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Condition (MeSH)

Familial Mediterranean Fever

ClinicalTrials.gov lists 59 trials for Familial Mediterranean Fever or a narrower condition beneath it. Sheba Medical Center has the most among industry and government lead sponsors, with 5.

MeSH D010505 Congenital / Hereditary / Neonatal C16 Listed by Orphanet as a rare disease
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Phase 1 Phase 1 1 Phase 2 Phase 2 8 Phase 2/3 Phase 2/3 1 Phase 3 Phase 3 2 Phase 4 Phase 4 2 Not applicable Not applicable 14 Observational Observational 31 Phase 1 Phase 1 1 Phase 2 Phase 2 8 Phase 2/3 Phase 2/3 1 Phase 3 Phase 3 2 Phase 4 Phase 4 2 Not applicable Not applicable 14 Observational Observational 31

Trials per phase (log scale)

59 of the 59 trials are tagged with Familial Mediterranean Fever itself; the rest are tagged with a narrower condition beneath it.

Get the Familial Mediterranean Fever report as a PDF

The PDF carries up to 50 rows of each section, where the page shows the first few, with the sources listed. Enter a work email and confirm it from the message we send, and the report follows by email.

When did Familial Mediterranean Fever trials start? (20)

Shown in this order: most recent first, 1990 onwards. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Trials over time, by phase

  • Phase 1
  • Phase 2
  • Phase 2/3
  • Phase 3
  • Phase 4
  • Not applicable
  • Observational

Top of scale: 11

1994: 1 trials (Observational 1) 2001: 1 trials (Phase 2/3 1) 2004: 1 trials (Phase 2 1) 2007: 1 trials (Observational 1) 2008: 2 trials (Observational 1, Phase 2 1) 2009: 1 trials (Observational 1) 2010: 3 trials (Observational 1, Phase 2 1, Phase 1 1) 2011: 1 trials (Phase 4 1) 2012: 1 trials (Phase 3 1) 2013: 1 trials (Not applicable 1) 2014: 1 trials (Phase 2 1) 2018: 6 trials (Observational 4, Not applicable 1, Phase 2 1) 2019: 1 trials (Not applicable 1) 2020: 1 trials (Not applicable 1) 2021: 4 trials (Observational 2, Phase 2 2) 2022: 5 trials (Observational 2, Not applicable 2, Phase 2 1) 2023: 3 trials (Observational 2, Not applicable 1) 2024: 7 trials (Observational 5, Not applicable 1, Phase 3 1) 2025: 11 trials (Observational 6, Not applicable 5)

Trials registered with a start date in each year, 1990 onward, stacked by phase (complete years only; the current partial year is in the table's notes). The table below lists the same counts, most recent years first.

Trials started per year
Year Trials started
2026 (partial year) 7
2025 11
2024 7
2023 3
2022 5
2021 4
2020 1
2019 1
2018 6
2014 1

Forecast of the full-year count, planned starts included, not rows of this table: about 10 trials starting in 2026 and about 11 in 2027, the average of the 24 months through September, counted as registered and carried forward. The rows of this table count trials registered so far with a start date in the year, planned starts included; the forecast looks ahead to the count for the whole year, so it is not the same measure. In backtests on conditions of this size, forecasts made part-way through the year were typically off by about 28 percent and ran about 20 percent low against the count later registered; forecasts made before the year began were off by about 39 percent and ran about 37 percent low against the count later registered. These figures rest on a few years of history (target years from 2018 to 2025, varying by figure), place each condition as it is mapped today rather than as it was then, and score against a count for the newest year that was still being revised. Only condition series were scored.

Recruitment duration, a model prediction: 3 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

What phase are Familial Mediterranean Fever trials in? (7)

Shown in this order: phase order.

Show the trials by phase as a table
Trials by phase
Phase Trials
Phase 1 1
Phase 2 8
Phase 2/3 1
Phase 3 2
Phase 4 2
Not applicable 14
Observational 31

How many Familial Mediterranean Fever trials are recruiting? (8)

Shown in this order: the order a trial moves through, from not yet recruiting to unknown.

Trials by recruitment status
Status Trials
Not yet recruiting 11
Recruiting 11
Enrolling by invitation 2
Active, not recruiting 3
Completed 18

Status as registered on ClinicalTrials.gov. Each trial is counted once.

Which lead sponsors run the most Familial Mediterranean Fever trials? (5)

Shown in this order: most trials first. Lead sponsors the registry classes as industry, NIH, US federal, other government or network. A hospital or university the registry files as government can appear here. Sponsors it classes as academic or other are shown on the full page, because that class cannot separate an institution from a named investigator.

Lead sponsors
Sponsor Trials
Sheba Medical Center 5
Novartis Pharmaceuticals 3
Bursa City Hospital 2
R-Pharm International, LLC 2
Aristea Therapeutics, Inc. 1

Which drugs are being tested for Familial Mediterranean Fever? (3)

Shown in this order: most trials first. One row per drug, matched to a single molecule under all its names, ranked by number of trials.

Drugs tested
Drug Trials
RPH - 104 2
Rilonacept 2
RIST4721 1

Interventions as named in the registry (11)

Shown in this order: most trials first.

Interventions as named in the registry
Drug Trials
Anakinra alone (stages 2b/3) 3
Colchicines 2
NC-503 (Anti-amyloidotic (AA) Agent) 1
Canakinumab, ACZ885 1
Probiotic 1

These are the names sponsors entered on ClinicalTrials.gov that we have not matched to a single molecule. Some are drugs under a brand or code name; others are procedures, doses or arm labels.

Which serious adverse events do Familial Mediterranean Fever trials report? (10)

Shown in this order: most subjects affected first. Subjects affected summed across trials, a cross-trial signal, not a rate.

Serious adverse events in this condition's trials
Adverse event Subjects affected Trials
Hospitalization for FMF attack 4 1
Renal Calculi 2 1
Blood and lymphatic system disorders - Other (Macrophage Activation Syndrome) 1 1
Cerebrospinal fluid leakage 1 1
Joint infection-mycobacterium 1 1

Which publications cover Familial Mediterranean Fever? (67)

Shown in this order: major-topic papers first, then newest, then most linked to trials.

Publications
Publication Journal Year Major topic
Predictors of proteinuria, amyloidosis and kidney failure in familial Mediterranean fever: data from the International AIDA Network Registry. Rheumatology (Oxford, England) 2025 Yes
An Update on Familial Mediterranean Fever. International journal of molecular sciences 2023 Yes
Does Age at Onset Affect the Clinical Presentation of Familial Mediterranean Fever in Children? Journal of clinical rheumatology : practical reports on rheumatic & musculoskeletal diseases 2022 Yes
Familial Mediterranean Fever and Diet: A Narrative Review of the Scientific Literature. Nutrients 2022 Yes
Anakinra-Associated Amyloidosis. JAMA dermatology 2022 Yes

Prevalence (18)

Shown in this order: jurisdiction, then disease name. Orphanet observation for the mapped ORPHA concept; the mapping relation column says whether that concept is exactly this condition or broader or narrower.

Prevalence
Orphanet disease Type Class Geography Jurisdiction Mapping relation
Familial Mediterranean fever Point prevalence 1-9 / 1 000 000 Japan Not stated Unspecified
Familial Mediterranean fever Point prevalence >1 / 1000 Armenia Not stated Unspecified
Familial Mediterranean fever Point prevalence 1-9 / 1 000 000 Japan Not stated Exact
Familial Mediterranean fever Point prevalence 1-9 / 100 000 Sweden Not stated Unspecified
Familial Mediterranean fever Point prevalence 1-9 / 100 000 Sweden Not stated Exact

Rare-disease identity (2)

Shown in this order: exact, broader, narrower, other.

Rare-disease identity
Orphanet disease ORPHA code Relation Source
Familial Mediterranean fever 342 Exact Orphadata Science knowledge files, Product 1
Familial Mediterranean fever 342 Exact Orphanet Rare Disease Ontology (ORDO)

Not on this page

Not measured: delivery record.

Checked, with nothing recorded for this condition: sub-conditions in mesh.

Browse all condition evidence pages