Trial · NCT00465985
Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
NCT00465985, Phase 3, Completed, Novartis; results first posted 2011-02-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome. Trials, record NCT00465985. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00465985
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety, and Tolerability of ACZ885 in Patients With Muckle-Wells Syndrome
- NCT number
- NCT00465985
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 35 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Muckle Wells Syndrome
- Interventions
- ACZ885, Placebo
- First posted
- 2007-04-27
- Last updated
- 2017-08-28
- Results first posted
- 2011-02-11
- Limitations and caveats
- The outcomes for this study were reported in separate tables for each period. The SAE and AEs were reported in all in one table.
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part) | 32 weeks after study start | Determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Data expressed as a percent of participants who had experienced a flare by the end of Part II. |
| Primary | Number of Participants Who Experienced a Disease Flare in Part II | 32 weeks after study start | Disease flare is determined by the Physician's global assessment of autoinflammatory disease activity, assessment of skin disease and inflammation markers. Disease Flare = the C-reactive protein and/or serum amyloid A (SAA) \> 30 mg/L and either a PGA \> minimal, or PGA equal to minimal and \> minimal SD. |
| Secondary | Number of Participants With Treatment Response in Part I (After 8 Weeks) | 8 weeks after study start | Treatment response was based on Physician's global assessment(PGA) of autoinflammatory disease activity, assessment of skin disease(SD) and serum values of C-reactive protein(CRP) and/or serum amyloid A(SAA). Complete Response (CR):PGA and SD ≤ minimal and normal CRP and/or SAA. Partial Response (PR): a reduction of CRP and/or SAA from baseline (BL) by \>30% but not reaching normal values and PGA improvement from BL by at least one category. Disease flare: a CRP and/or SAA \> 30 mg/L and either PGA \> minimal or PGA = minimal and SD \> minimal. Non-responders = no PR by Day 8 or no CR by Day 15. |
| Secondary | Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part) | 32 weeks after study start | A 5-point scale was used for the Physician's global assessment on autoinflammatory disease activity (absent, minimal, mild, moderate and severe) and for the assessment of the following items: * skin disease (urticarial skin rash) * arthralgia * myalgia * headache/migraine * conjunctivitis * fatigue/malaise * other symptoms related to autoinflammatory syndrome * other symptoms not related to autoinflammatory syndrome |
| Secondary | Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8. | Week 8 and Week 32 | |
| Secondary | Pharmacokinetics (CLD (L/d)) | 48 weeks after study start | Assessed serum clearance of ACZ885. |
| Secondary | Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I. | until Week 8 | |
| Secondary | Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II. | 32 weeks after study start | |
| Secondary | Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III. | 48 weeks after study start |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part) | 32 weeks after study start | percent of participants | NUMBER | |
| SECONDARY | Number of Participants With Treatment Response in Part I (After 8 Weeks) | 8 weeks after study start | Participants | NUMBER | |
| SECONDARY | Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part) | 32 weeks after study start | Participants | NUMBER | |
| SECONDARY | Change in Inflammation Markers at the End of Part II (C-reactive Protein and/or Serum Amyloid A) (After 24 Weeks of the Double-blind Part) From Week 8. | Week 8 and Week 32 | Intention to treat (ITT)population and LOCF. | mg/L | MEAN |
| SECONDARY | Pharmacokinetics (CLD (L/d)) | 48 weeks after study start | Patients in Part I and Part II who received at least one dose of ACZ885. | L/day | MEAN |
| PRIMARY | Number of Participants Who Experienced a Disease Flare in Part II | 32 weeks after study start | Participants | NUMBER | |
| SECONDARY | Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part I. | until Week 8 | Intention to treat (ITT) population. | pg/mL | MEAN |
| SECONDARY | Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part II. | 32 weeks after study start | Intention to treat (ITT) population. | pg/mL | MEAN |
| SECONDARY | Pharmacodynamics Measured by Interleukin-1β (IL-1β) Concentrations at End of Part III. | 48 weeks after study start | Intention to treat (ITT) population. | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group27
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part) | ACZ885 | 0 | percent of participants | ||
| Percent of Participants With Disease Flare in Part II (After 24 Weeks of the Double-blind Part) | Placebo | 81.3 | percent of participants | ||
| Number of Participants With Treatment Response in Part I (After 8 Weeks) | ACZ885 | Complete response | 31 | 25.200 | Participants |
| Number of Participants With Treatment Response in Part I (After 8 Weeks) | ACZ885 | Partial response | 2 | Participants | |
| Number of Participants With Treatment Response in Part I (After 8 Weeks) | ACZ885 | Disease flare | 1 | Participants | |
| Number of Participants With Treatment Response in Part I (After 8 Weeks) | ACZ885 | Non-responder (protocol violation) | 1 | Participants | |
| Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part) | ACZ885 | Absent | 8 | Participants | |
| Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part) | Placebo | Absent | 0 | Participants | |
| Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part) | ACZ885 | Minimal | 7 | Participants | |
| Investigator's Clinical Assessment of Autoinflammatory Disease Activity & Participant's Assessment of Symptoms at End of Part II (After 24 Weeks of the Double-blind Part) | Placebo | Minimal | 4 | Participants |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part I - Open-label Treatment Period | STARTED | ACZ885 | 35 | |
| Part I - Open-label Treatment Period | STARTED | Placebo | 0 | |
| Part I - Open-label Treatment Period | COMPLETED | ACZ885 | 31 | |
| Part I - Open-label Treatment Period | COMPLETED | Placebo | 0 | |
| Part I - Open-label Treatment Period | NOT COMPLETED | ACZ885 | 4 | |
| Part I - Open-label Treatment Period | NOT COMPLETED | Placebo | 0 | |
| Part II - 1:1 ACZ885:Placebo | STARTED | ACZ885 | 15 | |
| Part II - 1:1 ACZ885:Placebo | STARTED | Placebo | 16 | |
| Part II - 1:1 ACZ885:Placebo | COMPLETED | ACZ885 | 15 | |
| Part II - 1:1 ACZ885:Placebo | COMPLETED | Placebo | 4 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events465
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 | Lymphocytosis | Blood and lymphatic system disorders | Part I ACZ885 | 0 | 35 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Part II ACZ885 | 0 | 15 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Part II Placebo | 1 | 16 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Part III ACZ885 | 0 | 31 | |
| other | Lymphocytosis | Blood and lymphatic system disorders | Entire Study ACZ885 | 1 | 35 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part I ACZ885 | 0 | 35 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part II ACZ885 | 0 | 15 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part II Placebo | 1 | 16 | |
| other | Neutropenia | Blood and lymphatic system disorders | Part III ACZ885 | 0 | 31 | |
| other | Neutropenia | Blood and lymphatic system disorders | Entire Study ACZ885 | 1 | 35 |
1 to 10 of 465Source ClinicalTrials.gov
See all 465 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part I ACZ885 | ||
| Total, all-cause mortality | Part II ACZ885 | ||
| Total, all-cause mortality | Part II Placebo | ||
| Total, all-cause mortality | Part III ACZ885 | ||
| Total, all-cause mortality | Entire Study ACZ885 | ||
| Total, other adverse events | Part I ACZ885 | 27 | 35 |
| Total, other adverse events | Part II ACZ885 | 15 | 15 |
| Total, other adverse events | Part II Placebo | 14 | 16 |
| Total, other adverse events | Part III ACZ885 | 24 | 31 |
| Total, other adverse events | Entire Study ACZ885 | 35 | 35 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers2
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| ACZ885 vs Placebo: Number of Participants Who Experienced a Disease Flare in Part II |
Source Trial comparisons
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/NCT00465985
GET https://conductscience.org/api/trials/v1/NCT00465985/results?page=2