[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638901":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":29,"interventions":40,"overallOfficials":23,"centralContacts":49,"locations":55,"responsibleParty":75,"collaborators":23,"id":77,"slug":23,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":23,"enrollmentInfo":85,"targetDuration":23,"studyType":88,"phases":23,"briefSummary":89,"conditions":90,"keywords":92,"overallStatus":96,"whyStopped":23,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"University Hospital, Clermont-Ferrand","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Patient Global Impression of Change (PGI-C) on migraine (frequency or intensity)","Measure change in migraine under anti-IL-6, in terms of frequency or intensity, according to the PGI-C score.","Day 1",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Patient Global Impression of Change on migraine (frequency)","Measure change in migraine under anti-IL-6, in terms of migraine frequency, according to the PGI-C score.",{"measure":18,"description":19,"timeFrame":12},"Patient Global Impression of Change on migraine (intensity)","Measure change in migraine under anti-IL-6, in terms of migraine intensity, according to the PGI-C score.",{"measure":21,"description":22,"timeFrame":12},"Patient Global Impression of Change on migraine (frequency and intensity)","Measure change in migraine under anti-IL-6, in terms of both frequency and intensity, according to the PGI-C scores.",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":25,"timePerspective":26,"maskingInfo":23},"CASE_CONTROL","PROSPECTIVE","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 :\n\n* 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.\n* 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.\n\nFrom 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:\u002F\u002Feprovide.mapi-trust.org\u002Finstruments\u002Fpatient-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.","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, will complete the Patient Global Impression of Change (PGI-C) score to determine whether the treatment (anti-IL-6 or anti-TNF) is associated with a reduction in migraines or not.",[30,36],{"label":31,"type":23,"description":32,"interventionNames":33},"Anti-IL-6 group","Patient on anti-IL-6 therapy",[34,35],"Other: Migraine assessement","Other: Patient Global Impression of Change",{"label":37,"type":23,"description":38,"interventionNames":39},"Anti-TNF group","Patients on anti-TNF therapy",[34,35],[41,45],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":23},"Migraine assessement","Migraine frequency and intensity will be assessed in patients on anti-IL-6 (anti-IL-6 group) and anti-TNF (anti-TNF group).",[31,37],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":23},"Patient Global Impression of Change","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.",[31,37],[50],{"name":51,"role":52,"phone":53,"phoneExt":23,"email":54},"Lise Laclautre","CONTACT","0473754963","promo_interne_drci@chu-clermontferrand.fr",[56],{"facility":57,"status":23,"city":58,"state":23,"zip":23,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Chu Clermont-Ferrand","Clermont-Ferrand","France","FR",{"type":62,"coordinates":63},"Point",[64,65],3.08682,45.77969,{"lat":65,"lon":64},[68,69,72],{"name":51,"role":52,"phone":53,"phoneExt":23,"email":54},{"name":70,"role":71,"phone":23,"phoneExt":23,"email":23},"Sylvain MATHIEU","PRINCIPAL_INVESTIGATOR",{"name":73,"role":74,"phone":23,"phoneExt":23,"email":23},"Emily STUCHFIELD-DENBY","SUB_INVESTIGATOR",{"type":76,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100638901",false,"NCT07598045","Efficacy of Anti-IL-6 Treatments on Migraine in Patients Treated With Anti-IL-6 for a Rheumatological Condition","RHUMIL-6","Inclusion Criteria (for screening) :\n\n* at least 18 years old\n* ongoing or previous anti-IL-6 (anti-IL-6 group) or anti-TNF (anti-TNF group) therapy, taken for at least 3 months\n\nInclusion 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\n\nExclusion Criteria:\n\n* Biotherapy treatment in the context of a diagnosis of giant cell arteritis\n* Verbal communication not possible\n* No affiliation to the French national health insurance system, legal protection measure (guardianship, curatorship, judicial protection)","ALL","18 Years",{"count":86,"type":87},320,"ESTIMATED","OBSERVATIONAL","Migraine affects approximately 15% of the global population. Its prevalence doubles or even triples in individuals with chronic inflammatory conditions, such as chronic inflammatory rheumatic diseases (34%), multiple sclerosis (MS) (46%), or endometriosis (35%). The prevalence of chronic migraine - defined as at least 15 headache days per month (on average over the past 3 months), of which at least 8 days have migrainous features - is also higher in certain conditions such as MS (4%) compared to the general population (1%). The mechanisms underlying migraine and its chronification remain uncertain, but inflammation appears to play an important role in its pathophysiology: it is present from the onset of a migraine attack, represented by the release of pro-inflammatory cytokines that sensitize the trigeminal system and promote the occurrence of new attacks. The investigators' recent bibliographic work has demonstrated elevated levels of interleukin-6 (IL-6), a pro-inflammatory cytokine, in the blood of episodic migraine patients between attacks (migrainous status) compared to non-migrainous subjects, and in chronic migraine patients compared to episodic migraine patients (chronic migraine status). IL-6 appears to play a role in the pathophysiology of migraine, and elevated levels may represent a marker of poorer response to prophylactic treatments. IL-6 levels are also elevated in inflammatory rheumatic diseases and are associated with disease severity. The efficacy of IL-6 pathway-blocking treatments in inflammatory rheumatic diseases is now well established, and these agents are commonly used for this indication. IL-6 could therefore represent a shared pathophysiological link between migraine and inflammatory rheumatic diseases. However, no study to date has measured the effect of IL-6-blocking treatments on migraine. This study therefore aims to assess the effect of anti-IL-6 treatments on migraine in migrainous patients followed in the rheumatology department of the Clermont-Ferrand University Hospital and treated with anti-IL-6 therapy for their rheumatological condition (rheumatoid arthritis, polymyalgia rheumatica, etc.). It will provide preliminary results regarding the effect of anti-IL-6 agents on migraine and could justify future therapeutic studies.",[91],"Migraine",[91,93,94,95],"Inflammation","Anti-IL-6 therapy","Chronic inflammatory rheumatic diseases","NOT_YET_RECRUITING","2026-06-02",{"date":99,"type":100},"2026-06-04","ACTUAL",{"date":102,"type":87},"2026-05-26",{"date":104,"type":87},"2027-05-26",{"name":5,"class":6},1]