Gouty ArthritisPhase 3NCT01362608
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
A Phase 3 study testing Canakinumab, ACZ885 and Triamcinolone acetonide in people with Gouty Arthritis, run by Novartis Pharmaceuticals at 20 sites in 4 countries.
Trial summary
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Gouty Arthritis
- What is being tested?
- Canakinumab, ACZ885 and Triamcinolone acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 20 sitesin 4 countries
- Study dates
- 20 Jun 2011to 19 May 2015
- Phase
- Phase 3
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meeting diagnosis criteria for acute arthritis of primary gout.
- Start of acute gout flare within 5 days prior to study visit 1
- History of ≥ 3 gout flares within the 12 months prior to study start
- Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines
Who cannot join
- Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide
- Refractory heart failure (Stage D).
- Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
- Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
20 sites in 4 countries.
20 sites in 4 countries
China14 sites
Novartis Investigative Site
Beijing, Beijing Municipality, 100730
Novartis Investigative Site
Beijing, 100029
Novartis Investigative Site
Beijing, 100044
Novartis Investigative Site
Chengdu, Sichuan, 610041
Novartis Investigative Site
Chengdu, Sichuan, 610072
Novartis Investigative Site
Guangzhou, Guangdong, 510080
Novartis Investigative Site
Hangzhou, Zhejiang, 310009
Novartis Investigative Site
Hefei, Anhui, 230001
Novartis Investigative Site
Hefei, Anhui, 230022
Novartis Investigative Site
Nanjing, Jiangsu, 210029
Novartis Investigative Site
Shanghai, 200127
Novartis Investigative Site
Shanghai, 200433
Novartis Investigative Site
Wuhan, 430022
Novartis Investigative Site
Xi’an, Shanxi, 710032
Poland3 sites
Novartis Investigative Site
Katowice, 40-084
Novartis Investigative Site
Poznan, 60-773
Novartis Investigative Site
Wroclaw, 50-349
Singapore2 sites
Novartis Investigative Site
Singapore, 119074
Novartis Investigative Site
Singapore, 529889
Argentina1 site
Novartis Investigative Site
Ciudad Autonoma de Bs As, C1015ABO
About this study
Official title: A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.
- Conditions
- Gouty Arthritis
- Being tested
- Canakinumab, ACZ885, Triamcinolone acetonide
- Keywords
- Gout, Inflammatory gout, acute gout
- Medical subject headings
- Arthritis, Gouty, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Canakinumab, ACZ885Drug
Canakinumab and placebo matching to triamcinolone acetonide
Triamcinolone acetonideDrug
Triamcinolone acetonide 40 mg and placebo matching to canakinumab
| Study group | Role | What they receive |
|---|---|---|
| Canakinumab and placebo matching to triamcinolone acetonide | Experimental | ACZ885H Receives: Drug: Canakinumab, ACZ885 |
| Triamcinolone acetonide 40 mg | Active comparator | ACZ885H Receives: Drug: Triamcinolone acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Measured: at 72 hours post-dose
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
Measured: 12 weeks
Secondary outcomes (14)
The Number of Patients With at Least 1 New Gout Flare
Measured: 12 weeks
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Measured: baseline through 12 weeks
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).
Measured: baseline through week 12
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
Measured: 72 hours through week 12
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Measured: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Measured: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
Measured: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
Measured: baseline through week 12
Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
Kaplan Meier estimate
Measured: 12 weeks
Time to Complete Resolution of Pain: Survival Analysis by Treatment
Kaplan Meier estimate
Measured: 12 weeks
Time to First Rescue Medication Intake
Measured: 12 weeks
Percent Patients Who Took Rescue Medication
Measured: 12 weeks
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
Measured: 12 weeks
High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
Measured: 72 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2011 (estimated)
- Study start20 Jun 2011
- Primary completion19 May 2015
- Study completion19 May 2015
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 Gouty ArthritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 136 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
- NCT01362608
- Sponsor's protocol ID
- CACZ885H2358
- Other IDs
- 2010-024172-26
- Status last verified
- Jun 2017
- First submitted
- 24 May 2011
- Last updated
- 8 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Double-dummy, Active Controlled Study of Canakinumab (ACZ885) on the Treatment and Prevention of Gout Flares in Patients With Frequent Flares for Whom NSAIDs and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
- ClinicalTrials.gov ID
- NCT01362608
- Acronym / sponsor ID
- CACZ885H2358
- Conditions
- Gouty Arthritis
- Keywords
- Gout, Inflammatory gout, acute gout
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2011 (actual)
- Primary completion
- 19 May 2015 (actual)
- Study completion
- 19 May 2015 (actual)
- First posted
- 30 May 2011 (estimated)
- Results
- Posted 8 Jun 2017
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 pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canakinumab and placebo matching to triamcinolone acetonide | Experimental | Drug: Canakinumab, ACZ885ACZ885H |
| Triamcinolone acetonide 40 mg | Active comparator | Drug: Triamcinolone acetonideACZ885H |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meeting diagnosis criteria for acute arthritis of primary gout.
- Start of acute gout flare within 5 days prior to study visit 1
- History of ≥ 3 gout flares within the 12 months prior to study start
- Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines
Key exclusion criteria (6 listed)
- Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide
- Refractory heart failure (Stage D).
- Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
- Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout
- Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
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 |
|---|---|---|
| Canakinumab, ACZ885Canakinumab and placebo matching to triamcinolone acetonide | Drug | Canakinumab and placebo matching to triamcinolone acetonide |
| Triamcinolone acetonideTriamcinolone acetonide 40 mg and placebo matching to canakinumab | Drug | Triamcinolone acetonide 40 mg |
Primary outcome
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)
Time frame: at 72 hours post-dose
A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis
Time frame: 12 weeks
Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks
14 secondary outcomes
The Number of Patients With at Least 1 New Gout Flare
Time frame: 12 weeks
Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment
Time frame: baseline through 12 weeks
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment
Time frame: baseline through week 12
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.
Time frame: 72 hours through week 12
Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment
Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment
Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment
Time frame: baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment
Time frame: baseline through week 12
Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment
Time frame: 12 weeks
Time to Complete Resolution of Pain: Survival Analysis by Treatment
Time frame: 12 weeks
Time to First Rescue Medication Intake
Time frame: 12 weeks
Percent Patients Who Took Rescue Medication
Time frame: 12 weeks
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.
Time frame: 12 weeks
High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose
Time frame: 72 hours post dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- 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
20 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Canakinumab, ACZ885 and Triamcinolone acetonide in people with Gouty Arthritis, run by Novartis Pharmaceuticals at 20 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China, Poland, Singapore, Argentina. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 8 Jun 2017). 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?
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS) (time frame: at 72 hours post-dose). The study lists 2 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 8 Jun 2017.