Trial · NCT06336733
Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy
NCT06336733, Phase 3, Recruiting, Assistance Publique - Hôpitaux de Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy. Trials, record NCT06336733. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06336733
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Randomized Controlled Trial in Patients on Long-term Colchicine With Colchicine-resistant Familial Mediterranean Fever (FMF) to Evaluate the Efficacy of On-demand Anakinra Treatment for Painful Attacks in Patients Who Refuse Continuous Daily Therapy
- NCT number
- NCT06336733
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 50 participants, estimated
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Conditions
- FMF
- Interventions
- ANAKINRA
- First posted
- 2024-03-29
- Last updated
- 2025-06-25
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean number of FMF-attacks per month at 6 months of treatment. | At Months 0 (baseline), Month 1, Month 3 and Month 6 | * FMF attacks is defined by a painful (consensual definition) manifestation during 12 to 72 hours, in either : * abdomen (with features consistent with a diagnosis of peritonitis), * chest (with features consistent with a diagnosis of pleuritis), * joints (with features consistent with a diagnosis of lower extremity large joint monoarthritis), * skin (with features consistent with a diagnosis of erysipeloid rash) * The painful manifestation can be (or not) accompanied by fever of ≥ 38°C Patients will be asked to note the number of days of pain of each inflammatory attack on a diary. |
| Secondary | Cumulative days of FMF attack treatment from randomization to 6 months | At Months 0 (baseline), Month 1, Month 3 and Month 6 | The number of days of injections (for anakinra arm) or number of days of consumption of analgesics (for control group) will be collected via a notebook . Safety |
| Secondary | AIDAI (Auto-inflammatory Diseases activity index) score | At Months 0 (baseline), Month 1, Month 3 and Month 6 | Patients will complete the AIDAI (Auto-inflammatory Diseases activity index) score monthly. |
| Secondary | Number of painful days and severity of FMF attacks occurring between randomization and M6 | At Months 0 (baseline), Month 1, Month 3 and Month 6 | Number of painful days will be measured by VAS (Visual Analogue Scale) and collected via a notebook). |
| Secondary | Quality of life score measured by EuroQOL questionnaire (EQ-5D5L) | At Months 0 (baseline), Month 1, Month 3 and Month 6 | The EQ5D5L will be completed at each visit |
| Secondary | Number of local cutaneous reactions at 6 months (erythema and oedema involving the injection sites) in the anakinra arm | At Months 0 (baseline), Month 1, Month 3 and Month 6 | Number of local cutaneous reaction will be collected via a notebook |
| Secondary | Proportion of Adverse events | At Months 0 (baseline), Month 1, Month 3 and Month 6 | Adverse events will be collected via a notebook |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06336733
GET https://conductscience.org/api/trials/v1/NCT06336733/registered