Trial · NCT01242813
Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).
NCT01242813, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2016-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS). Trials, record NCT01242813. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01242813
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of ACZ885 in Patients With Active Recurrent or Chronic TNF-receptor Associated Periodic Syndrome (TRAPS).
- NCT number
- NCT01242813
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 20 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- TNF-receptor Associated Periodic Syndromes (TRAPS)
- Interventions
- ACZ885
- First posted
- 2010-11-17
- Last updated
- 2016-02-04
- Results first posted
- 2016-02-04
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Complete or Almost Complete Response at Day 15 | Day 15 | Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as C reactive protein (CRP) and/or Serum amyloid A protein (SAA) to be less than (\<) 10 milligram per liter (mg/L). Almost complete response was defined as clinical remission and a partial serological remission (equal to or more than \[≥\] 70% reduction of baseline CRP and/or SAA). |
| Secondary | Percentage of Participants With Complete or Almost Complete Response at Day 8 | Day 8 | Complete response was defined as clinical remission and serological remission. Clinical remission was defined as Physician's Global Assessment of TRAPS activity absent or minimal and serological remission was defined as CRP and/or SAA \< 10 mg/L. Almost complete response was defined as clinical remission and a partial serological remission (≥70% reduction of baseline CRP and/or SAA). |
| Secondary | Percentage of Participants With Complete Clinical Remission at Day 8 and 15 | Day 8 and Day 15 | Complete clinical remission was defined as Physician's Global Assessment of TRAPS activity to be absent or minimal (1). TRAPS associated clinical signs and symptoms were assessed by the investigator at every visit on a 5-point scale: 0 = Absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. |
| Secondary | Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15 | Day 8 and Day 15 | The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. |
| Secondary | Time to Physician's Assessed Clinical Remission | Baseline up to Day 15 | Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a Physician's Global Assessment of TRAPS symptoms of scale 1 or less. The physician's Global Assessment was based on a 5-point scale: 0 = None/absent ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. |
| Secondary | Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8 | Day 15 | Participants who had not achieved a complete response at Day 8 were given an additional dose of canakinumab. Complete response was defined as clinical remission (Physician's Global Assessment of TRAPS activity absent or minimal) and serological remission (CRP and/or SAA \< 10 mg/L). Almost complete response was defined as clinical remission and a partial serological remission (≥ 70% reduction of baseline CRP and/or SAA). |
| Secondary | Time to Participant's Assessed Clinical Remission | Baseline up to Day 15 | Time period for complete remission after initial canakinumab treatment as assessed by participants was defined as a participant's Global Assessment of TRAPS symptoms of scale 1 or less. The participant's Global Assessment was based on a 5-point scale: 0 = None/absent (no) ; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. |
| Secondary | Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study | Day 1 up to Day 953 (End of study) | The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. Negative percent change in concentration of inflammatory markers indicated improvement. |
| Secondary | Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain | Day 113 (end of treatment period) up to Day 925 (End of study) | TRAPS signs and symptoms were assessed in 4 key categories: skin disease (skin rash), eye manifestations, extremity pain (musculoskeletal), and abdominal pain. Participants were assessed for TRAPS associated signs and symptoms a 5-point Physician's global assessment scale: None/absent (no); 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. |
| Secondary | Percentage of Participants With Defined Grades in Physician's Global Assessment Score | Day 1 up to Day 953 (End of study) | Participants were assessed based by physician on Physician's Global Assessment measured on a 5-point scale for TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes17
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 or Almost Complete Response at Day 15 | Day 15 | The primary analysis was performed on the Full Analysis Set (FAS), defined as all participants who received at least one dose of study treatment and had at least one post-baseline assessment for primary efficacy. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete or Almost Complete Response at Day 8 | Day 8 | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Complete Clinical Remission at Day 8 and 15 | Day 8 and Day 15 | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15 | Day 8 and Day 15 | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Time to Physician's Assessed Clinical Remission | Baseline up to Day 15 | The analysis was performed on the FAS population. | Days | MEDIAN |
| SECONDARY | Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8 | Day 15 | The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
| SECONDARY | Time to Participant's Assessed Clinical Remission | Baseline up to Day 15 | The analysis was performed on the FAS population. | Days | MEDIAN |
| SECONDARY | Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study | Day 1 up to Day 953 (End of study) | The analysis was performed on the FAS population. | Percent change | MEDIAN |
| SECONDARY | Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain | Day 113 (end of treatment period) up to Day 925 (End of study) | The analysis was performed on the FAS population. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Defined Grades in Physician's Global Assessment Score | Day 1 up to Day 953 (End of study) | The analysis was performed on the FAS population. Here, Number of Participants Analyzed signifies those participants who were evaluable for this outcome measure. | Percentage of participants | NUMBER |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 outcomesResults by group143
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 or Almost Complete Response at Day 15 | Canakinumab | 95 | 95% Confidence Interval 75.1 to 99.9 | Percentage of participants | |
| Percentage of Participants With Complete or Almost Complete Response at Day 8 | Canakinumab | 80 | 95% Confidence Interval 56.3 to 94.3 | Percentage of participants | |
| Percentage of Participants With Complete Clinical Remission at Day 8 and 15 | Canakinumab | Day 8 | 90 | 95% Confidence Interval 68.3 to 98.8 | Percentage of participants |
| Percentage of Participants With Complete Clinical Remission at Day 8 and 15 | Canakinumab | Day 15 | 100 | 95% Confidence Interval 83.2 to 100 | Percentage of participants |
| Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15 | Canakinumab | Day 8 | 35 | 95% Confidence Interval 15.4 to 59.2 | Percentage of participants |
| Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15 | Canakinumab | Day 15 | 60 | 95% Confidence Interval 36.1 to 80.9 | Percentage of participants |
| Time to Physician's Assessed Clinical Remission | Canakinumab | 4 | 95% Confidence Interval 3 to 8 | Days | |
| Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8 | Canakinumab | 100 | 95% Confidence Interval 39.8 to 100 | Percentage of participants | |
| Time to Participant's Assessed Clinical Remission | Canakinumab | 3 | 95% Confidence Interval 1 to 11 | Days | |
| Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to End of Study | Canakinumab | CRP | -92.19 | Full Range -99 to 43.6 | Percent change |
1 to 10 of 143Source ClinicalTrials.gov
See all 143 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 | 20 | |
| Overall Study | COMPLETED | Canakinumab | 18 | |
| Overall Study | NOT COMPLETED | Canakinumab | 2 |
Source ClinicalTrials.gov
Adverse events147
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 | Canakinumab | 2 | 20 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Canakinumab | 2 | 20 | |
| other | Tachycardia | Cardiac disorders | Canakinumab | 1 | 20 | |
| other | Deafness | Ear and labyrinth disorders | Canakinumab | 1 | 20 | |
| other | Ear pain | Ear and labyrinth disorders | Canakinumab | 3 | 20 | |
| other | Chalazion | Eye disorders | Canakinumab | 1 | 20 | |
| other | Conjunctival haemorrhage | Eye disorders | Canakinumab | 1 | 20 | |
| other | Conjunctivitis allergic | Eye disorders | Canakinumab | 1 | 20 | |
| other | Dry eye | Eye disorders | Canakinumab | 1 | 20 | |
| other | Eye pain | Eye disorders | Canakinumab | 1 | 20 |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Canakinumab | ||
| Total, other adverse events | Canakinumab | 20 | 20 |
| Total, serious adverse events | Canakinumab | 7 | 20 |
Source ClinicalTrials.gov
Papers2
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/NCT01242813
GET https://conductscience.org/api/trials/v1/NCT01242813/results?page=2