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

ConditionMigraine
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Migraine assessement

    Other intervention

    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 intervention

    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.

Treatment groups

320 Participants
are divided into 2 treatment groups
Group A: Anti-IL-6 group2 interventions
Group B: Anti-TNF group2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Day 1

Secondary outcomes

1

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.

Time frame
Day 1
2

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.

Time frame
Day 1
3

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.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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