Efficacy of Anti-IL-6 Treatments on Migraine in Patients Treated With Anti-IL-6 for a Rheumatological Condition (RHUMIL-6)
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Lise Laclautre
- 电话号码:0473754963
- 邮箱:promo_interne_drci@chu-clermontferrand.fr
学习地点
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Clermont-Ferrand、法国
- CHU clermont-ferrand
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首席研究员:
- Sylvain MATHIEU
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接触:
- Lise Laclautre
- 电话号码:0473754963
- 邮箱:promo_interne_drci@chu-clermontferrand.fr
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副研究员:
- Emily STUCHFIELD-DENBY
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Anti-IL-6 group
Patient on anti-IL-6 therapy
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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.
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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.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Global Impression of Change (PGI-C) on migraine (frequency or intensity)
大体时间:Day 1
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Measure change in migraine under anti-IL-6, in terms of frequency or intensity, according to the PGI-C score.
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Day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Patient Global Impression of Change on migraine (frequency)
大体时间: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)
大体时间: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)
大体时间: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
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- RNI 2025 MATHIEU
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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