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

NCT07598045 | Not Yet Recruiting

• 1 other identifier: RNI 2025 MATHIEU
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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. Our 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.

Conditions

Migraine

Keywords

Migraine; Inflammation; Anti-IL-6 therapy; Chronic inflammatory rheumatic diseases

Outcome Measures

Primary Outcomes (1)

• Patient Global Impression of Change on migraine (frequency or intensity)

  Measure reduction in migraine under anti-IL-6, in terms of frequency or intensity, according to the PGI-C. Patients experiencing a reduction in migraine (in terms of frequency or intensity) will be defined as those who responded 0 (very much improved), 1 (much improved), or 2 (a little improved) on either the PGI-C frequency or the PGI-C intensity.

  Day 1

Secondary Outcomes (3)

• Patient Global Impression of Change on migraine (frequency)

  Day 1

• Patient Global Impression of Change on migraine (intensity)

  Day 1

• Patient Global Impression of Change on migraine (frequency and intensity)

  Day 1

Study Arms (2)

Anti-IL-6 group

Patient on anti-IL-6 therapy

Other: Migraine assessement

Anti-TNF group

Patients on anti-TNF therapy

Other: Migraine assessement

Interventions

Migraine assessement OTHER

Migraine frequency and intensity will be assessed in patients on anti-IL-6 (anti-IL-6 group) or anti-TNF (anti-TNF group) using the Patient Global Impression of Change score.

Anti-IL-6 group; Anti-TNF group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, France

Location

MeSH Terms

Conditions

Migraine Disorders; Inflammation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lise Laclautre

CONTACT

0473754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): May 26, 2026
• Primary Completion (Estimated): May 26, 2027
• Study Completion (Estimated): May 26, 2027
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

FR (1)