Acute Gouty Arthritis FlaresPhase 3β-RELIEVEDNCT01470989
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
A Phase 3 study testing ACZ885 and Triamcinolone acetonide 40 mg in people with Acute Gouty Arthritis Flares, run by Novartis Pharmaceuticals at 56 sites in 9 countries.
Trial summary
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Gouty Arthritis Flares
- What is being tested?
- ACZ885 and Triamcinolone acetonide 40 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 56 sitesin 9 countries
- Study dates
- Nov 2011to May 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2
- Patients treated with canakinumab in the core studies or subsequent extensions
Who cannot join
- Pregnant or nursing (lactating) women
Trial locations and contacts
56 sites in 9 countries.
56 sites in 9 countries
United States33 sites
Novartis Investigative Site
Anniston, Alabama, 36207-5710
Novartis Investigative Site
Bristol, Tennessee, 37620
Novartis Investigative Site
Charleston, South Carolina, 29407
Novartis Investigative Site
Charleston, South Carolina, 29412
Novartis Investigative Site
Clarksville, Tennessee, 37043
Novartis Investigative Site
Clearwater, Florida, 33756
Novartis Investigative Site
Columbia, South Carolina, 29204
Novartis Investigative Site
Danville, Virginia, 24541
Novartis Investigative Site
Dayton, Ohio, 45402
Novartis Investigative Site
Decatur, Georgia, 30035
Novartis Investigative Site
Flint, Michigan, 48532
Novartis Investigative Site
Freehold, New Jersey, 07728
Novartis Investigative Site
Hickory, North Carolina, 28602
Novartis Investigative Site
Jackson, Mississippi, 39202
Novartis Investigative Site
Jackson, Mississippi, 39209
Novartis Investigative Site
Johnson City, Tennessee, 37601
Novartis Investigative Site
Jupiter, Florida, 33458
Novartis Investigative Site
Metairie, Louisiana, 70006
Novartis Investigative Site
Missoula, Montana, 59804
Novartis Investigative Site
Mobile, Alabama, 36608
Novartis Investigative Site
Newport News, Virginia, 23606
Novartis Investigative Site
Norwalk, California, 90650
Novartis Investigative Site
Omaha, Nebraska, 68114
Novartis Investigative Site
Opelousas, Louisiana, 70570
Novartis Investigative Site
Overland Park, Kansas, 66215
Novartis Investigative Site
Pasadena, California, 91105
Novartis Investigative Site
San Diego, California, 92108
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Troy, Michigan, 48085
Novartis Investigative Site
Tustin, California, 92780
Novartis Investigative Site
Varnville, South Carolina, 29944
Novartis Investigative Site
Wichita, Kansas, 67208
Novartis Investigative Site
Willoughby Hills, Ohio, 44094
Lithuania5 sites
Novartis Investigative Site
Kaunas, 50009
Novartis Investigative Site
Klaipėda, 92288
Novartis Investigative Site
Šiauliai, LT-76231
Novartis Investigative Site
Vilnius, 09020
Novartis Investigative Site
Vilnius, LT-08661
Russia5 sites
Novartis Investigative Site
Moscow, 115522
Novartis Investigative Site
Petrozavodsk, 185019
Novartis Investigative Site
Saint Petersburg, 190068
Novartis Investigative Site
Yaroslavl, 150003
Novartis Investigative Site
Yekaterinburg, 620219
Canada4 sites
Novartis Investigative Site
Sainte-Foy, Quebec, G1V 3M7
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1B 5E8
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1C 5B8
Novartis Investigative Site
St. John's, Newfoundland and Labrador, A1E 2C2
Germany3 sites
Novartis Investigative Site
Augsburg, 86159
Novartis Investigative Site
Löhne, 32584
Novartis Investigative Site
Magdeburg, 39110
Estonia2 sites
Novartis Investigative Site
Tallinn, 10138
Novartis Investigative Site
Tallinn, 13419
Ukraine2 sites
Novartis Investigative Site
Uzhhorod, 88009
Novartis Investigative Site
Zaporizhzhya, 69035
Australia1 site
Novartis Investigative Site
Darlinghurst, New South Wales, 2010
About this study
Official title: An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 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
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.
- Conditions
- Acute Gouty Arthritis Flares
- Being tested
- ACZ885, Triamcinolone acetonide 40 mg
- Keywords
- gouty arthritis
- Medical subject headings
- Arthritis, Gouty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACZ885Drug
Also called Canakinumab
canakinumab 150 mg s.c., given on demand upon new flares
Triamcinolone acetonide 40 mgDrug
Also called Triamcinolone acetonide
Participants received 40 mg intramuscular (IM)
| Study group | Role | What they receive |
|---|---|---|
| canakinumab | Experimental | canakinumab 150 mg s.c. Receives: Drug: ACZ885; Drug: Triamcinolone acetonide 40 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Measured: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Secondary outcomes (2)
Number of New Flares Per Participant
Flare rate was calculated as the number of new flares over the period of observation in years. New flares occurred before first study medication dose in extension 3 study were considered.
Measured: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Participant scored their current pain intensity in the most affected joint of the gout flare on a 5-point Likert Scale (none or mild).
Measured: up to 7 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionMay 2013
- Study completionMay 2013
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 Acute Gouty Arthritis FlaresStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT01470989
- Sponsor's protocol ID
- CACZ885H2357E3
- Other IDs
- 2011-003414-17
- Acronym
- β-RELIEVED
- Status last verified
- Jun 2021
- First submitted
- 16 Aug 2011
- Last updated
- 9 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Extension Study of CACZ885H2356E2 and CACZ885H2357E2 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
- NCT01470989
- Acronym / sponsor ID
- β-RELIEVED / CACZ885H2357E3
- Conditions
- Acute Gouty Arthritis Flares
- Keywords
- gouty arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| canakinumab | Experimental | Drug: ACZ885, Drug: Triamcinolone acetonide 40 mgcanakinumab 150 mg s.c. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2
- Patients treated with canakinumab in the core studies or subsequent extensions
Key exclusion criteria (1 listed)
- Pregnant or nursing (lactating) women
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 |
|---|---|---|
| ACZ885Also: Canakinumabcanakinumab 150 mg s.c., given on demand upon new flares | Drug | canakinumab |
| Triamcinolone acetonide 40 mgAlso: Triamcinolone acetonideParticipants received 40 mg intramuscular (IM) | Drug | canakinumab |
Primary outcome
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants
Time frame: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline,or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
2 secondary outcomes
Number of New Flares Per Participant
Time frame: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint
Time frame: up to 7 days post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Gouty Arthritis Flares
Not yet recruitingPhase 2
A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
Gout Arthritis
RecruitingPhase 4
Purified Cortrophin® Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
Gout Arthritis, Gout Flare
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
56 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ACZ885 and Triamcinolone acetonide 40 mg in people with Acute Gouty Arthritis Flares, run by Novartis Pharmaceuticals at 56 sites in 9 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 2 inclusion and 1 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 9 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Lithuania, Russia, Canada, Germany and 4 more countries. 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 9 Jul 2021). 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?
Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants (time frame: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)). 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 9 Jul 2021.