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

Sponsor
University Hospital, Clermont-Ferrand
Study ID
NCT07598045
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Migraine assessement — OTHER
    Migraine frequency and intensity will be assessed in patients on anti-IL-6 (anti-IL-6 group) and anti-TNF (anti-TNF group).
  • Patient Global Impression of Change — OTHER
    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.

Study Details

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.

Key Dates

First listed
May 20, 2026
Start date
May 26, 2026
Status verified
May 2026
Primary completion
May 26, 2027
Completion
May 26, 2027

Study Design

Enrollment
320 participants (estimated)

Arms

  • Arm: Anti-IL-6 group
    Patient on anti-IL-6 therapy
  • Arm: Anti-TNF group
    Patients on anti-TNF therapy

Primary Outcome Measure

Patient Global Impression of Change (PGI-C) on migraine (frequency or intensity) [ Time Frame: Day 1 ]

Central Contacts

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