Trial · NCT02059291
Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
NCT02059291, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2017-03-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers. Trials, record NCT02059291. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02059291
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers
- NCT number
- NCT02059291
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 203 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hereditary Periodic Fevers
- Interventions
- Canakinumab, Placebo
- First posted
- 2014-02-11
- Last updated
- 2018-05-17
- Results first posted
- 2017-03-17
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) | 16 weeks | Resolution of the initial disease flare is defined as: Physician's Global Assessment of Disease activity (PGA) \<2 and C-reactive protein (CRP) within normal range (\<= 10 mg/L) or reduction by at least 70% from baseline. The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms. |
| Secondary | Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2 | 16 weeks | The PGA was evaluated by the investigator based on a 5-point scale: 0 = None (no) disease associated with clinical signs and symptoms; 1 = minimal disease associated signs and symptoms; 2 = mild disease associated signs and symptoms; 3 = moderate disease associated signs and symptoms; and 5 = severe disease associated signs and symptoms. |
| Secondary | Percentage of Participants With the Serologic Remission | 16 weeks | Serologic remission was defined as C-reactive protein \<= 10 mg/L. |
| Secondary | Percentage of Participants With Normalized Serum Amyloid A (SAA) Level | 16 weeks | Normalized SAA was defined as SAA \<= 10 mg/L. |
| Secondary | Percentage of Participants of Canakinumab Responders From Epoch 2 Who Maintained a Clinically Meaningful Response (Absence of New Flares) (40 Weeks) | 40 weeks | A responder was defined as a participant who had no flare between week 16 and week 40. |
Source ClinicalTrials.gov
Outcomes5
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 Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) | 16 weeks | The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2 | 16 weeks | The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With the Serologic Remission | 16 weeks | The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Normalized Serum Amyloid A (SAA) Level | 16 weeks | The Full Analysis Set (FAS), which consisted of all randomized participants in the randomized treatment epoch who received at least one dose of study drug in Epoch 2, was analyzed. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants of Canakinumab Responders From Epoch 2 Who Maintained a Clinically Meaningful Response (Absence of New Flares) (40 Weeks) | 40 weeks | The re-randomized set was analyzed. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group30
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 Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) | Epoch 2: crFMF: 150 mg | 61.29 | Percentage of participants | ||
| Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) | Epoch 2: crCMF: Placebo | 6.25 | Percentage of participants | ||
| Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) | Epoch 2: HIDS/MKD: 150 mg | 35.14 | Percentage of participants | ||
| Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) | Epoch 2: HIDS/MKD: Placebo | 5.71 | Percentage of participants | ||
| Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) | Epoch 2: TRAPS: 150 mg | 45.45 | Percentage of participants | ||
| Percentage of Participants With Resolution of Initial Flare and Absence of New Flares up to the End of the Randomized Treatment Epoch (16 Weeks) | Epoch 2: TRAPS: Placebo | 8.33 | Percentage of participants | ||
| Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2 | Epoch 2: crFMF: 150 mg | 64.52 | Percentage of participants | ||
| Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2 | Epoch 2: crCMF: Placebo | 9.38 | Percentage of participants | ||
| Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2 | Epoch 2: HIDS/MKD: 150 mg | 45.95 | Percentage of participants | ||
| Percentage of Participants Who Achieve Physician's Global Assessment (PGA) < 2 | Epoch 2: HIDS/MKD: Placebo | 5.71 | Percentage of participants |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow225
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Epoch 2 | STARTED | Epoch 2: crFMF: 150 mg | 31 | |
| Epoch 2 | STARTED | Epoch 2: crCMF: Placebo | 32 | |
| Epoch 2 | STARTED | Epoch 2: HIDS/MKD: 150 mg | 37 | |
| Epoch 2 | STARTED | Epoch 2: HIDS/MKD: Placebo | 35 | |
| Epoch 2 | STARTED | Epoch 2: TRAPS: 150 mg | 22 | |
| Epoch 2 | STARTED | Epoch 2: TRAPS: Placebo | 24 | |
| Epoch 2 | STARTED | Epoch 2: Non-randomized Open Label Treatment - crFMF | 2 | |
| Epoch 2 | STARTED | Epoch 2: Non-randomized Open Label HIDS/MKD | 2 | |
| Epoch 2 | STARTED | Epoch 2 (Epoch 3) - Non-randomized Open Label TRAPS | 18 | |
| Epoch 2 | STARTED | Epoch 3: crFMF Re-randomized From Epoch 2 - 150 mg | 0 |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 participant flowAdverse events3,980
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 | Anaemia | Blood and lymphatic system disorders | Non-randomized Open Label crFMF, HIDS/MKD Patients | 0 | 4 | |
| other | Anaemia | Blood and lymphatic system disorders | Non-randomized Open Label TRAPS Patients | 1 | 18 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomized ACZ and Placebo TRAPS Patients - Placebo Events | 0 | 46 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomized ACZ and Placebo TRAPS Pts - No Medication Events | 0 | 46 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomized ACZ and Placebo TRAPS Patients - ACZ Events | 0 | 46 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events | 1 | 72 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events | 0 | 72 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events | 4 | 72 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomized ACZ and Placebo crFMF Patients - Placebo Events | 1 | 63 | |
| other | Anaemia | Blood and lymphatic system disorders | Randomized ACZ and Placebo crFMF Pts - No Medication Events | 0 | 63 |
1 to 10 of 3,980Source ClinicalTrials.gov
See all 3,980 adverse eventsAdverse event totals60
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-randomized Open Label crFMF, HIDS/MKD Patients | 0 | 4 |
| Total, all-cause mortality | Non-randomized Open Label TRAPS Patients | 0 | 18 |
| Total, all-cause mortality | Randomized ACZ and Placebo TRAPS Patients - Placebo Events | 0 | 46 |
| Total, all-cause mortality | Randomized ACZ and Placebo TRAPS Pts - No Medication Events | 0 | 46 |
| Total, all-cause mortality | Randomized ACZ and Placebo TRAPS Patients - ACZ Events | 0 | 46 |
| Total, all-cause mortality | Randomized ACZ and Placebo HIDS/MKD Pts - Placebo Events | 0 | 72 |
| Total, all-cause mortality | Randomized ACZ and Placebo HIDS/MKD Pts - No Medication Events | 0 | 72 |
| Total, all-cause mortality | Randomized ACZ and Placebo HIDS/MKD Patients - ACZ Events | 0 | 72 |
| Total, all-cause mortality | Randomized ACZ and Placebo crFMF Patients - Placebo Events | 0 | 63 |
| Total, all-cause mortality | Randomized ACZ and Placebo crFMF Pts - No Medication Events | 0 | 63 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse event totalsPapers3
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/NCT02059291
GET https://conductscience.org/api/trials/v1/NCT02059291/results?page=2