Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Acute Gout

Treatments: Drug: Triamcinolone acetonide; Drug: Canakinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00798369

EudraCT 2008-004666-61

CACZ885H2255

Details and patient eligibility

About

This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the management of acute flare in gout patients who are contraindicated to Non-Steroidal anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the corticosteroid triamcinolone acetonide.

Enrollment: 200 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of at least 1 gout flare prior to the Screening Visit
• Meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout.
• Presence of acute gout flare for no longer than 5 days.
• Baseline pain intensity > or = to 50 mm on the 0-100 mm VAS.
• Contraindicated for, intolerant or unresponsive to NSAIDs, colchicine or both.

Exclusion criteria

• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.
• Presence of severe renal function impairment
• Contraindication to intramuscular injection
• Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment
• Evidence of active pulmonary disease
• Live vaccinations within 3 months prior to the start of the study
• Use of forbidden therapy

Other protocol-defined inclusion/exclusion criteria applied

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

200 participants in 6 patient groups

Canakinumab 10 mg

Experimental group

Description:

Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

Treatment:

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Canakinumab 25 mg

Experimental group

Description:

Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

Treatment:

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Canakinumab 50 mg

Experimental group

Description:

Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

Treatment:

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Canakinumab 90 mg

Experimental group

Description:

Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

Treatment:

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Canakinumab 150 mg

Experimental group

Description:

Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.

Treatment:

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Drug: Canakinumab

Triamcinolone acetonide 40 mg

Active Comparator group

Description:

Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.

Treatment:

Drug: Triamcinolone acetonide