OsteoarthritisPhase 2NCT01160822
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
A Phase 2 study testing Canakinumab and Naproxen in people with Osteoarthritis, run by Novartis Pharmaceuticals at 13 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Canakinumab and Naproxen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 13 sitesin 4 countries
- Study dates
- Apr 2010to Jul 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
13 sites in 4 countries.
13 sites in 4 countries
United States8 sites
Pinnacle Research Group, LLC
Anniston, Alabama, 36207
Rush-Presbyterian St. Lukes Medical Center
Chicago, Illinois, 60612
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Volunteer Research Group
Knoxville, Tennessee, 37920
Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona, 85202
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92108
Cotton O'Neil Clinical Research Institute
Topeka, Kansas, 66606
Westlake Medical Research
Westlake Village, California, 91361
Finland2 sites
Novartis Investigative site
Helsinki
Novartis Investigative site
Kuopio
Germany2 sites
Novartis Investigative site
Berlin
Novartis Investigative site
Erlangen
About this study
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
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.
Read the 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
- Osteoarthritis
- Being tested
- Canakinumab, Placebo to canakinumab, Naproxen, Placebo to Naproxen
- Keywords
- Osteo arthritis, pain control, intra- articular injections, Knee OA
- Medical subject headings
- Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CanakinumabBiological
Also called ACZ885
Intra-articular injection
Placebo to canakinumabDrug
Intra-articular injection
NaproxenDrug
Tablets for oral administration
Placebo to NaproxenDrug
Tablets for oral administration
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Canakinumab |
| Part A: Placebo | Placebo comparator | Participants received a single intra-articular injection of canakinumab-matching placebo. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo to canakinumab; Drug: Naproxen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline and Week 4
Secondary outcomes (21)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12
Maximum Observed Plasma Concentration of Canakinumab (Cmax)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160822
- Sponsor's protocol ID
- CACZ885C2201
- Other IDs
- 2009-015017-48, 2009
- Status last verified
- Sep 2012
- First submitted
- 9 Jul 2010
- Last updated
- 30 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01160822
- Acronym / sponsor ID
- CACZ885C2201
- Conditions
- Osteoarthritis
- Keywords
- Osteo arthritis, pain control, intra- articular injections, Knee OA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 12 Jul 2010 (estimated)
- Results
- Posted 30 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part A: Canakinumab | Experimental | Biological: CanakinumabIn 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. |
| Part A: Placebo | Placebo comparator | Drug: Placebo to canakinumabParticipants received a single intra-articular injection of canakinumab-matching placebo. |
| Part B: Canakinumab | Experimental | Biological: Canakinumab, Drug: Placebo to NaproxenParticipants received a single intra-articular injection of canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. |
| Part B: Placebo | Placebo comparator | Drug: Placebo to canakinumab, Drug: Placebo to NaproxenParticipants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks. |
| Part B: Naproxen | Active comparator | Drug: Placebo to canakinumab, Drug: NaproxenParticipants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CanakinumabAlso: ACZ885Intra-articular injection | Biological | Part A: Canakinumab, Part B: Canakinumab |
| Placebo to canakinumabIntra-articular injection | Drug | Part A: Placebo, Part B: Naproxen, Part B: Placebo |
| NaproxenTablets for oral administration | Drug | Part B: Naproxen |
| Placebo to NaproxenTablets for oral administration | Drug | Part B: Canakinumab, Part B: Placebo |
Primary outcome
Part A: Number of Participants With Intolerance Events
Time frame: Baseline to Day 3
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.
Part B: Change From Baseline to Day 4 in Pain Using 100 mm Visual Analog Scale (VAS)
Time frame: Baseline and Day 4
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.
Part B: Change From Baseline to Week 4 in Western Ontario and McMaster Osteoarthritis Index (WOMAC) Pain Subscale
Time frame: Baseline and Week 4
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.
21 secondary outcomes
Part B: Change From Baseline in Pain Using 100 mm Visual Analog Scale (VAS)
Time frame: Baseline and Weeks 4, 8 and 12
Part B: Percentage of Responders in the Pain 100 mm Visual Analog Scale (VAS)
Time frame: Baseline, Day 4, Weeks 1, 2, 4, 8 and 12
Part B: Change From Baseline in WOMAC Pain, Stiffness and Physical Function Subscales
Time frame: Baseline and Weeks 4, 8 and 12
Part B: Proportion of Participants Who Used Rescue Analgesic During Study
Time frame: Day 4, Weeks 1, 2, 4, 8 and 12
Patient's Global Assessment of Response to Treatment on Day 4
Time frame: Day 4
Patient's Global Assessment of Response to Treatment at Week 2
Time frame: Week 2
Patient's Global Assessment of Response to Treatment at Week 4
Time frame: Week 4
Patient's Global Assessment of Response to Treatment at Week 8
Time frame: Week 8
Patient's Global Assessment of Response to Treatment at Week 12
Time frame: Week 12
Part B: Physician's Global Assessment of Response to Treatment at Day 4
Time frame: Day 4
Part B: Physician's Global Assessment of Response to Treatment at Week 2
Time frame: Week 2
Part B: Physician's Global Assessment of Response to Treatment at Week 4
Time frame: Week 4
Part B: Physician's Global Assessment of Response to Treatment at Week 8
Time frame: Week 8
Part B: Physician's Global Assessment of Response to Treatment at Week 12
Time frame: Week 12
Maximum Observed Plasma Concentration of Canakinumab (Cmax)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
13 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Canakinumab and Naproxen in people with Osteoarthritis, run by Novartis Pharmaceuticals at 13 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in United States, Finland, Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of Participants With Intolerance Events (time frame: Baseline to Day 3). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2012.