Trial · NCT00685373
Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
NCT00685373, Phase 3, Completed, Novartis; results first posted 2011-05-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease. Trials, record NCT00685373. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00685373
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Efficacy and Safety of ACZ885 in Patients With the Following Cryopyrin-associated Periodic Syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome, or Neonatal Onset Multisystem Inflammatory Disease
- NCT number
- NCT00685373
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 166 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Cryopyrin-Associated Periodic Syndromes, Familial Cold Autoinflammatory Syndrome, Muckle Wells Syndrome, Neonatal Onset Multisystem Inflammatory Disease
- Interventions
- Canakinumab (ACZ885)
- First posted
- 2008-05-28
- Last updated
- 2016-11-04
- Results first posted
- 2011-05-27
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | 2 years depending on when the participant enters the study | The number of participants with Adverse Events and Infections \& Infestations are regardless of study drug relationship by primary system organ class preferred term equal and/or greater than 2% in any group. The number of participants with mild injection site reactions= mild reactions observed on at least one occasion but no moderate or severe reactions. The number of participants with moderate injection site reactions= moderate reactions observed on at least one occasion but no severe reactions. |
| Secondary | The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers. | Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years | Disease relapse following complete response is defined as inflammation markers: C-Reactive Protein (CRP) and/or Serum Amyloid A (SAA) result \> 30 mg/L AND Physician's Global Assessment of Autoinflammatory Disease Activity \> minimal or Physician's Global Assessment \>= minimal AND Skin Disease Assessment \> minimal. Physician's Global Assessment of Autoinflammatory Disease Activity and Skin Disease Assessment (urticarial skin rash) are completed by the investigator using a 5 point rating scale: absent, minimal, mild, moderate and severe. |
| Secondary | Immunogenicity of Canakinumab (ACZ885) | Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years | The number of participants who tested positive for anti-ACZ885 antibodies using the Biacore Assay at the end of the study. |
| Secondary | Pharmacokinetics | Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years | Mean Clearance from serum in Liter per Day (CLD) in adult participants \>=18, pediatric participants \<18 with body weight \>40 kg and pediatric participants \<18 with body weight \<=40 kg. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | 2 years depending on when the participant enters the study | Safety Population defined as all participants who received at least one dose of study drug. | participants | NUMBER |
| SECONDARY | The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers. | Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years | Safety Population defined as all participants who had at least one dose of study drug and were included in the Relapse Assessment. | Percentage of participants | NUMBER |
| SECONDARY | Immunogenicity of Canakinumab (ACZ885) | Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years | Safety Population defined as all participants who received at least one dose of study drug and were tested for anti-ACZ885 antibodies at the end of the study. | participants | NUMBER |
| SECONDARY | Pharmacokinetics | Every 8 weeks during the course of the trial for at least 6 months with a maximum duration of 2 years | Safety population defined as all participants who received at least 1 dose of study drug. 3 participants were excluded because dosing information was not available at the time of analysis. | L/day | MEAN |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | Canakinumab (ACZ885) | Adverse Event | 150 | participants | |
| The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | Canakinumab (ACZ885) | Death | 0 | participants | |
| The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | Canakinumab (ACZ885) | Serious Adverse Event | 18 | participants | |
| The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | Canakinumab (ACZ885) | Discontinuation of study drug due to an AE | 4 | participants | |
| The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | Canakinumab (ACZ885) | Infections and Infestations | 109 | participants | |
| The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | Canakinumab (ACZ885) | Any Injection Site Reactions | 13 | participants | |
| The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | Canakinumab (ACZ885) | Mild Injection Site Reactions | 11 | participants | |
| The Number of Participants With Adverse Events (AEs), Death, Serious Adverse Events (SAEs), Discontinuation of Study Drug Due to an AE, Infections and Infestations and Injection Site Reactions | Canakinumab (ACZ885) | Moderate Injection Site Reactions | 2 | participants | |
| The Percentage of Participants Without Disease Relapse as Determined by the Physician's Global Assessment of Autoinflammatory Disease Activity, Assessment of Skin Disease and Inflammation Markers. | Canakinumab (ACZ885) | 90.1 | Percentage of participants | ||
| Immunogenicity of Canakinumab (ACZ885) | Canakinumab (ACZ885) | 0 | participants |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Canakinumab (ACZ885) | 166 | |
| Overall Study | COMPLETED | Canakinumab (ACZ885) | 151 | |
| Overall Study | NOT COMPLETED | Canakinumab (ACZ885) | 15 |
Source ClinicalTrials.gov
Adverse events39
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 | Abdominal pain | Gastrointestinal disorders | Canakinumab (ACZ885) | 13 | 166 | |
| other | Diarrhoea | Gastrointestinal disorders | Canakinumab (ACZ885) | 18 | 166 | |
| other | Nausea | Gastrointestinal disorders | Canakinumab (ACZ885) | 11 | 166 | |
| other | Vomiting | Gastrointestinal disorders | Canakinumab (ACZ885) | 16 | 166 | |
| other | Pyrexia | General disorders | Canakinumab (ACZ885) | 18 | 166 | |
| other | Bronchitis | Infections and infestations | Canakinumab (ACZ885) | 18 | 166 | |
| other | Gastroenteritis | Infections and infestations | Canakinumab (ACZ885) | 12 | 166 | |
| other | Nasopharyngitis | Infections and infestations | Canakinumab (ACZ885) | 48 | 166 | |
| other | Rhinitis | Infections and infestations | Canakinumab (ACZ885) | 27 | 166 | |
| other | Upper respiratory tract infection | Infections and infestations | Canakinumab (ACZ885) | 17 | 166 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab (ACZ885) | ||
| Total, other adverse events | Canakinumab (ACZ885) | 124 | 166 |
| Total, serious adverse events | Canakinumab (ACZ885) | 18 | 166 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21859692 | DERIVED |
Source PubMed
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/NCT00685373
GET https://conductscience.org/api/trials/v1/NCT00685373/events?page=2