TriangleNCT01356602 · CITED IN SOURCE DOCUMENTS
Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2014-01-29
This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups
Patient's Assessment of Pain Intensity on a 0-100mm VAS
Patient's Assessment of Pain Intensity on a 5-point Likert Scale
Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
Time to the First New Gouty Arthritis Flare
Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
Time to Resolution of Gouty Arthritis Flare as Reported by Patient
Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
Physician's Assessment of Tenderness
Physician's Assessment of Swelling
Physician's Assessment of Erythema
Physician's Assessment of Range of Motion of the Most Affected Joint
Proportion of Patients With Rescue Medication Intake
Time to First Rescue Medication Intake
Amount of Rescue Medication Taken (mg)
C-reactive Protein Level
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion criteria: * 3 or more gout flares within last year * Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine * Body mass index of less than or equal to 45 kg/m2 Exclusion criteria: * Use of the following therapies (within varying protocol defined timeframes): corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs (such as aspirin), colchicine. * Hemodialysis * Live vaccine within 3 months before first dose * Donation or loss of 400 mL or more within 3 months before first dose * Gout brought on by other factors such as chemotherapy, lead, transplant, etc. * Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis * Any conditions or significant medical problems that puts the patient at an unacceptable immunological risk to receive this type of therapy such as HIV, Hepatitis, Tuberculosis and other infections/conditions * Significant cardiovascular conditions such as uncontrolled hypertension * Significant medical diseases such as uncontrolled diabetes, thyroid disease * History of malignancy of any organ system within the past 5 years * Women who are pregnant or nursing * Other protocol-defined inclusion/exclusion criteria may apply
- healthy Volunteers
- false
- maximum Age
- 85 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
- intervention Names
- Drug: Canakinumab pre-filled syringe
- Drug: Placebo
- label
- Canakinumab, pre-filled syringes (PFS)
- type
- EXPERIMENTAL
- description
- The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
- intervention Names
- Drug: Canakinumab lyophilized powder
- Drug: Placebo
- label
- Canakinumab, lyophilizate (LYO)
- type
- ACTIVE_COMPARATOR
- description
- The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
- intervention Names
- Drug: Triamcinolone Acetonide
- Drug: Placebo
- label
- Triamcinolone Acetonide
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Canakinumab, pre-filled syringes (PFS)
- description
- Canakinumab pre-filled syringe
- name
- Canakinumab pre-filled syringe
- type
- DRUG
- arm Group Labels
- Canakinumab, lyophilizate (LYO)
- description
- Canakinumab lyophilized powder
- name
- Canakinumab lyophilized powder
- type
- DRUG
- arm Group Labels
- Triamcinolone Acetonide
- description
- Triamcinolone Acetonide
- name
- Triamcinolone Acetonide
- type
- DRUG
- arm Group Labels
- Canakinumab, lyophilizate (LYO)
- Canakinumab, pre-filled syringes (PFS)
- Triamcinolone Acetonide
- description
- Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide
- name
- Placebo
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- QUADRUPLE
- who Masked
- PARTICIPANT
- CARE_PROVIDER
- INVESTIGATOR
- OUTCOMES_ASSESSOR
- primary Purpose
- TREATMENT
Enrollment
- count
- 397
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
- measure
- Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups
- time Frame
- 72 hours post dose
- secondary Outcomes
- description
- The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Missing pain intensity data at 72 hours was imputed using the Last-Observation-Carried-Forward (LOCF) method.
- measure
- Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups
- time Frame
- 72 hours post dose
- description
- The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity VAS measurements up to 14 days.
- measure
- Patient's Assessment of Pain Intensity on a 0-100mm VAS
- time Frame
- 14 days
- description
- A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme). The scores were measured to the nearest millimeter from the left. The LOCF method was used to impute post-dose pain intensity Likert measurements up to 14 days.
- measure
- Patient's Assessment of Pain Intensity on a 5-point Likert Scale
- time Frame
- 72 hours
- description
- Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely.
- measure
- Number of Patients With at Least One New Gouty Arthritis Flare After Baseline
- time Frame
- 12 weeks
- description
- Patients met the definition of a new flare if they had: a flare in a joint, which was not a previously affected joint (at baseline or during the study), or a flare in a joint previously affected (at baseline or during the study) after the previous flare in that joint had resolved completely according to the patient's perception. Patients did NOT meet the criterion of having a new gout flare if they had increasing/renewed gout pain in an affected joint before the flare had resolved completely. Less than 50% of patients had new flares. Therefore, the median time to new flare could not be calculated.
- measure
- Time to the First New Gouty Arthritis Flare
- time Frame
- 12 weeks
- description
- The Visual Analog Scale (VAS) is an instrument used to measure a person's subjective quantitative evaluation of an item such as pain intensity. The VAS contains a continuous line between two end points whereby the respondent places a mark on the line to indicate his or her response. In this study, patients scored their pain intensity in the most affected joint of the gout flare on a 0 100 mm VAS. The scale ranged from 0 (no pain) to 100 (unbearable pain). The scores were measured to the nearest millimeter from the left. Kaplan Meier estimate of time to 50% reduction in baseline pain, along with associated 95% confidence interval, were reported.
- measure
- Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS
- time Frame
- 14 days
- description
- Patients completed diary entries at 6, 12, 24, 48 and 72 hours post dose and then daily up to 7 days post-dose and/or daily until resolution of the flare. Kaplan Meier estimate of time to resolution of gouty flare as reported by patient, along with associated 95% confiedence interval, were reported.
- measure
- Time to Resolution of Gouty Arthritis Flare as Reported by Patient
- time Frame
- 14 days
- description
- A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Patients scored their response to treatment on a 5-point Likert scale (excellent, good, acceptable, slight, poor). This outcome measure shows the number of patients indicating each score on the scale.
- measure
- Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale
- time Frame
- 72 hours
- description
- A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. The respondent selects the best response that indicates the respondent's subjective evaluation of the item. Study physicians scored their assessment of the patients' response to treatment on a 5-point Likert scale (very good, good, fair, poor, very poor).
- measure
- Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale
- time Frame
- 72 hours
- description
- The study physician assessed the most affected joint for tenderness. Tenderness was measured on a 0 - 3 point scale as follows: 0 = no pain, 1 = patient states that "there is pain", 2 = patient states "there is pain and winces" and 3 = patient states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint.
- measure
- Physician's Assessment of Tenderness
- time Frame
- 72 hours
- description
- The study physician assessed the most affected joint for swelling. 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.
- measure
- Physician's Assessment of Swelling
- time Frame
- 72 hours
- description
- The study physician assessed the most affected joint for erythema. Erythema was assessed as present, absent or not assessable.
- measure
- Physician's Assessment of Erythema
- time Frame
- 72 hours
Full study description
- brief Summary
- This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.
Source references
Source notices and limitations
Discovery and provenance
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- S) and (ii) the time to first new gout flare. The studies aimed to determine whether ILARIS 150 mg would be superior to triamcinolone acetonide 40 mg. Study 3 (NCT01356602), an additional 12-week, randomized, double-blind, active-controlled study, enrolled 397 patients with ILARIS 150 mg subcutaneous (Pre-Filled Syringe (PFS), N=
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Preserved source evidence · Not medical advice