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

Phase 3

Terminated

• Conditions: Gouty Arthritis
• Interventions: Drug: Canakinumab, ACZ885; Drug: Triamcinolone acetonide

• Registration Number: NCT01362608
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-05-24
• Study First Submitted QC: 2011-05-26
• Study First Posted: 2011-05-30
• Study Start: 2011-06-20
• Primary Completion: 2015-05-19
• Study Completion: 2015-05-19
• Results First Submitted: 2016-05-19
• Status Verified: 2017-06
• Results First Submitted QC: 2017-06-07
• Last Update Submitted: 2017-06-07
• Results First Posted: 2017-06-08
• Last Update Posted: 2017-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Canakinumab and placebo matching to triamcinolone acetonide	Canakinumab, ACZ885	ACZ885H
Triamcinolone acetonide 40 mg	Triamcinolone acetonide	ACZ885H

Primary Outcome Measures

Name	Time	Method
The Change in the Gout Pain Intensity in the Target Joint Following ACZ885 Administration Measured by Visual Analog Scale (VAS)	at 72 hours post-dose	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)
Time to First New Flare: Survival Analysis by Treatment: Kaplan Meier Analysis	12 weeks	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

Secondary Outcome Measures

Name	Time	Method
Patient's Assessment of Gout Pain Intensity in the Most Affected Joint (Likert Scale): Frequency Table by Timepoint and Treatment	baseline through week 12	Patients will score their current pain intensity in the most affected joint of the gout flare on a 5-point Likert scale (none, mild, moderate, severe, extreme).
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	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)
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	Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Time to at Least a 50% Reduction in Baseline Pain Intensity: Survival Analysis by Treatment	12 weeks	Kaplan Meier estimate
Time to First Rescue Medication Intake	12 weeks
Percent Patients Who Took Rescue Medication	12 weeks
Amount of Rescue Medication Taken at Baseline Flare and Post Baseline Flare.	12 weeks	Paracetamol / acetaminophen, Prednisolone and Prednisone taken at baseline flare and post baseline flare.
High Sensitivity C-reactive Protein [hsCRP] Measured in the Serum at 72 Hours Post Dose	72 hours post dose
Physician's Assessment of Swelling: Frequency Table by Timepoint and Treatment	baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose	Physicians will score their response to pain on a 5-point Likert scale (no pain, pain,pain and winces,pain winces and withdraws and not assessed).
Patient's Global Assessment of Response to Treatment: Frequency Table by Timepoint and Treatment Using a Likert Scale.	72 hours through week 12	Patients will score their response to pain on a 7-point Likert scale (excellent, good ,acceptable, slight,poor,very poor,not done).
Physician's Assessment of Erythema: Frequency Table by Timepoint and Treatment	baseline 72 hours,7 days 4 weeks, 8 weeks and 12 weeks post dose	Physicians will score their response of erythema on a 4-point Likert scale (absent, present not assessed and not assessable).
Physician's Assessment of Range of Motion: Frequency Table by Timepoint and Treatment	baseline through week 12	Physicians will score their response ofrange of motion on a 5-point Likert scale (normal,mildly restricted, moderately restricted, severely restricted and immolbilized).
Time to Complete Resolution of Pain: Survival Analysis by Treatment	12 weeks	Kaplan Meier estimate

Trial Locations

Locations (1)

Novartis Investigative Site; 🇸🇬 Singapore, Singapore