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Efficacy of Anti-IL-6 Treatments on Migraine in Patients Treated With Anti-IL-6 for a Rheumatological Condition (RHUMIL-6)

2 juni 2026 bijgewerkt door: University Hospital, Clermont-Ferrand
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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

320

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

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.

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
Anti-IL-6 group
Patient on anti-IL-6 therapy
Ander: 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).
Ander: 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.
Anti-TNF group
Patients on anti-TNF therapy
Ander: 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).
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Global Impression of Change (PGI-C) on migraine (frequency or intensity)
Tijdsspanne: Day 1
Measure change in migraine under anti-IL-6, in terms of frequency or intensity, according to the PGI-C score.
Day 1

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Patient Global Impression of Change on migraine (frequency)
Tijdsspanne: 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)
Tijdsspanne: 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)
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University Hospital, Clermont-Ferrand

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

26 mei 2026

Primaire voltooiing (Geschat)

26 mei 2027

Studie voltooiing (Geschat)

26 mei 2027

Studieregistratiedata

Eerst ingediend

13 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 mei 2026

Eerst geplaatst (Werkelijk)

20 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • RNI 2025 MATHIEU

Plan Individuele Deelnemersgegevens (IPD)

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