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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020061-24 |
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This trial will assess the safety and efficacy of ACZ885 in patients with active recurrent or chronic TNF-receptor associated periodic syndrome (TRAPS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab | Experimental | This was an open-label, single treatment arm, multicenter study of monthly canakinumab 150 mg (2 mg/kg for patient ≤ 40 kg) subcutaneous injections in patients with active recurrent or chronic TRAPS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACZ885 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete or Almost Complete Response at 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). | Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Complete or Almost Complete Response at 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). |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL).
Women of child-bearing potential, defined as pre-menarche females aged 8 years and above or all women physiologically capable of becoming pregnant, UNLESS they are
History of being immunocompromised, including a positive HIV at screening (ELISA and Western blot) test result.
Positive QuantiFERON (QFT-TB G In-Tube) test or positive Purified Protein Derivative (PPD) test (>or= 5 mm induration) at screening or within 2 month prior to the screening visit, according to the national guidelines. Patients with a positive PPD test (>or= 5 mm induration) at screening may be enrolled only if they have either a negative chest x-ray or a negative QuantiFERON test.
Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose.
History of significant other medical conditions, which in the Investigator's opinion would exclude the patient from participating in this trial.
History of recurrent and/or evidence of active bacterial, fungal, or viral infection(s).
Use of prohibited therapies, any other investigational biologics within 8 weeks prior to the Baseline visit, any other investigational drugs, other than investigational biologic treatment, within 30 days (or 3 months for investigational monoclonal antibodies) or 5 half-lives prior to the Baseline visit, whichever is longer
History of known hypersensitivity to canakinumab.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Other protocol defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Galway | Ireland | Ireland | |||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27474763 | Derived | Torene R, Nirmala N, Obici L, Cattalini M, Tormey V, Caorsi R, Starck-Schwertz S, Letzkus M, Hartmann N, Abrams K, Lachmann H, Gattorno M. Canakinumab reverses overexpression of inflammatory response genes in tumour necrosis factor receptor-associated periodic syndrome. Ann Rheum Dis. 2017 Jan;76(1):303-309. doi: 10.1136/annrheumdis-2016-209335. Epub 2016 Jul 29. | |
| 27269295 |
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A total of 29 participants were screened, out of which 20 were enrolled and exposed to study medication. Nine participants were considered as screening failures due to unacceptable laboratory value or test procedure results.
The study was conducted at 6 centers in 3 countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Canakinumab | Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Day 8 |
| Percentage of Participants With Complete Clinical Remission at Day 8 and 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. | Day 8 and Day 15 |
| Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15 | The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. | Day 8 and Day 15 |
| Time to Physician's Assessed Clinical Remission | 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. | Baseline up to Day 15 |
| Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8 | 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). | Day 15 |
| Time to Participant's Assessed Clinical Remission | 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. | Baseline up to Day 15 |
| Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to 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. | Day 1 up to Day 953 (End of study) |
| Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain | 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. | Day 113 (end of treatment period) up to Day 925 (End of study) |
| Percentage of Participants With Defined Grades in Physician's Global Assessment Score | 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. | Day 1 up to Day 953 (End of study) |
| Percentage of Participants With Defined Grades in Participant's Global Assessment Score | Participants assessed the disease condition based on a 5-point participant's global assessment scale based on TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. | Day 1 up to Day 253 (End of follow-up period) |
| Percentage of Relapsed Participants | Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15. | Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953 |
| Time to Relapse After Last Dose of Canakinumab | Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15. | Day 85 to Day 253 (End of treatment period to Follow-up period) |
| Percentage of Participants Who Relapsed and Received Rescue Medication | Participants who relapsed after the last dose of canakinumab and received either corticosteroid treatment or NSAID or both corticosteroid treatment and NSAID as rescue medication. | Day 85 to Day 953 (End of treatment period to End of study) |
| Serum Concentration of Canakinumab | Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics of the drug. | Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953 |
| Serum Concentration of Total Interleukin-1β Antibody (IL-1β) | Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of competitive Enzyme-linked immunosorbent assay (ELISA) with limit of detection at 0.25 picogram/milliliter (pg/mL). | Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953 |
| Number of Participants With Anti-canakinumab Antibodies at Any Visit | Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system. | Day 1 up to Day 953 (End of study) |
| Sciacca |
| AG |
| 92019 |
| Italy |
| Novartis Investigative Site | Brescia | BS | 25123 | Italy |
| Novartis Investigative Site | Genova | GE | 16147 | Italy |
| Novartis Investigative Site | Pavia | PV | 27100 | Italy |
| Novartis Investigative Site | London | NW3 2QG | United Kingdom |
| Gattorno M, Obici L, Cattalini M, Tormey V, Abrams K, Davis N, Speziale A, Bhansali SG, Martini A, Lachmann HJ. Canakinumab treatment for patients with active recurrent or chronic TNF receptor-associated periodic syndrome (TRAPS): an open-label, phase II study. Ann Rheum Dis. 2017 Jan;76(1):173-178. doi: 10.1136/annrheumdis-2015-209031. Epub 2016 Jun 7. |
| COMPLETED |
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| NOT COMPLETED |
|
|
The analysis was performed on Safety Set (SAF) defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Canakinumab | Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Complete or Almost Complete Response at 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). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 15 |
|
|
| |||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete or Almost Complete Response at 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). | The analysis was performed on the FAS population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 8 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete Clinical Remission at Day 8 and 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. | The analysis was performed on the FAS population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 8 and Day 15 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participant With Target Levels of C-reactive Protein (CRP) and Serum Amyloid A Protein (SAA) at Day 8 and 15 | The CRP and SAA were used as inflammatory markers. The target level concentration was ≤ 10 mg/L. | The analysis was performed on the FAS population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 8 and Day 15 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Physician's Assessed Clinical Remission | 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. | The analysis was performed on the FAS population. | Posted | Median | 95% Confidence Interval | Days | Baseline up to Day 15 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Complete or Almost Complete Response at Day 15 After Receiving Additional Dose at Day 8 | 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). | The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 15 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Participant's Assessed Clinical Remission | 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. | The analysis was performed on the FAS population. | Posted | Median | 95% Confidence Interval | Days | Baseline up to Day 15 |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage Change From Baseline in C-reactive Protein (CRP) and Serum Amyloid A (SAA) Concentration to 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. | The analysis was performed on the FAS population. | Posted | Median | Full Range | Percent change | Day 1 up to Day 953 (End of study) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Defined Grades for Skin Rash, Eye Manifestations, Extremity Pain and Abdominal Pain | 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. | The analysis was performed on the FAS population. | Posted | Number | Percentage of participants | Day 113 (end of treatment period) up to Day 925 (End of study) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Defined Grades in Physician's Global Assessment Score | 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. | The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Day 1 up to Day 953 (End of study) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Defined Grades in Participant's Global Assessment Score | Participants assessed the disease condition based on a 5-point participant's global assessment scale based on TRAPS associated signs and symptoms as: 0 = None/absent; 1 = Minimal; 2 = Mild; 3 = Moderate; 4 = Severe. | The analysis was performed on the FAS population. Here, "Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | Day 1 up to Day 253 (End of follow-up period) |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Relapsed Participants | Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15. | The analysis was performed on the FAS population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449,477,505, 533, 561, 589, 617, 645, 673,701, 729,757, 785, 813, 841,869, 897, 925 and 953 |
|
| ||||||||||||||||||||||||||
| Secondary | Time to Relapse After Last Dose of Canakinumab | Relapse was defined as a Physician's Global Assessment score of 2 (and an increase of at least 1 point compared to Day 15) and CRP and/or SAA ≥ 30 mg/L representing a 30% increase from Day 15. | The analysis was performed on the FAS population. | Posted | Median | 95% Confidence Interval | Days | Day 85 to Day 253 (End of treatment period to Follow-up period) |
|
| ||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Relapsed and Received Rescue Medication | Participants who relapsed after the last dose of canakinumab and received either corticosteroid treatment or NSAID or both corticosteroid treatment and NSAID as rescue medication. | The analysis was performed on the FAS population. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 85 to Day 953 (End of treatment period to End of study) |
|
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| Secondary | Serum Concentration of Canakinumab | Canakinumab concentrations in serum were assessed for evaluating pharmacokinetics of the drug. | The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | microgram(s)/milliliter | Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953 |
|
| ||||||||||||||||||||||||||
| Secondary | Serum Concentration of Total Interleukin-1β Antibody (IL-1β) | Pharmacodynamics of canakinumab was assessed by total IL-1β (sum of free and bound canakinumab) concentration, determined in serum by means of competitive Enzyme-linked immunosorbent assay (ELISA) with limit of detection at 0.25 picogram/milliliter (pg/mL). | The analysis was performed on the FAS population. The 'n' signifies those participants evaluable for this measure at specified time points for each group, respectively. | Posted | Mean | Standard Deviation | pg/mL | Day 3, 8, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 365, 393, 421, 449, 533, 561, 589, 617, 645, 673, 729, 785, 841, 897, 925 and 953 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Anti-canakinumab Antibodies at Any Visit | Immunogenicity assessment included determination of anti-canakinumab (ACZ885) antibodies in serum samples using BIAcore system. | The analysis was performed on the FAS population. | Posted | Number | Number of participants | Day 1 up to Day 953 (End of study) |
|
|
Day 1 up to Day 953 (End of study)
The analysis was performed in the SAF population, defined as all participants who received at least one application of study treatment and had least one post-baseline safety assessment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Canakinumab | Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare. | 7 | 20 | 20 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Deafness | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
| |
| Chalazion | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye pruritus | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eye swelling | Eye disorders | MedDRA | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA | Systematic Assessment |
| |
| Periorbital oedema | Eye disorders | MedDRA | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Condition aggravated | General disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Enterobiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Haemorrhoid infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Onychomycosis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tinea infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Urinary tract infection viral | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Skeletal injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Sunburn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood iron decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Blood triglycerides increased | Investigations | MedDRA | Systematic Assessment |
| |
| Occult blood positive | Investigations | MedDRA | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Sinus headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Polyuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Strangury | Renal and urinary disorders | MedDRA | Systematic Assessment |
| |
| Breast cyst | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Breast mass | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dermal cyst | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Ingrown hair | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Skin discolouration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
| |
| Nasal septal operation | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Skin neoplasm excision | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Tooth extraction | Surgical and medical procedures | MedDRA | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| C536657 | Periodic fever, familial, autosomal dominant |
| D005334 | Fever |
| D005076 | Exanthema |
| D015746 | Abdominal Pain |
| D054517 | Orbital Cellulitis |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012817 | Signs and Symptoms, Digestive |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D002481 | Cellulitis |
| D003240 | Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C541220 | canakinumab |
Not provided
Not provided
Not provided
| United Kingdom |
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