Efficacy of Anti-IL-6 Treatments on Migraine in Patients Treated With Anti-IL-6 for a Rheumatological Condition (RHUMIL-6)
調査の概要
詳細な説明
In this study, the investigators aim to measure the proportion of patients experiencing a reduction in migraine among those treated with anti-IL-6 therapy for their rheumatological condition, in terms of migraine frequency or intensity (primary objective). The secondary objectives are to :
- Measure the proportion of patients experiencing a reduction in migraine among those treated with anti-IL-6 therapy for their rheumatological condition, in terms of (a) frequency, (b) intensity, (c) both frequency and intensity of migraines.
- Compare the proportion of patients experiencing a reduction in migraine in terms of frequency or intensity between those treated with anti-IL-6 and a group of patients treated with anti-TNF (tumor necrosis factor) therapy.
From a pre-established list compiled by the investigators of patients on anti-IL-6 therapy (anti-IL-6 group) and patients on anti-TNF therapy (control group), all patients will be contacted by phone to identify those with migraine, using the International Classification of Headache Disorders, version 3 (ICHD-3) criteria from the International Headache Society (IHS). In cases where migraine is present, the effect of anti-IL-6 (anti-IL-6 group) or anti-TNF (control group) treatment in terms of the proportion of patients experiencing a reduction in migraine will be assessed using the Patient Global Impression of Change (PGI-C) score: a validated tool, widely used, translated into French and made available by eProvide - Mapi Research Trust [https://eprovide.mapi-trust.org/instruments/patient-global-impressions-scale-change-improvement-severity#need_this_questionnaire]) (comparison: before vs. during treatment). The episodic or chronic nature of migraine will be determined during the telephone interview according to the following criteria: fewer than 15 monthly headache days for episodic migraine, and at least 15 monthly headache days - of which at least 8 days have migrainous features - for chronic migraine (IHS definition). All patients on this list who meet the inclusion and non-inclusion criteria and agree to participate in the study will be enrolled. The inclusion of a control group - comprising patients treated with a biotherapy other than anti-IL-6, namely anti-TNF agents - will strengthen the level of attribution of the measured effect to anti-IL-6 treatment and help offset recall bias.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Lise Laclautre
- 電話番号:0473754963
- メール:promo_interne_drci@chu-clermontferrand.fr
研究場所
-
-
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Clermont-Ferrand、フランス
- CHU clermont-ferrand
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主任研究者:
- Sylvain MATHIEU
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コンタクト:
- Lise Laclautre
- 電話番号:0473754963
- メール:promo_interne_drci@chu-clermontferrand.fr
-
副調査官:
- Emily STUCHFIELD-DENBY
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria (for screening) :
- at least 18 years old
- ongoing or previous anti-IL-6 (anti-IL-6 group) or anti-TNF (anti-TNF group) therapy, taken for at least 3 months
Inclusion Criteria (patients to be enrolled) : migrainous patients, identified using the International Classification of Headache Disorders, version 3 (ICHD-3) criteria from the International Headache Society (IHS) during the telephone call
Exclusion Criteria:
- Biotherapy treatment in the context of a diagnosis of giant cell arteritis
- Verbal communication not possible
- No affiliation to the French national health insurance system, legal protection measure (guardianship, curatorship, judicial protection)
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 |
介入・治療 |
|---|---|
|
Anti-IL-6 group
Patient on anti-IL-6 therapy
|
Migraine frequency and intensity will be assessed in patients on anti-IL-6 (anti-IL-6 group) and anti-TNF (anti-TNF group).
Migraine frequency and intensity will be assessed in patients taking anti-IL-6 (anti-IL-6 group) and anti-TNF therapy (anti-TNF group) using the Patient Global Impression of Change (PGI-C) score.
|
|
Anti-TNF group
Patients on anti-TNF therapy
|
Migraine frequency and intensity will be assessed in patients on anti-IL-6 (anti-IL-6 group) and anti-TNF (anti-TNF group).
Migraine frequency and intensity will be assessed in patients taking anti-IL-6 (anti-IL-6 group) and anti-TNF therapy (anti-TNF group) using the Patient Global Impression of Change (PGI-C) score.
|
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 |
|---|---|---|
|
Patient Global Impression of Change (PGI-C) on migraine (frequency or intensity)
時間枠:Day 1
|
Measure change in migraine under anti-IL-6, in terms of frequency or intensity, according to the PGI-C score.
|
Day 1
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient Global Impression of Change on migraine (frequency)
時間枠:Day 1
|
Measure change in migraine under anti-IL-6, in terms of migraine frequency, according to the PGI-C score.
|
Day 1
|
|
Patient Global Impression of Change on migraine (intensity)
時間枠:Day 1
|
Measure change in migraine under anti-IL-6, in terms of migraine intensity, according to the PGI-C score.
|
Day 1
|
|
Patient Global Impression of Change on migraine (frequency and intensity)
時間枠:Day 1
|
Measure change in migraine under anti-IL-6, in terms of both frequency and intensity, according to the PGI-C scores.
|
Day 1
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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
キーワード
その他の研究ID番号
- RNI 2025 MATHIEU
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