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

Novartis

Status and phase: Completed; Phase 3

Conditions: Acute Gouty Arthritis

Treatments: Drug: Canakinumab lyophilized powder; Drug: Triamcinolone Acetonide; Drug: Canakinumab pre-filled syringe; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01356602

CACZ885H2361

2010-024173-39 (EudraCT Number)

Details and patient eligibility

About

This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Enrollment: 397 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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397 participants in 3 patient groups

Canakinumab, pre-filled syringes (PFS)

Experimental group

Description:

Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.

Treatment:

Drug: Canakinumab pre-filled syringe

Drug: Placebo

Canakinumab, lyophilizate (LYO)

Active Comparator group

Description:

The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.

Treatment:

Drug: Placebo

Drug: Canakinumab lyophilized powder

Triamcinolone Acetonide

Active Comparator group

Description:

The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.

Treatment:

Drug: Triamcinolone Acetonide

Drug: Placebo