Long Term Study of Canakinumab (ACZ885) in Patients With Gout

June 10, 2021 updated by: Novartis Pharmaceuticals

A 24-week Open-label, Multicenter, Follow-up and Extension Study to CACZ885H2251, to Assess Safety, Tolerability and Efficacy of Canakinumab (ACZ885) in Patients With Gout Who Were Given Canakinumab at the Time of Gout Flare

This 24-week open-label extension study is designed to provide additional long-term safety data up to a total of 1-year for patients rolling over from the core study, and to collect further efficacy and tolerability data for all the patients, irrespective whether they have an acute flare of gout or not. Patients will be treated on demand with canakinumab (ACZ885) in this extension study.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
341

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Capital Federal Buenos Aires, Argentina, 1027
        • Novartis Investigative Site
  • Belgium
      • Jette, Belgium, 1090
        • Novartis Investigative Site
  • Colombia
      • Barranquilla, Colombia
        • Novartis Investigative Site
      • Bogotá, Colombia
        • Novartis Investigative Site
      • Bucaramanga, Colombia
        • Novartis Investigative Site
      • Floridablanca, Colombia
        • Novartis Investigative Site
  • Czechia
    • Czech Republic
      • Praha 5, Czech Republic, Czechia, 15006
        • Novartis Investigative Site
  • Germany
    • Dresden / Schützenhöhe 16
      • Sachsen, Dresden / Schützenhöhe 16, Germany, D-01099
        • Novartis Investigative Site
    • München / Mühlbaurstraße 16
      • Bayern, München / Mühlbaurstraße 16, Germany, D-81677
        • Novartis Investigative Site
    • Roßlau / Kühnauer Straße 70 Sachsen- Anhalt
      • Dessau, Roßlau / Kühnauer Straße 70 Sachsen- Anhalt, Germany, D-06846
        • Novartis Investigative Site
  • Guatemala
      • Guatemala City, Guatemala, 01015
        • Novartis Investigative Site
  • Hungary
    • Bartók B U 2-26
      • Debrecen, Bartók B U 2-26, Hungary, 4043
        • Novartis Investigative Site
    • Semmelweis Tér 1.
      • Kistarcsa, Semmelweis Tér 1., Hungary, 2143
        • Novartis Investigative Site
    • Széchenyi U 27-29
      • Eger, Széchenyi U 27-29, Hungary, 3301
        • Novartis Investigative Site
    • Zrínyi U 1
      • Zalaegerszeg, Zrínyi U 1, Hungary, 8900
        • Novartis Investigative Site
  • Poland
      • Poznań, Poland, NA 61- 734
        • Novartis Investigative Site
      • Wrocław, Poland, NA 50-333
        • Novartis Investigative Site
  • Portugal
      • Lisboa, Portugal, 1749-004
        • Novartis Investigative Site
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454047
        • Novartis Investigative Site
      • Moscow, Russian Federation, 115522
        • Novartis Investigative Site
      • Moscow, Russian Federation, 127473
        • Novartis Investigative Site
      • Petrozavodsk, Russian Federation
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 190068
        • Novartis Investigative Site
      • Saint Petersburg, Russian Federation, 193015
        • Novartis Investigative Site
      • Yaroslavl, Russian Federation, 150003
        • Novartis Investigative Site
  • Singapore
      • Singapore, Singapore, 169611
        • Novartis Investigative Site
  • Slovakia
      • Bratislava, Slovakia, N/A 813 69
        • Novartis Investigative Site
      • Košice, Slovakia, N/A 042 66
        • Novartis Investigative Site
      • Nitra, Slovakia, N/A 949 01
        • Novartis Investigative Site
      • Piešťany, Slovakia, N/A 921 12
        • Novartis Investigative Site
      • Trenčín, Slovakia, N/A 911 50
        • Novartis Investigative Site
  • South Africa
    • Gauteng
      • Pretoria, Gauteng, South Africa, 0153
        • Novartis Investigative Site
  • Spain
      • Madrid, Spain, 28046
        • Novartis Investigative Site
  • Taiwan
      • Kaohsiung, Taiwan, 80756
        • Novartis Investigative Site
      • Kaohsiung, Taiwan, 81346
        • Novartis Investigative Site
      • Taichung, Taiwan, 40705
        • Novartis Investigative Site
      • Taipei, Taiwan, 11217
        • Novartis Investigative Site
  • Turkey
    • Bahcellievler
      • Ankara, Bahcellievler, Turkey, 06490
        • Novartis Investigative Site
    • Balcali
      • Adana, Balcali, Turkey, 01330
        • Novartis Investigative Site
    • Inciraltı
      • İzmir, Inciraltı, Turkey, 35340
        • Novartis Investigative Site
    • Merkez
      • Aydın, Merkez, Turkey, 09100
        • Novartis Investigative Site
      • Manisa, Merkez, Turkey, 45010
        • Novartis Investigative Site
    • Sehitkamil
      • Gaziantep, Sehitkamil, Turkey, 27310
        • Novartis Investigative Site
  • United Kingdom
    • Tyne & Wear
      • Jarrow, Tyne & Wear, United Kingdom, NE32 3DT
        • Novartis Investigative Site
  • United States
    • Washington
      • Seattle, Washington, United States, 98101
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who completed the core study CACZ885H2251. A patient is defined as completing the core study if he/she completed the study up to and including the last visit (Visit 9).
  • Patients who have signed a written informed consent before any trial procedure is performed.

Exclusion Criteria:

  • Patients for whom continuation in the extension 1 is not considered appropriate by the treating physician.
  • 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).

  • Female patients who were physiologically capable of becoming pregnant, unless they were:

    • Female patients whose career, lifestyle, or sexual orientation precluded intercourse with a male partner.
    • Female patients whose partners had been sterilized by vasectomy or other means.
    • Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1.
    • Reliable contraception had to be maintained throughout the study and for 2 months after study drug discontinuation.

Other protocol defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: canakinumab
Drug: Canakinumab

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events and Serious Adverse Events
Time Frame: From start of study up to study completion (up to 14 months)
Adverse events (AEs) were defined as any unfavourable 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) hospitalisation, 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
From start of study up to study completion (up to 14 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Difference Change From Baseline in Participant's Gout Pain During First Flare
Time Frame: Baseline and Day 7
Gout pain was assessed using Visual analogue scale (VAS) with a range of 0 to 100 where 0= no pain, 100= unbearable pain. Difference from time of study drug administration (pre-dose) was reported.
Baseline and Day 7
Number of Participants Achieved Patient's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Time Frame: 24 weeks
Patient's global assessment of response to treatment is 5-point Likert scale:1.Excellent, 2.Good, 3.Acceptable, 4.Slight, 5.Poor. Lower the score better the outcome.
24 weeks
Number of Participants Achieved Physician's Global Assessment of Response to Treatment (5-Point Likert Scale) Based on First, Second, Third Gout Flare Category
Time Frame: 24 weeks
Physician's global assessment of response to treatment is 5-point Likert scale:1.Very good, 2.Good, 3.Fair, 4.Poor, 5.Very poor. Lower the score better the outcome.
24 weeks
Number of Participants Reported No Pain, No Swelling, Absent Erythema on Physician's Assessment of Tenderness, Swelling and Erythema in Most Affected Joint During the First Flare in Participants Treated With Canakinumab by Parameter, Visit and Group
Time Frame: 24 weeks
Tenderness was rated on a 0-3 point scale: 0="no pain", 1=patient states that "there is pain", 2=patient states "there is pain and winces", and 3=patient states "there is pain, winces and withdraws" on palpation or passive movement of the most affected joint. Swelling was rated on a 0-3 point scale: 0="no swelling", 1="palpable", 2="visible", and 3=bulging beyond the joint margins". Erythema was rated as present, absent, or not assessable. Assessments were performed at the flare and control visits.
24 weeks
Amount of Rescue Medication After Study Drug Intake in Participants Treated With Canakinumab by Flare Order, Medication and Group
Time Frame: 24 weeks
The amount of naproxen and prednisolone taken after receiving treatment for each of the first 3 flares was recorded.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 4, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 4, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2009

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 2, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CACZ885H2251E1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings