Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective

NCT01362608 | Terminated Phase 3 Results

• 2 other identifiers: CACZ885H23582010-024172-26
• Study Type: interventional
• Target: 136
• Locations: 4 countries
• Sites: 20

Brief Summary

The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent flares of gout for whom NSAIDs and/or colchicine are contraindicated, not tolerated or ineffective, canakinumab 150 mg s.c. given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares compared to triamcinolone acetonide 40 mg i.m.

Conditions

Gouty Arthritis

Keywords

Gout; Inflammatory gout; acute gout

Outcome Measures

Primary Outcomes (2)

• The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)

  A higher score indicates greater pain intensity. Based on the distribution of pain VAS scores in postsurgical patients (knee replacement, hysterectomy, or laparoscopic myomectomy) who described their postoperative pain intensity as none, mild, moderate, or severe, the following cut points on the pain VAS have been recommended: no pain (0 - 4 mm), mild pain (5- 44 mm), moderate pain (45-74 mm), and severe pain (75- 100 mm)

  at 72 hours post-dose

• Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis

  Measure canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to the time to the first new gout flare in observation period of 12 weeks

  12 weeks

Secondary Outcomes (14)

• The Number of Patients With at Least 1 New Gout Flare

  12 weeks

• Patients Assessment of Gout Pain Intensity in the Most Effected Joint (0-100mm VAS): Summary Statistics by Timepoint and Treatment

  baseline through 12 weeks

• Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment

  baseline through week 12

• Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.

  72 hours through week 12

• Physician's Assessment of Tenderness: Frequency Table by Timepoint and Treatment

  baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose

Study Arms (2)

Canakinumab and placebo matching to triamcinolone acetonide

EXPERIMENTAL

ACZ885H

Drug: Canakinumab, ACZ885

Triamcinolone acetonide 40 mg

ACTIVE COMPARATOR

ACZ885H

Drug: Triamcinolone acetonide

Interventions

Canakinumab, ACZ885 DRUG

Canakinumab and placebo matching to triamcinolone acetonide

Canakinumab and placebo matching to triamcinolone acetonide

Triamcinolone acetonide DRUG

Triamcinolone acetonide 40 mg and placebo matching to canakinumab

Triamcinolone acetonide 40 mg

Eligibility Criteria

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

You may qualify if:

• Meeting diagnosis criteria for acute arthritis of primary gout.
• Start of acute gout flare within 5 days prior to study visit 1
• History of ≥ 3 gout flares within the 12 months prior to study start
• Evidence of contraindication (absolute or relative), or intolerance, or lack of efficacy for either NSAIDs and/or colchicines

You may not qualify if:

• Requirement for administration of antibiotics against latent tuberculosis (TB), e.g., isoniazide
• Refractory heart failure (Stage D).
• Unstable cardiac arrhythmias or unstable symptomatic coronary ischemia
• Secondary gout, chemotherapy induced gout, lead induced gout and transplant gout
• Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (20)

Novartis Investigative Site

Ciudad Autonoma de Bs As, C1015ABO, Argentina

Location

Novartis Investigative Site

Hefei, Anhui, 230001, China

Location

Novartis Investigative Site

Hefei, Anhui, 230022, China

Location

Novartis Investigative Site

Beijing, Beijing Municipality, 100730, China

Location

Novartis Investigative Site

Guangzhou, Guangdong, 510080, China

Location

Novartis Investigative Site

Nanjing, Jiangsu, 210029, China

Location

Novartis Investigative Site

Xi’an, Shanxi, 710032, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

Novartis Investigative Site

Chengdu, Sichuan, 610072, China

Location

Novartis Investigative Site

Hangzhou, Zhejiang, 310009, China

Location

Novartis Investigative Site

Beijing, 100029, China

Location

Novartis Investigative Site

Beijing, 100044, China

Location

Novartis Investigative Site

Shanghai, 200127, China

Location

Novartis Investigative Site

Shanghai, 200433, China

Location

Novartis Investigative Site

Wuhan, 430022, China

Location

Novartis Investigative Site

Katowice, 40-084, Poland

Location

Novartis Investigative Site

Poznan, 60-773, Poland

Location

Novartis Investigative Site

Wroclaw, 50-349, Poland

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Arthritis, Gouty; Gout

Interventions

canakinumab; Triamcinolone Acetonide

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

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Limitations and Caveats

This study was terminated early. The decision to terminate study was not out of concerns for efficacy or safety of canakinumab

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: May 24, 2011
• First Posted: May 30, 2011
• Study Start: June 20, 2011
• Primary Completion: May 19, 2015
• Study Completion: May 19, 2015
• Last Updated: June 8, 2017
• Results First Posted: June 8, 2017

Record last verified: 2017-06

Locations

AR (1); PL (3); CN (14); SG (2)