Canakinumab in the Treatment of Gouty Arthritis Flare(s) and Prevention of New Flares in Patients With Chronic Kidney Disease

NCT01593527 | Withdrawn Phase 3

• 2 other identifiers: CACZ885H24022011-001766-18
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to confirm the efficacy and safety results obtained in a chronic kidney disease (CKD) subgroup of patients participating in Phase III studies in a larger, independent patient population with difficult to treat gouty arthritis and moderate to severe CKD (stage 3 - 4).

Conditions

Acute Gouty Arthritis

Keywords

Frequent flares; Frequent attacks; gout; gouty arthritis; Chronic kidney disease; renal impairment; Anti-interleukin-1β monoclonal antibody; anti-inflammatory therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing

  12 Weeks

Secondary Outcomes (5)

• The time to the first new gout flare

  12 Weeks

• Score on Visual Analog Scale at 72 hours to measure gouty arthritis pain intensity and resolution

  12 weeks

• Number of patients needing rescue medication use during acute gouty arthritis flare(s)

  12 Weeks

• Measurement of efficacy using inflammatory markers

  12 Weeks

• Time to 50% reduction of baseline pain intensity in the most affected joint

  12 weeks

Study Arms (2)

Arm 1

EXPERIMENTAL

Canakinumab 150 mg s.c.

Drug: ACZ885

Arm 2

EXPERIMENTAL

Triamcinelone acetonide 40 mg i.m.

Drug: Triamcinelone acetonide

Interventions

ACZ885 DRUG

Canakinumab 150 mg s.c.

Arm 1

Triamcinelone acetonide DRUG

Triamcinelone acetonide 40 mg i.m.

Arm 2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of gouty arthritis History of ≥ 3 gouty arthritis flares within the previous 12 months
• Confirmed diagnosis/ documented history of chronic kidney disease (CKD) Stages 3or4
• Onset of current acute gouty arthritis flare within 3 days prior to randomization

You may not qualify if:

• Hemodialysis CKD Stage 5 Organ transplantation
• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Gout; Arthritis, Gouty; Renal Insufficiency, Chronic; Renal Insufficiency

Interventions

canakinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 8, 2012
• Study Start: September 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 20, 2017

Record last verified: 2013-08