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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001342-15 |
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This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Canakinumab 150mg | Experimental | Canakinumab 150mg in prefilled syringe subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Canakinumab 150mg in prefilled syringe | Drug | Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Reported Adverse Events | From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Probability of New Gout Flares at End of Study | The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates. | Up to Day 337 |
Not provided
Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Anniston | Alabama | 36207-5710 | United States | ||
| Novartis Investigative Site |
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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A total of 397 participants were randomized in the core study (CACZ885H2361 [NCT01356602]), out of which 232 participants entered the extension study (CACZ885H2361E1 [NCT01431638]).
This study was conducted at 68 centers at Canada, Germany, Lithuania, United States from 25-August-2011 (first participant first visit) to 09-May-2013 (last participant last visit).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Canakinumab, Pre-filled Syringes (PFS) | Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes. |
| FG001 | Canakinumab, Lyophilizate (LYO) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Uncontrolled
Not provided
Not provided
Not provided
Not provided
| Number of Participant With New Flares | The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered. | up to 36 weeks |
| Change From Baseline in Pain Intensity on a 5-point Likert Scale | A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days. | Baseline, upto 14 days post-dose |
| Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. | Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose |
| Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor). | 48 weeks post-dose |
| Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable. | Baseline, 7 days post-dose |
| Number of Participants Responded for Physician's Global Assessment of Response to Treatment | The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor. | 7 days post-dose |
| Gulf Shores |
| Alabama |
| 36547 |
| United States |
| Novartis Investigative Site | Mobile | Alabama | 36608 | United States |
| Novartis Investigative Site | Chandler | Arizona | 85224 | United States |
| Novartis Investigative Site | Scottsdale | Arizona | 85251 | United States |
| Novartis Investigative Site | Buena Park | California | 90620 | United States |
| Novartis Investigative Site | Norwalk | California | 90650 | United States |
| Novartis Investigative Site | Westlake Village | California | 91361 | United States |
| Novartis Investigative Site | Jupiter | Florida | 33458 | United States |
| Novartis Investigative Site | Largo | Florida | 33773 | United States |
| Novartis Investigative Site | South Miami | Florida | 33143 | United States |
| Novartis Investigative Site | Augusta | Georgia | 30904 | United States |
| Novartis Investigative Site | Decatur | Georgia | 30035 | United States |
| Novartis Investigative Site | Topeka | Kansas | 66606 | United States |
| Novartis Investigative Site | Louisville | Kentucky | 40217 | United States |
| Novartis Investigative Site | Owensboro | Kentucky | 42303 | United States |
| Novartis Investigative Site | Metairie | Louisiana | 70006 | United States |
| Novartis Investigative Site | Troy | Michigan | 48085 | United States |
| Novartis Investigative Site | Belzoni | Mississippi | 39038 | United States |
| Novartis Investigative Site | Jackson | Mississippi | 39209 | United States |
| Novartis Investigative Site | Picayune | Mississippi | 39466 | United States |
| Novartis Investigative Site | Missoula | Montana | 59804 | United States |
| Novartis Investigative Site | Lincoln | Nebraska | 68516 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68114 | United States |
| Novartis Investigative Site | Omaha | Nebraska | 68134 | United States |
| Novartis Investigative Site | Mineola | New York | 11501 | United States |
| Novartis Investigative Site | New Hyde Park | New York | 11042 | United States |
| Novartis Investigative Site | Roslyn | New York | 11576 | United States |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | United States |
| Novartis Investigative Site | Cary | North Carolina | 27518 | United States |
| Novartis Investigative Site | Charlotte | North Carolina | 28209 | United States |
| Novartis Investigative Site | Greensboro | North Carolina | 27401 | United States |
| Novartis Investigative Site | Salisbury | North Carolina | 28144 | United States |
| Novartis Investigative Site | Shelby | North Carolina | 28152 | United States |
| Novartis Investigative Site | Wilmington | North Carolina | 28401 | United States |
| Novartis Investigative Site | Fargo | North Dakota | 58103 | United States |
| Novartis Investigative Site | Mogadore | Ohio | 44260 | United States |
| Novartis Investigative Site | Duncansville | Pennsylvania | 16635 | United States |
| Novartis Investigative Site | Charleston | South Carolina | 29412 | United States |
| Novartis Investigative Site | Columbia | South Carolina | 29204 | United States |
| Novartis Investigative Site | Fort Mill | South Carolina | 29707 | United States |
| Novartis Investigative Site | Greer | South Carolina | 29651 | United States |
| Novartis Investigative Site | Varnville | South Carolina | 29944 | United States |
| Novartis Investigative Site | Bristol | Tennessee | 37620 | United States |
| Novartis Investigative Site | Johnson City | Tennessee | 37601 | United States |
| Novartis Investigative Site | Memphis | Tennessee | 38125 | United States |
| Novartis Investigative Site | Bedford | Texas | 76021 | United States |
| Novartis Investigative Site | Dallas | Texas | 75231 | United States |
| Novartis Investigative Site | League City | Texas | 77573 | United States |
| Novartis Investigative Site | Bountiful | Utah | 84010 | United States |
| Novartis Investigative Site | Danville | Virginia | 24541 | United States |
| Novartis Investigative Site | Midlothian | Virginia | 23114 | United States |
| Novartis Investigative Site | Newport News | Virginia | 23606 | United States |
| Novartis Investigative Site | Bellevue | Washington | 98007 | United States |
| Novartis Investigative Site | St. John's | Newfoundland and Labrador | A1A 5E8 | Canada |
| Novartis Investigative Site | St. John's | Newfoundland and Labrador | A1E 2C2 | Canada |
| Novartis Investigative Site | Sainte-Foy | Quebec | G1V 3M7 | Canada |
| Novartis Investigative Site | Regensburg | Bavaria | 93053 | Germany |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Löhne | 32584 | Germany |
| Novartis Investigative Site | Magdeburg | 39110 | Germany |
| Novartis Investigative Site | Weener | 26826 | Germany |
| Novartis Investigative Site | Kaunas | LT | 51349 | Lithuania |
| Novartis Investigative Site | Kaunas | LT | LT-50128 | Lithuania |
| Novartis Investigative Site | Vilnius | LT | 01117 | Lithuania |
| Novartis Investigative Site | KlaipÄ—da | LT-92288 | Lithuania |
| Novartis Investigative Site | Vilnius | 09310 | Lithuania |
| Novartis Investigative Site | Vilnius | LT-08661 | Lithuania |
Participants received 150 mg S.C at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application.
| FG002 | Triamcinolone Acetonide | Participants received 40 mg intramuscular (IM) at randomization and upon new flare. |
| Completed Core Study |
|
| Entered Extension 1 Study |
|
| COMPLETED | Completed Extension Study |
|
| NOT COMPLETED |
|
|
The analysis was performed in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 [NCT01356602]).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Canakinumab, Pre-filled Syringes (PFS) | Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes. |
| BG001 | Canakinumab, Lyophilizate (LYO) | Participants received 150 mg S.C at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. |
| BG002 | Triamcinolone Acetonide | Participants received 40 mg intramuscular (IM) at randomization and upon new flare. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | 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 | Number of Participants Who Reported Adverse Events | Safety Set consisted of all participants that received study drug in the core study (CACZ885H2361 [NCT01356602]) and had at least one post-baseline safety assessment. The patients with more than one treatment are counted in the Safety Set under those treatment groups as the actual treatments they received. Thus, the number of subjects in the treatment arms are more than the number of randomized subjects. | Posted | Count of Participants | Participants | From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks) |
|
|
| |||||||||||||||||||||||||||||||||
| Secondary | Probability of New Gout Flares at End of Study | The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates. | Full Analysis Set (FAS) consisted of all participants randomized in the core study (CACZ885H2361 [NCT01356602]) that had taken at least one dose of study drug. | Posted | Number | 95% Confidence Interval | Probability | Up to Day 337 |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participant With New Flares | The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered. | FAS consisted of all participants randomized in the core study (CACZ885H2361 [NCT01356602]) that had taken at least one dose of study drug. | Posted | Count of Participants | Participants | up to 36 weeks |
| ||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain Intensity on a 5-point Likert Scale | A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days. | Modified Analysis Set (MAS) consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, upto 14 days post-dose |
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time | Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left. | MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose |
| |||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment | Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor). | MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 48 weeks post-dose |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint | Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable. | MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure and at specific category. | Posted | Count of Participants | Participants | Baseline, 7 days post-dose |
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants Responded for Physician's Global Assessment of Response to Treatment | The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor. | MAS consisted of all FAS participants. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Posted | Count of Participants | Participants | 7 days post-dose |
|
From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)
Adverse events were evaluated in the Randomized Set population defined as all participants who were randomized at least one dose of study drug in the core study (CACZ885H2361 [NCT01356602]).
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, Pre-filled Syringes (PFS) | Participants received 150 mg subcutaneously (S.C) at randomization and upon new flare. The doses were provided as pre-filled syringes. | 1 | 133 | 12 | 133 | 10 | 133 |
| EG001 | Canakinumab, Lyophilizate (LYO) | Participants received 150 mg S.C at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. | 0 | 132 | 7 | 132 | 13 | 132 |
| EG002 | Triamcinolone Acetonide | Participants received 40 mg intramuscular (IM) at randomization and upon new flare. | 0 | 132 | 7 | 132 | 10 | 132 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Drug ineffective | General disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory tract infection viral | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Muscle rupture | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA (16.0) | Systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (16.0) | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Calculus ureteric | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Obstructive uropathy | Renal and urinary disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Aortitis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA (16.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (16.0) | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| ID | Term |
|---|---|
| D006073 | Gout |
| D001168 | Arthritis |
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C541220 | canakinumab |
Not provided
Not provided
Not provided
| >= 65-74 years |
|
| >= 75 years |
|
| Male |
|
| Black |
|
| Asian |
|
| Native american |
|
| Pacific islander |
|
| Other |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
| OG002 | Triamcinolone Acetonide | Participants received 40 mg intramuscular (IM) at randomization and upon new flare. |
|
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
Participants received 40 mg intramuscular (IM) at randomization and upon new flare. |
|
|
| Units | Counts |
|---|
| Participants |
|
|