Trial · NCT04717635
Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD
NCT04717635, Phase 3, Completed, Novartis Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD. Trials, record NCT04717635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04717635
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Canakinumab in Japanese Patients With AOSD
- NCT number
- NCT04717635
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 14 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Adult Onset Still's Disease
- Interventions
- Canakinumab
- First posted
- 2021-01-22
- Last updated
- 2026-03-31
- Other registries' IDs
- eudract:2021-003706-50
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Adapted American College of Rheumatology (ACR) 30 Response at Week 8 | Baseline, Week 8 | Adapted ACR30 response was defined as a ≥30% improvement from baseline in at least 3 of the following 5 core response variables, with no more than one of these variables worsening by \>30%: 1. Physicians global assessment of disease activity (PhGA) on a 0-100 mm visual analogue scale (VAS) (0=very good and 100=very poor). 2. Participant's assessment of disease activity (PtGA) on a 0-100 mm VAS (0=very good and 100=very poor). 3. Health Assessment Questionnaire- disability index (HAQ-DI): 20 questions across 8 domains assessing the functional abilities. The total score was calculated as the average of the scores for each domain, ranging from 0 (no disability) to 3 (very severe disability). 4. Number of active joints (68 joints evaluated for pain/tenderness and 66 for swelling) 5. Index of inflammation: C-reactive Protein (CRP) levels Additionally, participants were required to have no intermittent fever during the preceding week. |
| Secondary | Number of Participants Who Were Able to Taper Corticosteroids Based on Success Criteria at Week 28. | Baseline, Week 28 | Number of participants achieving successful corticosteroid tapering at Week 28 was assessed. Successful tapering was defined as meeting any one of the following criteria and maintaining a minimum Adapted ACR30 response: * Participants with a baseline prednisone equivalent dose \> 0.8 mg/kg/day must reduce to ≤ 0.5 mg/kg/day * Participants with a baseline dose between ≥ 0.5 and ≤ 0.8 mg/kg/day must reduce by ≥ 0.3 mg/kg/day * Participants with any baseline dose must reduce to ≤ 0.2 mg/kg/day * Participants with a baseline dose ≤ 0.2 mg/kg/day must achieve any reduction The Adapted ACR30 response requires ≥30% improvement in at least 3 of the following 5 variables, with no more than one worsening by \>30%, and no intermittent fever in the preceding week: 1. PhGA \[0-100 VAS\] 2. PtGA \[0-100 VAS\] 3. HAQ-DI \[0-3 scale\] 4. Number of active joints (pain/tenderness: 0-68; swelling: 0-66) 5. CRP levels |
| Secondary | Number of Participants Who Achieved Adapted ACR 30 Response Criteria | Baseline, Day 15, Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and End of Study visit (assesed up to approx. 208 weeks) | Adapted ACR30 response was defined as a ≥30% improvement from baseline in at least 3 of the following 5 core response variables, with no more than one of these variables worsening by \>30%: 1. Physicians global assessment of disease activity (PhGA) on a 0-100 mm VAS (0=very good and 100=very poor). 2. Participant's assessment of disease activity (PtGA) on a 0-100 mm VAS (0=very good and 100=very poor). 3. Health Assessment Questionnaire- disability index (HAQ-DI): 20 questions across 8 domains assessing the functional abilities. The total score was calculated as the average of the scores for each domain, ranging from 0 (no disability) to 3 (very severe disability). 4. Number of active joints (68 joints evaluated for pain/tenderness and 66 for swelling) 5. Index of inflammation: C-reactive Protein (CRP) levels Additionally, participants were required to have no intermittent fever during the preceding week. |
| Secondary | Number of Participants Who Achieved Adapted ACR 50 Response Criteria | Baseline, Day 15, Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and End of Study visit (assesed up to approx. 208 weeks) | Adapted ACR50 response was defined as 50% reduction between baseline in at least 3 of the 5 response variables, with no more than one of these variables worsening by more than 30%: 1. Physicians global assessment of disease activity on a 0-100 mm VAS (0=very good and 100=very poor). 2. Participant's assessment of disease activity (PtGA) on a 0-100 mm VAS (0=very good and 100=very poor). 3. Health Assessment Questionnaire- disability index (HAQ-DI): 20 questions across 8 domains assessing the functional abilities. The total score was calculated as the average of the scores for each domain, ranging from 0 (no disability) to 3 (very severe disability). 4. Number of active joints (68 joints evaluated for pain/tenderness and 66 for swelling) 5. Index of inflammation: C-reactive Protein (CRP) levels Additionally, participants were required to have no intermittent fever during the preceding week. |
| Secondary | Number of Participants Who Achieved Adapted ACR 70 Response Criteria | Baseline, Day 15, Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and End of Study visit (assesed up to approx. 208 weeks) | Adapted ACR70 response was defined as 70% reduction between baseline in at least 3 of the 5 response variables, with no more than one of these variables worsening by more than 30%: 1. Physicians global assessment of disease activity (PhGA) on a 0-100 mm VAS (0=very good and 100=very poor). 2. Participant's assessment of disease activity (PtGA) on a 0-100 mm VAS (0=very good and 100=very poor). 3. Health Assessment Questionnaire- disability index (HAQ-DI): 20 questions across 8 domains assessing the functional abilities. The total score was calculated as the average of the scores for each domain, ranging from 0 (no disability) to 3 (very severe disability). 4. Number of active joints (68 joints evaluated for pain/tenderness and 66 for swelling) 5. Index of inflammation: C-reactive Protein (CRP) levels Additionally, participants were required to have no intermittent fever during the preceding week. |
| Secondary | Number of Participants Who Achieved Adapted ACR 90 Response Criteria | Baseline, Day 15, Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and End of Study visit (assesed up to approx. 208 weeks) | Adapted ACR90 response was defined as 90% reduction between baseline in at least 3 of the 5 response variables, with no more than one of these variables worsening by more than 30%: 1. Physicians global assessment of disease activity (PhGA) on a 0-100 mm VAS (0=very good and 100=very poor). 2. Participant's assessment of disease activity (PtGA) on a 0-100 mm VAS (0=very good and 100=very poor). 3. Health Assessment Questionnaire- disability index (HAQ-DI): 20 questions across 8 domains assessing the functional abilities. The total score was calculated as the average of the scores for each domain, ranging from 0 (no disability) to 3 (very severe disability). 4. Number of active joints (68 joints evaluated for pain/tenderness and 66 for swelling) 5. Index of inflammation: C-reactive Protein (CRP) levels Additionally, participants were required to have no intermittent fever during the preceding week. |
| Secondary | Number of Participants Who Achieved Adapted ACR 100 Response Criteria | Baseline, Day 15, Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and End of Study visit (assesed up to approx. 208 weeks) | Adapted ACR100 response was defined as 100% reduction between baseline in at least 3 of the 5 response variables, with no more than one of these variables worsening by more than 30%: 1. Physicians global assessment of disease activity (PhGA) on a 0-100 mm VAS (0=very good and 100=very poor). 2. Participant's assessment of disease activity (PtGA) on a 0-100 mm VAS (0=very good and 100=very poor). 3. Health Assessment Questionnaire- disability index (HAQ-DI): 20 questions across 8 domains assessing the functional abilities. The total score was calculated as the average of the scores for each domain, ranging from 0 (no disability) to 3 (very severe disability). 4. Number of active joints (68 joints evaluated for pain/tenderness and 66 for swelling) 5. Index of inflammation: C-reactive Protein (CRP) levels Additionally, participants were required to have no intermittent fever during the preceding week. |
| Secondary | Change From Baseline in Systemic Feature Score (SFS) | Baseline, Day 15, Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and End of Study visit (assesed up to approx. 208 weeks) | The SFS evaluated 10 features, each scored as 1 (present) or 0 (absent). The total score ranged from 0 (none present) to 10 (all present). A negative change from baseline indicated clinical improvement. Clinical features: * Fever (\>37.5°C for ≥5 consecutive days) * Rash (salmon-pink during febrile episodes) * Serositis * Lymphadenopathy (\>1.5 cm) * Hepatomegaly/splenomegaly (confirmed by ultrasound or palpation) Laboratory features: At baseline, considered present if: * ESR ≥20 mm/hour * CRP ≥10 mg/L * WBC count ≥12×10⁹/L * Hemoglobin ≤11 g/dL * Platelets ≥400×10⁹/L During treatment and follow-up: * ESR: 0 if \<20 mm/hour or decreased ≥30%; 1 if increased or decreased \<30% * CRP: 0 if \<10 mg/L or decreased ≥30%; 1 if increased or decreased \<30% * WBC count: 0 if \<12×10⁹/L or decreased ≥20%; 1 if increased or decreased \<20% * Hemoglobin: 0 if \>11 g/dL or increased ≥20%; 1 if decreased or increased \<20% * Platelets: 0 if \<400×10⁹/L or decreased ≥20%; 1 if increased or decreased \<20% |
| Secondary | Change From Baseline in the Component of Adapted ACR: Physician's Global Assessment of Disease Activity | aseline, Day 15, Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and End of Study visit (assesed up to approx. 208 weeks) | The physician rated the participant's disease activity on a 0-100 mm VAS, ranging from no disease activity (0 mm) to very severe disease activity (100 mm). A negative change from baseline indicated improvement |
| Secondary | Change From Baseline in the Component of Adapted ACR: Patient's Global Assessment of Disease Activity | Baseline, Day 15, Weeks 4, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, and End of Study visit (assesed up to approx. 208 weeks) | The participant's assessment of disease activity was assessed on the VAS. The VAS scale ranges from 0-100 mm, from no pain/very well (0 mm) to very severe pain/very poor (100 mm). A negative change from baseline indicated improvement |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes0
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/NCT04717635
GET https://conductscience.org/api/trials/v1/NCT04717635/registered