Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01356602
• Date of registration: 16/05/2011
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
• Scientific title: A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients
• Date of first enrolment: May 2011
• Target sample size: 397
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01356602
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Germany, Hungary, Lithuania, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion criteria:

- 3 or more gout flares within last year

- Contraindication, intolerance or lack of efficacy for NSAIDs and/or colchicine

- Body mass index of less than or equal to 45 kg/m2

Exclusion criteria:

- Use of the following therapies (within varying protocol defined timeframes):
corticosteroids, narcotics, topical ice/cold packs, chronic opiate treatment, NSAIDs
(such as aspirin), colchicine.

- Hemodialysis

- Live vaccine within 3 months before first dose

- Donation or loss of 400 mL or more within 3 months before first dose

- Gout brought on by other factors such as chemotherapy, lead, transplant, etc.

- Presence of other acute inflammatory arthritis such as Rheumatoid Arthritis

- Any conditions or significant medical problems that puts the patient at an
unacceptable immunological risk to receive this type of therapy such as HIV,
Hepatitis, Tuberculosis and other infections/conditions

- Significant cardiovascular conditions such as uncontrolled hypertension

- Significant medical diseases such as uncontrolled diabetes, thyroid disease

- History of malignancy of any organ system within the past 5 years

- Women who are pregnant or nursing

- Other protocol-defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Gouty Arthritis

Intervention(s)

Drug: Placebo

Drug: Triamcinolone Acetonide

Drug: Canakinumab lyophilized powder

Drug: Canakinumab pre-filled syringe

Primary Outcome(s)

Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups [Time Frame: 72 hours post dose]

Secondary Outcome(s)

Pain Intensity on a 0 - 100 mm VAS Between the Canakinumab 150 mg PFS and Canakinumab 150 mg LYO Groups [Time Frame: 72 hours post dose]

Time to 50% Reduction in Baseline Pain on a 0 - 100 VAS [Time Frame: 14 days]

Time to the First New Gouty Arthritis Flare [Time Frame: 12 weeks]

C-reactive Protein Level [Time Frame: 72 hours]

Patient's Assessment of Pain Intensity on a 5-point Likert Scale [Time Frame: 72 hours]

Number of Patients With at Least One New Gouty Arthritis Flare After Baseline [Time Frame: 12 weeks]

Patient's Assessment of Pain Intensity on a 0-100mm VAS [Time Frame: 14 days]

Patient's Global Assessment of Response to Treatment on a 5-point Likert Scale [Time Frame: 72 hours]

Time to Resolution of Gouty Arthritis Flare as Reported by Patient [Time Frame: 14 days]

Physician's Assessment of Range of Motion of the Most Affected Joint [Time Frame: 72 hours]

Amount of Rescue Medication Taken (mg) [Time Frame: 14 days]

Physician's Assessment of Swelling [Time Frame: 72 hours]

Physician's Global Assessment of Response to Treatment on a 5 Point Likert Scale [Time Frame: 72 hours]

Proportion of Patients With Rescue Medication Intake [Time Frame: 12 weeks]

Physician's Assessment of Erythema [Time Frame: 72 hours]

Physician's Assessment of Tenderness [Time Frame: 72 hours]

Time to First Rescue Medication Intake [Time Frame: 14 days]

Secondary ID(s)

2010-024173-39

CACZ885H2361

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 29/01/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01356602