the central nervous system affecting the optic nerve, the spinal cord, one cerebral hemisphere, or the brainstem; or confirmed multiple sclerosis
- no differential diagnosis at enrollment based on clinical examination and laboratory tests
- compliance with the revised 2017 Mac Donald diagnostic criteria
Exclusion Criteria:
- age <18 years old
- person in an emergency situation
- adult who is subject to a legal protection measure (an adult under guardianship, conservatorship, or judicial protection), or who is unable to give consent
- not Enrolled in a Social Security Program
- pregnant or breastfeeding woman
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
- 主な目的:他の
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の:serum concentration changes in cytokine TWEAK
We will perform a prospective study in which 50 patients with multiple sclerosis in the isolated clinical syndrome stage will be included over a 12-month period. Mental Cerebral MRIs will be performed for each patient at baseline (T0), month 6, and month 12. Serum dosages of TWEAK will be performed each month for each patient for one year. Patients will also be treated with soluble TNF, the leader in the TNF family of ligands, anti-TWEAK antibodies (which may interfere with the activity and dosage of TWEAK) as well as C-reactive Protein C ( search for intercurrent infectious episode). These dosages will be correlated with the clinical evolution (appearance or not of an inflammatory flare) as well as the data of the imagery (number of lesions raised or not by the gadolinium). |
Blood samples (20 ml of blood on dry tube) by venipuncture at the bend of the elbow will be made at T0, then monthly for a period of 1 year . The sera will be isolated by centrifugation and then frozen at -80 degrees Assays of the soluble form of TWEAK and TNF will be performed by ELISA blot technique developed by the team. |
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 |
|---|---|---|
|
The serum concentration of soluble TWEAK
時間枠:1 year
|
We will then compare the soluble TWEAK concentrations observed in patients with anti-TWEAK antibodies and in patients without anti-TWEAK antibodies. We will study the correlation between the concentrations of soluble TWEAK and those of soluble TNF. |
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The titers of anti-TWEAK antibodies
時間枠:1 year
|
Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample |
1 year
|
|
Functional properties of anti-TWEAK antibodies
時間枠:1 year
|
Positive or negative test Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample |
1 year
|
|
Soluble TWEAK concentrations
時間枠:1 year
|
Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample |
1 year
|
|
Serum concentrations of soluble TNF
時間枠:1 year
|
Measured via blood samples taken at baseline and then 3 to 6 times thereafter, with at least 1 month between each sample |
1 year
|
協力者と研究者
捜査官
- スタディディレクター:Jean-Olivier ARNAUD、Assistance Publique des Hôpitaux de Marseille
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- RCAPHM19_0158
- 2020-A00770-39 (その他の識別子:IDRCB)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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