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

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ClinicalTrials.gov Identifier: NCT01431638
Recruitment Status : Completed
First Posted : September 9, 2011
Results First Posted : July 19, 2021
Last Update Posted : July 19, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Gouty Arthritis Drug: Canakinumab 150mg in prefilled syringe Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 397 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Uncontrolled
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 25, 2011
Actual Primary Completion Date : May 9, 2013
Actual Study Completion Date : May 9, 2013

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Arthritis
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: Canakinumab 150mg
Canakinumab 150mg in prefilled syringe subcutaneously
Drug: Canakinumab 150mg in prefilled syringe
Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. Probability of New Gout Flares at End of Study [ Time Frame: Up to Day 337 ]
    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.

  2. Number of Participant With New Flares [ Time Frame: up to 36 weeks ]
    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.

  3. Change From Baseline in Pain Intensity on a 5-point Likert Scale [ Time Frame: Baseline, upto 14 days post-dose ]
    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.

  4. Change From Baseline in Pain Intensity in the Most Affected Joint (on a 0-100 mm Visual Analogue Scale [VAS]) Over Time [ Time Frame: Baseline, 6, 12, 24, 48, 72 hours post-dose, and Day 4 - 14 post-dose ]
    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.

  5. Number of Participants Who Responded for Patient's Global Assessment of Response to Treatment [ Time Frame: 48 weeks post-dose ]
    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).

  6. Number of Participants Responded for Physician's Assessment of Tenderness, Swelling and Erythema of the Most Affected Joint [ Time Frame: Baseline, 7 days post-dose ]
    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.

  7. Number of Participants Responded for Physician's Global Assessment of Response to Treatment [ Time Frame: 7 days post-dose ]
    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.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

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

Exclusion criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431638


Locations
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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01431638    
Other Study ID Numbers: CACZ885H2361E1
2011-001342-15
First Posted: September 9, 2011    Key Record Dates
Results First Posted: July 19, 2021
Last Update Posted: July 19, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Gout
arthritis
gout flare
acute gout
gouty
rheumatic disease
uric acid
podagra
Additional relevant MeSH terms:
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Gout
Arthritis
Arthritis, Gouty
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases