To Determine the Safety, Tolerability, Pharmacokinetics a... | NCT01160822 | Trialant
NCT01160822
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Oct 30, 2012Estimated
Enrollment
169Actual
Phase
Phase 2
Conditions
Osteoarthritis
Interventions
Canakinumab
Placebo to canakinumab
Naproxen
Placebo to Naproxen
Countries
United States
Finland
France
Germany
Protocol Section
Identification Module
NCT ID
NCT01160822
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CACZ885C2201
Secondary IDs
ID
Type
Description
Link
2009-015017-48
EudraCT Number
Brief Title
To Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee
Official Title
A Randomized, Double Blind, Placebo and Naproxen Controlled, Multi-center, Study to Determine the Safety, Tolerability, Pharmacokinetics and Effect on Pain of a Single Intra-articular Administration of Canakinumab in Patients With Osteoarthritis in the Knee
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Sep 2012
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 2010
Primary Completion Date
Jul 2011Actual
Completion Date
Jul 2011Actual
First Submitted Date
Jul 9, 2010
First Submission Date that Met QC Criteria
Jul 9, 2010
First Posted Date
Jul 12, 2010Estimated
Results Waived
Not provided
Results First Submitted Date
Jul 26, 2012
Results First Submitted that Met QC Criteria
Jul 26, 2012
Results First Posted Date
Aug 30, 2012Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 28, 2012
Last Update Posted Date
Oct 30, 2012Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
The purpose of this study was to determine whether, in patients with mild to moderate knee osteoarthritis, canakinumab is safe and tolerable when injected intra-articularly.
Detailed Description
This is a randomized, double-blind, parallel group, placebo controlled 18 weeks study, consisting of two parts:
Part A: an ascending single dose part in which the safety and tolerability of up to 4 different canakinumab doses are studied (starting dose 150 mg, maximum dose 600 mg).
Part B: a double-dummy, active-controlled, parallel design part in which the pain reduction of the canakinumab dose selected from part A is studied in comparison to Placebo and Naproxen.
Conditions Module
Conditions
Osteoarthritis
Keywords
Osteo arthritis
pain control
intra- articular injections
Knee OA
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
169Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Canakinumab
Experimental
In this ascending dose part, participants received a single intra-articular injection of canakinumab. The beginning dose was 150 mg, escalating to the 300 mg dose and then to 600 mg.
Biological: Canakinumab
Part A: Placebo
Placebo Comparator
Participants received a single intra-articular injection of canakinumab-matching placebo.
Drug: Placebo to canakinumab
Part B: Canakinumab
Experimental
Participants received a single intra-articular injection of canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Biological: Canakinumab
Drug: Placebo to Naproxen
Part B: Placebo
Placebo Comparator
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Drug: Placebo to canakinumab
Drug: Placebo to Naproxen
Part B: Naproxen
Active Comparator
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Canakinumab
Biological
Intra-articular injection
Part A: Canakinumab
Part B: Canakinumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Number of Participants With Intolerance Events
An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline VAS pain score is ≥ 80 mm, an intolerance event is defined as an increase in pain by 10 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline pain score is ≥ 90 mm, an intolerance event is defined as the patients experiencing an unspecified increase in pain on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection.
Baseline to Day 3
Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)
After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). A negative change from Baseline score indicates improvement.
Results are from a Bayesian analysis of covariance (ANCOVA) model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and subject as random effects.
Baseline and Day 4
Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale
The Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale asks patients to rate pain in the index knee joint in the last 48 hours doing different activities on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0 to 20, where higher scores indicate more pain. A negative change from Baseline score indicates improvement.
Results are from a Bayesian ANCOVA model, fitting baseline WOMAC pain score as a covariate, time by treatment as fixed effects, region and patient as random effects.
Secondary Outcomes
Measure
Description
Time Frame
Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)
After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).
Results are from a Bayesian ANCOVA model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and patient as random effects.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Written informed consent must be obtained before any assessment is performed.
Male and female patients aged 40 - 80 years (inclusive).
Diagnosis of knee osteoarthritis
Radiographic evidence of tibiofemoral compartment osteoarthritis
Pain in the knee during the last 24 hours.The patients should also have had pain in the affected knee on most days over the last month.
Patients who are willing to discontinue all non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesic medication taken for any condition, including their knee pain,
Patients who are on stable dose of opioids for at least 1 month before screening can continue to take their opioid at this stable dose throughout the study.
Patients must also be willing to abstain from any intra-articular or peri-articular injections to the knee or surgery during the treatment period
Patients who, if they are currently taking aspirin (325 mg/day or less; as anti-coagulants), are willing to remain on a stable dose one month prior to screening and throughout the study
Exclusion Criteria:
Subjects with known hypersensitivity to any biological or investigational drugs.
Patients with contraindications to knee injections
Patients with joint effusion
Patients should not have rheumatoid arthritis or any connective tissue like disease
Secondary osteoarthritis with history and/or any evidence of the following diseases: septic arthritis, inflammatory joint disease, gout, Paget's disease of the bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary osteochondromatosis, juvenile chronic arthritis with continued activity in adulthood, heritable disorders (e.g. hypermobility). Patients with secondary osteoarthritis following menisectomy or injuries of a collateral or cruciate ligament are not excluded.
Presence or history of underlying metabolic, endocrine, hematologic, pulmonary, cardiac, blood, renal, hepatic, infectious, psychiatric or gastrointestinal conditions
Evidence of tuberculosis (TB)
One of the risk factors for TB such as:
Substance abuse (e.g. injection or non-injection)
Health-care workers with unprotected exposure to patients who are at high risk of TB
Patients with TB disease before the identification and correct airborne precautions of the patient
close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease.
Significant medical problems, including but not limited to the following: uncontrolled hypertension,congestive heart failure, uncontrolled diabetes type I and II
Subjects with evidence of hepatic or blood coagulation disorders (i.e. hemophilia, etc), anemia, idiopathic thrombocytopenic purpura, or gastrointestinal disorder: severe hepatic disease, history of alcohol and drug abuse; disease of gall bladder and pancreas; active peptic ulceration, gastrointestinal bleeding or history of severe gastro-esophageal reflux disease or severe hiatus hernia; inflammatory bowel disease.
Use of any therapeutic protein drug (e.g. anti-tumor necrosis factor alpha (TNFα) antibody)
Presence of severe renal function impairment. History of renal trauma, glomerulonephritis, patients with one kidney, or renal failure requiring regular dialysis treatment.
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 pregnancy test (serum or urine).
Subjects with known contra-indications to naproxen (e.g. heart or circulation problems, history of ulcer disease etc.), analgesics, antipyretics, or NSAIDs.
Disease of the spine or other lower extremity joints which may interfere with the assessment of the target joint.
Surgery on the knee within the last year. Observational arthroscopy, arthroscopic surgery or lavage of the knee within the last 6 months.
Use of assistive devices other than a cane (walking stick) or knee brace.
Subjects who have experienced, any time in the past, asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reaction after taking acetylsalicylic acid (ASA)/ aspirin or NSAIDs.
Any history of prior peptic ulcer disease or prior NSAID gastrointestinal complications for the past 5 years.
Other protocol defined inclusion/exclusion criteria may apply.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
40 Years
Maximum Age
80 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Pinnacle Research Group, LLC
Anniston
Alabama
36207
United States
Arizona Arthritis & Rheumatology Research, PLLC
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
FG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Turkey (Türkiye)
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Drug: Placebo to canakinumab
Drug: Naproxen
ACZ885
Placebo to canakinumab
Drug
Intra-articular injection
Part A: Placebo
Part B: Naproxen
Part B: Placebo
Naproxen
Drug
Tablets for oral administration
Part B: Naproxen
Placebo to Naproxen
Drug
Tablets for oral administration
Part B: Canakinumab
Part B: Placebo
Baseline and Week 4
Baseline and Weeks 4, 8 and 12
Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)
A responder is defined as a participant with a 50% or greater reduction from baseline on the VAS scale for pain assessment. After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).
Baseline, Day 4, Weeks 1, 2, 4, 8 and 12
Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales
The WOMAC consists of 3 subscales:
The Pain subscale asks patients to rate pain in the index knee joint in the last 48 hours during walking, using stairs, in bed, sitting or lying, and standing on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0-20.
The Stiffness subscale assesses stiffness in the index knee joint during the last 48 hours doing different activities on a scale from none (0) to extreme stiffness (4). The total stiffness subscale score ranges from 0-8.
The Physical Function subscale assesses difficulty performing daily physical activities during the last 48 hours on a scale from none (0) to extreme difficulty (4). The total physical function subscale score ranges from 0-68.
Higher scores indicate more pain/stiffness/difficulty. Results are from a Bayesian ANCOVA model, with baseline WOMAC score as a covariate, time by treatment as fixed effects, region and patient as random effects.
Baseline and Weeks 4, 8 and 12
Part B: Proportion of Participants Who Used Rescue Analgesic During Study
Participants were permitted to take oral rescue medication (Acetaminophen ≤ 4 gram/day) up until 24 hours of a scheduled assessment visit during the 12-week treatment period. The estimates shown are the Kaplan-Meier estimates of the proportion of participants that took rescue medication.
Day 4, Weeks 1, 2, 4, 8 and 12
Patient's Global Assessment of Response to Treatment on Day 4
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Day 4
Patient's Global Assessment of Response to Treatment at Week 2
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Week 2
Patient's Global Assessment of Response to Treatment at Week 4
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Week 4
Patient's Global Assessment of Response to Treatment at Week 8
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Week 8
Patient's Global Assessment of Response to Treatment at Week 12
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Week 12
Part B: Physician's Global Assessment of Response to Treatment at Day 4
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Day 4
Part B: Physician's Global Assessment of Response to Treatment at Week 2
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Week 2
Part B: Physician's Global Assessment of Response to Treatment at Week 4
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Week 4
Part B: Physician's Global Assessment of Response to Treatment at Week 8
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Week 8
Part B: Physician's Global Assessment of Response to Treatment at Week 12
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Week 12
Maximum Observed Plasma Concentration of Canakinumab (Cmax)
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Terminal Phase Half-life (t1/2) of Canakinumab
The time it takes for the concentration level of canakinumab to fall to 50% of the original value.
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Apparent Clearance of Canakinumab From Plasma (CL/F)
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Apparent Volume of Distribution During Terminal Phase (Vz/F)
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
Participants received a single intra-articular injection of 600 mg canakinumab.
FG003
Part A: Placebo
Participants received a single intra-articular injection of canakinumab-matching placebo.
FG004
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
FG005
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
FG006
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
FG0006 subjects
FG0017 subjects
FG0026 subjects
FG0035 subjects
FG00445 subjects
FG00547 subjects
FG00653 subjects
COMPLETED
FG0006 subjects
FG0017 subjects
FG0026 subjects
FG0035 subjects
FG00436 subjects
FG00540 subjects
FG00644 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0049 subjects
FG0057 subjects
FG0069 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0052 subjects
FG0065 subjects
Unsatisfactory therapeutic effect
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Administrative problems
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Protocol deviation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
BG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
BG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
BG003
Part A: Placebo
Participants received a single intra-articular injection of canakinumab-matching placebo.
BG004
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
BG005
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
BG006
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
BG007
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0006
BG0017
BG0026
BG0035
BG00445
BG00547
BG00653
BG007169
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00058.3± 12.79
BG00161.0± 9.63
BG00264.2± 10.68
BG003
Age, Customized
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG000NA± NAAge demographic data for Study Part B.
BG001NA± NAAge demographic data for Study Part B.
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0003
BG0014
BG002
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
Part A: Number of Participants With Intolerance Events
An intolerance event is defined as an acute inflammatory reaction, characterized by a 30 mm increase in pain (on a 100 mm visual analog scale (VAS) and associated with a new or worsened synovial fluid effusion within 3 days following the intra-articular (i.a.) injection. If baseline VAS pain score is ≥ 70 mm, an intolerance event is defined as an increase in pain by 20 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline VAS pain score is ≥ 80 mm, an intolerance event is defined as an increase in pain by 10 mm on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection. If baseline pain score is ≥ 90 mm, an intolerance event is defined as the patients experiencing an unspecified increase in pain on a 100 mm VAS associated with new or worsened synovial fluid effusion within 3 days following the i.a. injection.
Safety analysis set.
Posted
Number
participants
Baseline to Day 3
ID
Title
Description
OG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
OG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
OG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
OG003
Part A: Placebo
Participants received a single intra-articular injection of canakinumab-matching placebo.
Units
Counts
Participants
OG0006
OG0017
OG0026
OG003
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG003
Primary
Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)
After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm). A negative change from Baseline score indicates improvement.
Results are from a Bayesian analysis of covariance (ANCOVA) model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and subject as random effects.
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Day 4
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Primary
Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale
The Western Ontario and McMaster osteoarthritis Index (WOMAC) pain subscale asks patients to rate pain in the index knee joint in the last 48 hours doing different activities on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0 to 20, where higher scores indicate more pain. A negative change from Baseline score indicates improvement.
Results are from a Bayesian ANCOVA model, fitting baseline WOMAC pain score as a covariate, time by treatment as fixed effects, region and patient as random effects.
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data, and where data were available.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Week 4
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Secondary
Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)
After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).
Results are from a Bayesian ANCOVA model, fitting baseline pain VAS score as a covariate, time by treatment as fixed effects, region and patient as random effects.
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 4, 8 and 12
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Secondary
Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)
A responder is defined as a participant with a 50% or greater reduction from baseline on the VAS scale for pain assessment. After walking for 20 meters, participants were asked to assess the pain in their affected knee on a 100 mm linear visual analog scale ranging from no pain (0 mm) to unbearable pain (100 mm).
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data. N is the number of participants with available data at each time point.
Posted
Number
percentage of participants
Baseline, Day 4, Weeks 1, 2, 4, 8 and 12
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Secondary
Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales
The WOMAC consists of 3 subscales:
The Pain subscale asks patients to rate pain in the index knee joint in the last 48 hours during walking, using stairs, in bed, sitting or lying, and standing on a scale from none (0) to extreme pain (4). The answers are summed and the total pain subscale score ranges from 0-20.
The Stiffness subscale assesses stiffness in the index knee joint during the last 48 hours doing different activities on a scale from none (0) to extreme stiffness (4). The total stiffness subscale score ranges from 0-8.
The Physical Function subscale assesses difficulty performing daily physical activities during the last 48 hours on a scale from none (0) to extreme difficulty (4). The total physical function subscale score ranges from 0-68.
Higher scores indicate more pain/stiffness/difficulty. Results are from a Bayesian ANCOVA model, with baseline WOMAC score as a covariate, time by treatment as fixed effects, region and patient as random effects.
Pharmacodynamic (PD) analysis set - Patients with any available PD data and no major protocol deviations with impact on PD data.
Posted
Mean
Standard Deviation
units on a scale
Baseline and Weeks 4, 8 and 12
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Secondary
Part B: Proportion of Participants Who Used Rescue Analgesic During Study
Participants were permitted to take oral rescue medication (Acetaminophen ≤ 4 gram/day) up until 24 hours of a scheduled assessment visit during the 12-week treatment period. The estimates shown are the Kaplan-Meier estimates of the proportion of participants that took rescue medication.
Safety analysis set (all participants as assigned that received at least one dose of study drug).
Posted
Number
proportion of participants
Day 4, Weeks 1, 2, 4, 8 and 12
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Secondary
Patient's Global Assessment of Response to Treatment on Day 4
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Day 4
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Patient's Global Assessment of Response to Treatment at Week 2
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Week 2
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Patient's Global Assessment of Response to Treatment at Week 4
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Week 4
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Patient's Global Assessment of Response to Treatment at Week 8
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Week 8
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Patient's Global Assessment of Response to Treatment at Week 12
Participants made a global assessment of their response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Week 12
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Part B: Physician's Global Assessment of Response to Treatment at Day 4
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Day 4
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Part B: Physician's Global Assessment of Response to Treatment at Week 2
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Week 2
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Part B: Physician's Global Assessment of Response to Treatment at Week 4
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Week 4
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Part B: Physician's Global Assessment of Response to Treatment at Week 8
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Week 8
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Part B: Physician's Global Assessment of Response to Treatment at Week 12
The study physician made a global assessment of response to treatment using a 5-point Likert scale: Excellent, Good, Acceptable, Poor, Very Poor.
Pharmacodynamic analysis set, where data were available.
Posted
Number
participants
Week 12
ID
Title
Description
OG000
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG001
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Secondary
Maximum Observed Plasma Concentration of Canakinumab (Cmax)
Pharmacokinetic analysis set where data were available.
Posted
Mean
Standard Deviation
µg/mL
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
ID
Title
Description
OG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
OG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
OG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
OG003
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Secondary
Time to Reach the Maximum Observed Plasma Concentration of Canakinumab (Tmax)
Pharmacokinetic analysis set where data were available.
Posted
Median
Full Range
hours
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
ID
Title
Description
OG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
OG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
OG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
OG003
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Secondary
Area Under the Concentration Time Curve up to the Last Measurable Concentration (AUClast)
Pharmacokinetic analysis set where data were available.
Posted
Mean
Standard Deviation
µg*day/mL
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
ID
Title
Description
OG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
OG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
OG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
OG003
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Secondary
Area Under the Concentration Time Curve From Time Zero to Infinity AUC(0-inf)
Pharmacokinetic analysis set where data were available.
Posted
Mean
Standard Deviation
µg*day/mL
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
ID
Title
Description
OG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
OG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
OG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
OG003
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Secondary
Terminal Phase Half-life (t1/2) of Canakinumab
The time it takes for the concentration level of canakinumab to fall to 50% of the original value.
Pharmacokinetic analysis set where data were available.
Posted
Mean
Standard Deviation
hours
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
ID
Title
Description
OG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
OG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
OG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
OG003
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Secondary
Apparent Clearance of Canakinumab From Plasma (CL/F)
Pharmacokinetic analysis set, where data were available.
Posted
Mean
Standard Deviation
mL/hr
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
ID
Title
Description
OG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
OG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
OG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
OG003
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Secondary
Apparent Volume of Distribution During Terminal Phase (Vz/F)
Pharmacokinetic analysis set, where data were available.
Posted
Mean
Standard Deviation
mL
Day 1, pre-dose and 1, 3, 6 and 8 hours post-dose (Part A only), Day 2, 4, 8, 15, 29, 57, 85 and 126.
ID
Title
Description
OG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
OG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
OG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
OG003
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: Canakinumab 150 mg
Participants received a single intra-articular injection of 150 mg canakinumab.
0
6
4
6
EG001
Part A: Canakinumab 300 mg
Participants received a single intra-articular injection of 300 mg canakinumab.
0
7
4
7
EG002
Part A: Canakinumab 600 mg
Participants received a single intra-articular injection of 600 mg canakinumab.
1
6
3
6
EG003
Part A: Placebo
Participants received a single intra-articular injection of canakinumab-matching placebo.
1
5
3
5
EG004
Part B: Canakinumab
Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
0
45
17
45
EG005
Part B: Placebo
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
4
47
25
47
EG006
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
4
53
26
53
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG0030 affected5 at risk
EG0040 affected45 at risk
EG0051 affected47 at risk
EG0060 affected53 at risk
Small intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Tooth infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Meniscus lesion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Dehydration
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cerumen impaction
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG0031 affected5 at risk
EG0040 affected45 at risk
EG0050 affected47 at risk
EG0060 affected53 at risk
Retinal tear
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Chest discomfort
General disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Cellulitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Staphylococcal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Tooth abscess
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Arthropod sting
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Fluid retention
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0012 affected7 at risk
EG0021 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Joint swelling
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Neuropathic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected7 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0001 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Seborrhoea
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected7 at risk
EG0021 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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 (i.e., data from all sites) in the clinical trial.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceuticals
862-778-8300
ID
Term
D010003
Osteoarthritis
D000377
Agnosia
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D010468
Perceptual Disorders
D019954
Neurobehavioral Manifestations
D009461
Neurologic Manifestations
D009422
Nervous System Diseases
D012816
Signs and Symptoms
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C541220
canakinumab
D009288
Naproxen
Ancestor Terms
ID
Term
D009280
Naphthaleneacetic Acids
D009281
Naphthalenes
D011084
Polycyclic Aromatic Hydrocarbons
D006841
Hydrocarbons, Aromatic
D006844
Hydrocarbons, Cyclic
D006838
Hydrocarbons
D009930
Organic Chemicals
D011083
Polycyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
4 subjects
FG0055 subjects
FG0063 subjects
0 subjects
FG0050 subjects
FG0061 subjects
1 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0050 subjects
FG0060 subjects
2 subjects
FG0050 subjects
FG0060 subjects
57.8
± 7.76
BG004NA± NAAge demographic data for Study Part A.
BG005NA± NAAge demographic data for Study Part A.
BG006NA± NAAge demographic data for Study Part A.
BG00760.5± 10.07
NA
± NA
Age demographic data for Study Part B.
BG003NA± NAAge demographic data for Study Part B.
BG00461.4± 8.96
BG00560.3± 9.71
BG00662.2± 8.10
BG00761.3± 8.89
2
BG0032
BG00431
BG00531
BG00634
BG007107
Male
BG0003
BG0013
BG0024
BG0033
BG00414
BG00516
BG00619
BG00762
5
0
Units
Counts
Participants
OG00042
OG00144
OG00249
Title
Denominators
Categories
Title
Measurements
OG000-26.7± 4.05
OG001-26.5± 3.97
OG002-27.6± 3.82
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
Units
Counts
Participants
OG00042
OG00144
OG00248
Title
Denominators
Categories
Title
Measurements
OG000-3.5± 0.71
OG001-4.0± 0.68
OG002-4.5± 0.65
Units
Counts
Participants
OG00043
OG00144
OG00249
Title
Denominators
Categories
Week 4
Title
Measurements
OG000-25.6± 4.03
OG001-31.1± 4.03
OG002-36.1± 3.84
Week 8
Title
Measurements
OG000-26.2± 4.12
OG001-30.9± 4.06
OG002-33.0± 3.89
Week 12
Title
Measurements
OG000-25.1± 4.14
OG001-32.1± 4.06
OG002-27.8± 3.94
Units
Counts
Participants
OG00043
OG00144
OG00249
Title
Denominators
Categories
Day 4 [N=42, 44, 48]
Title
Measurements
OG00050.0
OG00143.2
OG00247.9
Week 1 [N=42, 44, 48]
Title
Measurements
OG00040.5
OG00145.5
OG00256.3
Week 2 [N=41, 44, 48]
Title
Measurements
OG00046.3
OG00143.2
OG00262.5
Week 4 [N=39, 40, 46]
Title
Measurements
OG00051.3
OG00155.0
OG00271.7
Week 8 [N=36, 38, 43]
Title
Measurements
OG00052.8
OG00150.0
OG00255.8
Week 12 [N=35, 37, 41]
Title
Measurements
OG00048.6
OG00151.4
OG00253.7
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
OG002
Part B: Naproxen
Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.