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Acute Gouty ArthritisPhase 3NCT01431638

Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

A Phase 3 study testing Canakinumab 150mg in prefilled syringe in people with Acute Gouty Arthritis, run by Novartis Pharmaceuticals at 68 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Acute Gouty Arthritis
What is being tested?
Canakinumab 150mg in prefilled syringe
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
397 participants
Where
68 sitesin 4 countries
Study dates
25 Aug 2011to 9 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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Compliance and completion of the canakinumab PFS core study
  • Unchanged significant clinical medical history from entry into core study

Who cannot join

  • Physician judgment of unsuitability for the study
  • Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

68 sites in 4 countries.

68 sites in 4 countries

United States54 sites

  • Novartis Investigative Site

    Anniston, Alabama, 36207-5710

  • Novartis Investigative Site

    Asheville, North Carolina, 28801

  • Novartis Investigative Site

    Augusta, Georgia, 30904

  • Novartis Investigative Site

    Bedford, Texas, 76021

  • Novartis Investigative Site

    Bellevue, Washington, 98007

  • Novartis Investigative Site

    Belzoni, Mississippi, 39038

  • Novartis Investigative Site

    Bountiful, Utah, 84010

  • Novartis Investigative Site

    Bristol, Tennessee, 37620

  • Novartis Investigative Site

    Buena Park, California, 90620

  • Novartis Investigative Site

    Cary, North Carolina, 27518

  • Novartis Investigative Site

    Chandler, Arizona, 85224

  • Novartis Investigative Site

    Charleston, South Carolina, 29412

  • Novartis Investigative Site

    Charlotte, North Carolina, 28209

  • Novartis Investigative Site

    Columbia, South Carolina, 29204

  • Novartis Investigative Site

    Dallas, Texas, 75231

  • Novartis Investigative Site

    Danville, Virginia, 24541

  • Novartis Investigative Site

    Decatur, Georgia, 30035

  • Novartis Investigative Site

    Duncansville, Pennsylvania, 16635

  • Novartis Investigative Site

    Fargo, North Dakota, 58103

  • Novartis Investigative Site

    Fort Mill, South Carolina, 29707

  • Novartis Investigative Site

    Greensboro, North Carolina, 27401

  • Novartis Investigative Site

    Greer, South Carolina, 29651

  • Novartis Investigative Site

    Gulf Shores, Alabama, 36547

  • Novartis Investigative Site

    Jackson, Mississippi, 39209

  • Novartis Investigative Site

    Johnson City, Tennessee, 37601

  • Novartis Investigative Site

    Jupiter, Florida, 33458

  • Novartis Investigative Site

    Largo, Florida, 33773

  • Novartis Investigative Site

    League City, Texas, 77573

  • Novartis Investigative Site

    Lincoln, Nebraska, 68516

  • Novartis Investigative Site

    Louisville, Kentucky, 40217

  • Novartis Investigative Site

    Memphis, Tennessee, 38125

  • Novartis Investigative Site

    Metairie, Louisiana, 70006

  • Novartis Investigative Site

    Midlothian, Virginia, 23114

  • Novartis Investigative Site

    Mineola, New York, 11501

  • Novartis Investigative Site

    Missoula, Montana, 59804

  • Novartis Investigative Site

    Mobile, Alabama, 36608

  • Novartis Investigative Site

    Mogadore, Ohio, 44260

  • Novartis Investigative Site

    New Hyde Park, New York, 11042

  • Novartis Investigative Site

    Newport News, Virginia, 23606

  • Novartis Investigative Site

    Norwalk, California, 90650

  • Novartis Investigative Site

    Omaha, Nebraska, 68114

  • Novartis Investigative Site

    Omaha, Nebraska, 68134

  • Novartis Investigative Site

    Owensboro, Kentucky, 42303

  • Novartis Investigative Site

    Picayune, Mississippi, 39466

  • Novartis Investigative Site

    Roslyn, New York, 11576

  • Novartis Investigative Site

    Salisbury, North Carolina, 28144

  • Novartis Investigative Site

    Scottsdale, Arizona, 85251

  • Novartis Investigative Site

    Shelby, North Carolina, 28152

  • Novartis Investigative Site

    South Miami, Florida, 33143

  • Novartis Investigative Site

    Topeka, Kansas, 66606

  • Novartis Investigative Site

    Troy, Michigan, 48085

  • Novartis Investigative Site

    Varnville, South Carolina, 29944

  • Novartis Investigative Site

    Westlake Village, California, 91361

  • Novartis Investigative Site

    Wilmington, North Carolina, 28401

Other trials in United States

Lithuania6 sites

  • Novartis Investigative Site

    Kaunas, LT, 51349

  • Novartis Investigative Site

    Kaunas, LT, LT-50128

  • Novartis Investigative Site

    Klaipėda, LT-92288

  • Novartis Investigative Site

    Vilnius, LT, 01117

  • Novartis Investigative Site

    Vilnius, 09310

  • Novartis Investigative Site

    Vilnius, LT-08661

Other trials in Lithuania

Germany5 sites

  • Novartis Investigative Site

    Berlin, 10117

  • Novartis Investigative Site

    Löhne, 32584

  • Novartis Investigative Site

    Magdeburg, 39110

  • Novartis Investigative Site

    Regensburg, Bavaria, 93053

  • Novartis Investigative Site

    Weener, 26826

Other trials in Germany

Canada3 sites

  • Novartis Investigative Site

    Sainte-Foy, Quebec, G1V 3M7

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1A 5E8

  • Novartis Investigative Site

    St. John's, Newfoundland and Labrador, A1E 2C2

Other trials in Canada

About this study

Official title: A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients

This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Being tested
Canakinumab 150mg in prefilled syringe
Keywords
Gout, arthritis, gout flare, acute gout, gouty, rheumatic disease, uric acid, podagra
Medical subject headings
Gout, Arthritis, Rheumatic Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Canakinumab 150mg in prefilled syringeDrug

    Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares

Study groups in NCT01431638
Study groupRoleWhat they receive
Canakinumab 150mgExperimentalCanakinumab 150mg in prefilled syringe subcutaneously
Receives: Drug: Canakinumab 150mg in prefilled syringe

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Reported Adverse Events

    Measured: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)

Secondary outcomes (7)

  1. Probability of New Gout Flares at End of Study

    The Kaplan-Meier estimates of the proportion of participants with first new gout flare, along with the associated 95% confidence intervals using Greenwood's formula were reported. The first new flare was observed either in the core or extension of the study right prior to the switch. The results were reported as Kaplan-Meier estimates.

    Measured: Up to Day 337

  2. Number of Participant With New Flares

    The flare rate was calculated as the number of new flares over the period of observation in years. New flares that occurred before the first study medication dose in the extension 1 study were considered.

    Measured: up to 36 weeks

  3. Change From Baseline in Pain Intensity on a 5-point Likert Scale

    A Likert scale is a type of scale with a range of responses corresponding to an item such as pain. Participants were advised to score their current pain intensity in the most affected joint of the gouty arthritis flare on a 5-point Likert scale of 1 (None) to 5 (extreme pain), where; 1= none, 2= mild pain, 3= moderate pain, 4= severe pain, or 5= extreme pain (none, mild, moderate, severe, extreme). The higher value presented on the scale was the outcome (high intensity of pain). The respondent selects the best response that indicates the respondent's subjective evaluation of the item. The Last-observation-carried-forward (LOCF) method was used to impute post-dose pain intensity Likert measurements up to 14 days.

    Measured: Baseline, upto 14 days post-dose

  4. Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time

    Patients scored their current pain intensity in the most affected joint of the current gouty arthritis flare on a 0-100 VAS, ranging from no pain (0) to unbearable pain (100). Scores on the 100 mm linear scale were measured to the nearest millimeter from the left.

    Measured: Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose

  5. Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment

    Participants were advised to make a global assessment of response to treatment using a 5-point Likert scale (1=excellent, 2=good, 3=acceptable, 4=slight, 5=poor).

    Measured: 48 weeks post-dose

  6. Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint

    Tenderness was measured on a 0-3 point scale: no pain, participant states that "there is pain", participant states "there is pain and winces" and participant states "there is pain, winces and withdraws" on palpation or passive movement of the affected study joint. Swelling was measured on a 0 - 3 point scale as follows: 0 = no swelling, 1 = palpable, 2= visible and 3 = bulging beyond the joint margins. Erythema was assessed as present, absent or not assessable.

    Measured: Baseline, 7 days post-dose

  7. Number of Participants Responded for Physician's Global Assessment of Response to Treatment

    The physician made a global assessment of the participant's response to treatment using a 5-point Likert scale: 1=very good, 2=good, 3=fair, 4=poor, 5=very poor.

    Measured: 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.

  1. First posted9 Sep 2011 (estimated)
  2. Study start25 Aug 2011
  3. Primary completion9 May 2013
  4. Study completion9 May 2013

Resources

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
Model description
Uncontrolled
Masking
None (open label)
Enrolment
397 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01431638
Sponsor's protocol ID
CACZ885H2361E1
Other IDs
2011-001342-15
Status last verified
Jun 2021
First submitted
30 Aug 2011
Last updated
19 Jul 2021
Data monitoring committee
Yes
Individual data sharing
Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Canakinumab 150mg in prefilled syringe in people with Acute Gouty Arthritis, run by Novartis Pharmaceuticals at 68 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 2 inclusion and 2 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 19 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 68 sites in United States, Lithuania, Germany, Canada. 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 19 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 Participants Who Reported Adverse Events (time frame: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01431638.

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 19 Jul 2021.

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