An adaptive dose-ranging, multi-center, single-blind, double-dummy, active-controlled trial to determine the target dose of canakinumab (ACZ885) in the treatment of acute flares in gout patients who are refractory or contraindicated to NSAIDs and/or colchicine - H2255

• Conditions: Acute gout (patients who are refractory or contraindicated to NSAIDs and/or colchicine); MedDRA version: 9.1Level: LLTClassification code 10018628Term: Gout acute

• Registration Number: EUCTR2008-004666-61-DE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Signed written informed consent before any study procedure is performed.
Male or female patients aged = 18 - = 80 years.

History of at least 1 gout flare prior to the Screening Visit (based on patient history).
Meeting the 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 = 50 mm on the 0-100 mm VAS.

Refractory (previous unsatisfactory outcome) to NSAID and/or colchicine use
OR
Absolutely or relatively contraindicated (e.g. due to co-morbidities such as kidney insufficiency, type 2 diabetes, gastrointestinal intolerance or other reasons) to NSAID and/or colchicine use.

Patients on urate lowering therapy (e.g. allopurinol, probenecid) or on prophylactic colchicine must be on a stable dose and schedule with no changes in therapy for 4 weeks prior to randomization and expected to remain on a stable regimen during study participation.

Patients with a BMI = 40 kg/m2.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Ibuprofen within 4 hours before screening (Day 1) or > 400 mg within 8 hours before screening.

Paracetamol within 4 hours before screening or > 1 g within 24 hours before screening.

Aspirin within 4 hours before screening or > 600 mg within 24 hours before screening.

Aspirin- or paracetamol-based combination medications: any number of tablets within 4 hours before screening or > 2 tablets within 24 hours before screening.

Diclofenac within 8 hours before screening or > 50 mg within 24 hours before screening.

Naproxen within 12 hours before screening or > 500 mg within 24 hours before screening.

Cox-2 inhibitors within 48 hours before screening.

NSAIDs within 24 hours before screening.

Systemic corticosteroids within 24 hours before screening (dose < 10 mg of prednisolone or equivalent is permissible within 24 hours before screening).

I.A. corticosteroids within 4 weeks before screening.

More than 1 single dose of 0.6 mg colchicine within 24 hours before screening, if not on stable dose and regimen.

Anakinra therapy within 24 hours before screening.

Rilonacept within 1 week before screening.

Investigational medicinal products other than anakinra or rilonacept, within 30 days (or 3 months for mAbs) or 5 half-lives before screening, whichever is longer or instructed by local regulations.

TNF inhibitors within the past 3 months prior to randomization

Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis.

Severe renal function impairment. History of renal trauma, glomerulonephritis, patients with one kidney, or renal failure requiring regular dialysis treatments.

History of clinically significant drug allergy. History of hypersensitivity to the study drug or to molecules with similar structures.

Presence of idiopathic thrombocytopenic purpura.

Contraindication to intramuscular injection.

Donation or loss of 400 mL or more of blood in the 8 weeks before dosing.

Live vaccinations within 3 months prior to the start of the study. Killed or inactivated vaccines may be permitted according to the investigator’s discretion.

Known presence or suspicion of active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of HIV infection, Hep B and Hep C infections.

Evidence of active pulmonary disease (e.g. tuberculosis, fungal diseases).

Requirement for administration of antibiotics against latent TB, e.g., isoniazide.

One of the risk factors for TB such as:

History of any of the following: residence in a congregate setting, substance abuse, health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient, or close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period) with a person with active pulmonary TB disease.

Any surgical or underlying hepatic, hematologic, pulmonary, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/or places the patient at unacceptable risk for participation in an immunodulatory therapy.

Long QT syndrome or QTc > 450 msec for males and > 470 msec for females at screening or baseline.

Significant medical problems, including but not limited to the following: uncontrolled hypertension (= 200/105 mmHg), CHF [NYHA IV], uncontrolled diabetes type I and II (

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified