Trial · NCT00770601
Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease
NCT00770601, Phase 3, Terminated, Novartis Pharmaceuticals; results first posted 2021-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease. Trials, record NCT00770601. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00770601
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Canakinumab to Treat Neonatal-Onset Multisystem Inflammatory Disease
- NCT number
- NCT00770601
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- NOMID, CINCA Syndrome
- Interventions
- Canakinumab
- First posted
- 2008-10-10
- Last updated
- 2021-06-10
- Results first posted
- 2021-06-10
- Limitations and caveats
Study was terminated prematurely due to multiple protocol amendments for change in study design; limited number of participants; availability of sufficient clinical data for higher doses of drug and lack of severe NOMID subjects for further evaluation.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete Remission and Relapse After 6 Months of Canakinumab Treatment. | 6 months | The primary endpoint of the study was the percentage of participants experiencing a relapse Central nervous system (CNS) relapse and/or inflammatory relapse) during 6-month open label administration of canakinumab in participant with NOMID/Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA). Complete remission consisted of inflammatory remission and CNS remission. 1 Inflammatory (systemic) remission was defined as follows (all criteria to be fulfilled): -Serum C-reactive protein (CRP) AND serum amyloid A (SAA) ≤ 10 milligrams/litre AND -daily diary score (mean score/week) ≤ 2. 2) CNS remission was defined as follows: Headache score (from the daily diary, mean score/week) \< 0.5 AND, when a lumbar puncture was performed: Normal values of white cell count (WBC) (≤15 cells/mm3) in CSF. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Complete Remission and Relapse After 6 Months of Canakinumab Treatment. | 6 months | The primary analysis was performed on all participants randomized and received at least one dose of study drug. No participant was in stable full remission state as defined by the protocol. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Complete Remission and Relapse After 6 Months of Canakinumab Treatment. | Canakinumab (ACZ885) | 0 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canakinumab (ACZ885) | 7 | |
| Overall Study | COMPLETED | Canakinumab (ACZ885) | 6 | |
| Overall Study | NOT COMPLETED | Canakinumab (ACZ885) | 1 |
Source ClinicalTrials.gov
Adverse events63
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Neutropenia | Blood and lymphatic system disorders | Canakinumab (ACZ885) | 1 | 6 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Canakinumab (ACZ885) | 1 | 6 | |
| other | Ear pain | Ear and labyrinth disorders | Canakinumab (ACZ885) | 2 | 6 | |
| other | Conjunctivitis allergic | Eye disorders | Canakinumab (ACZ885) | 1 | 6 | |
| other | Lacrimation increased | Eye disorders | Canakinumab (ACZ885) | 1 | 6 | |
| other | Vision blurred | Eye disorders | Canakinumab (ACZ885) | 1 | 6 | |
| other | Abdominal pain | Gastrointestinal disorders | Canakinumab (ACZ885) | 1 | 6 | |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Canakinumab (ACZ885) | 1 | 6 | |
| other | Nausea | Gastrointestinal disorders | Canakinumab (ACZ885) | 1 | 6 | |
| other | Condition aggravated | General disorders | Canakinumab (ACZ885) | 1 | 6 |
1 to 10 of 63Source ClinicalTrials.gov
See all 63 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab (ACZ885) | 0 | 6 |
| Total, other adverse events | Canakinumab (ACZ885) | 6 | 6 |
| Total, serious adverse events | Canakinumab (ACZ885) | 1 | 6 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
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/NCT00770601
GET https://conductscience.org/api/trials/v1/NCT00770601/events?page=2