Canakinumab in the Treatment of Gouty Arthritis Flare(s)... | NCT01593527

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

NCT01593527

Sponsor

Novartis Pharmaceuticals

Status

Withdrawn

Last Update Posted

Apr 20, 2017Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Acute Gouty Arthritis

Interventions

ACZ885
Triamcinelone acetonide

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011-001766-18	EudraCT Number

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Sep 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

May 3, 2012

First Submission Date that Met QC Criteria

May 4, 2012

First Posted Date

May 8, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2017

Last Update Posted Date

Apr 20, 2017Actual

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	Canakinumab 150 mg s.c.	Drug: ACZ885
Arm 2	Experimental	Triamcinelone acetonide 40 mg i.m.	Drug: Triamcinelone acetonide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACZ885	Drug	Canakinumab 150 mg s.c.	Arm 1
Triamcinelone acetonide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of patients experiencing new gouty arthritis flares during 12-week follow-up from dosing		12 Weeks

Secondary Outcomes

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

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

Exclusion criteria:

Hemodialysis CKD Stage 5 Organ transplantation
Rheumatoid arthritis, evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis
Live vaccinations within 3 months prior to randomization Other protocol-defined inclusion/exclusion criteria may apply

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006073	Gout
D015210	Arthritis, Gouty
D051436	Renal Insufficiency, Chronic
D051437	Renal Insufficiency

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D000070657	Crystal Arthropathies

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C541220	canakinumab

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided