Trial · NCT06838143
Ilaris NIS in Korea
NCT06838143, Recruiting, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ilaris NIS in Korea. Trials, record NCT06838143. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06838143
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ilaris NIS in Korea
- NCT number
- NCT06838143
- Status
- Recruiting
- Enrollment
- 25 participants, estimated
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
Hereditary Periodic Fever Syndromes, Cryopyrin-associated Periodic Syndromes (CAPS), Colchicine Resistance Familial Mediterranean Fever (crFMF), TNF Receptor Associated Periodic Syndrome (TRAPS), Hyper-IgD Syndrome / Mevalonate Kinase Deficiency (HIDS/MKD), Systemic Juvenile Idiopathic Arthritis (sJIA)
- Interventions
- Ilaris
- First posted
- 2025-02-20
- Last updated
- 2026-05-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of adverse events and serious adverse events | Up to 104 weeks from Ilaris treatment | Adverse events and serious adverse events in hereditary periodic fever syndrome (CAPS, crFMF, TRAPS and HIDS/MKD) and sJIA patients treated with Ilaris. |
| Secondary | Proportion of complete responders | Up to 16 weeks from Liars treatment | Defining patients as responders when they are assessed as having achieved complete response at 4 weeks of treatment and reach 16 weeks of treatment without flare for crFMF, TRAPS, HIDS/MKD and sJIA patients or complete response at 8 weeks of treatment and reach 16 weeks of treatment without flare for CAPS patients. Complete response will be evaluated in patients with data of clinical response as measured by Physician Global Assessment of Disease Activity (PGA) (5-point scale of none, minor, mild, moderate and severe) Complete response is defined as meeting both of the following criteria. * PGA ≤ minor (PGA \< 2) (clinical response) * CRP ≤10 mg/L (= 1 mg/dL), or reduction by ≥70% from the start of treatment (serological response) Flare is defined as meeting both of the following criteria. * PGA ≥ mild (PGA ≥ 2) (clinical flare) * CRP \>30 mg/L (= 3 mg/dL) (serological flare) |
| Secondary | Proportion of participants with Physician Global Assessment of Disease Activity (PGA) score <2 | Up to 104 weeks from Ilaris treatment | Participants assessed by physician on Physician's Global Assessment measured on a 5--point scale for disease activity as: 0 = None/absent; 1 = Minor; 2 = Mild; 3 = Moderate; 4 = Severe. |
| Secondary | Proportion of patients with C- reactive protein (CRP) serological response | Up to 104 weeks from Ilaris treatment | Proportion of patients with a C-reactive protein (CRP) of ≤ 10 mg/L or a ≥ 70% decrease from the start of treatment. |
| Secondary | Proportions of patients with serum amyloid A (SAA) normalization | Up to 104 weeks from Ilaris treatment | Proportions of patients with serum amyloid A (SAA) normalization defined as SAA ≤ 10 mg/L. |
| Secondary | Proportion of patients classified in each severity level in the physician's severity assessment of key disease -specific signs and symptoms | Up to 104 weeks from Ilaris treatment | Physician's severity assessment of key disease-specific signs/symptoms uses the following 5- point scale. 0 = none 1. = minor 2. = mild 3. = moderate 4. = severe Key signs/symptoms to be assessed differ from disease to disease under study, which are as follows. CAPS: hearing impairment, visual impairment, renal impairment, and joint dysfunction, skin rash, injection site reaction crFMF: chest pain, abdominal pain, arthralgia/arthritis, skin rash TRAPS: skin rash, musculoskeletal pain, abdominal pain, eye manifestations HIDS (MKD): lymphadenopathy, aphthous ulcers, abdominal pain sJIA: arthritis, generalized lymphadenopathy, rheumatoid rash, hepatosplenomegaly or splenomegaly, serositis |
| Secondary | Proportions of patients classified in each severity level in symptoms likely to significantly affect affect physical functioning and vital prognosis | Up to 104 weeks from Ilaris treatment | Symptoms that may significantly affect physical functioning and vital prognosis will be evaluated using the following 5-point scale. 0 = none 1. = minor 2. = mild 3. = moderate 4. = severe Evaluation of auditory disorder, visual disorder and renal impairment, and status of central nervous system disorder |
| Secondary | Percent change from baseline in Health related quality of life (HRQOL) measured by Child Health Questionnaire-Parent Form 50 (CHQ-PF50) | Up to 104 weeks from Ilaris treatment | The CHQ is a generic self-administered instrument designed to capture the physical, emotional, and social components of health status of children. It comprises 15 health concepts (range, 0 to 100) exploring either physical and psychosocial domains. Higher scores in the scales indicate better HRQoL. |
| Secondary | Percent change from baseline in Health related quality of life (HRQOL) measured by 36-item Short Form Health Survey (SF-36) | Up to 104 weeks from Ilaris treatment | The SF-36 health survey is a subjective measure of health-related QoL and consists of 36 questions relating to eight domains: physical functioning, social functioning, physical role functioning, emotional role functioning, vitality, mental health, pain, and general health. Scores of each domain varies from 0 to 100 points, and a higher score represents better QoL |
| Secondary | Percent change from baseline in Health related quality of life (HRQOL) measured by Work Productivity and Activity Impairment Specific Health Problem v2.0 (WPAI-SHP) | Up to 104 weeks from Ilaris treatment | The WPAI-SHP contains six items relating to health problems interfering with work or daily activities over the previous week, the WPASI-SHP yields four scores, absenteeism, presenteeism, work productivity loss, and activity impairment, which can range from 0 (no impact on work/activities) to 100 (total incapacity). |
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/NCT06838143
GET https://conductscience.org/api/trials/v1/NCT06838143/registered