NCT00663169

Brief Summary

This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_2

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 22, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

January 7, 2013

Completed
Last Updated

January 7, 2013

Status Verified

December 1, 2012

Enrollment Period

1.5 years

First QC Date

April 18, 2008

Results QC Date

August 30, 2012

Last Update Submit

December 4, 2012

Conditions

Arthritis, Gouty

Keywords

Arthritis GoutyACZ885IL1B proteinPain

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale

    72 hours following treatment, patients were asked the question: "How would you rate the improvement in your gout since receiving the study medication?" Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a "good" or "excellent" response.

    72 hours

Secondary Outcomes (9)

  • Non-inferiority of a Single Dose of Canakinumab Compared to Dexamethasone During Treatment Period

    72 hours

  • Time to Recurrence of the Symptoms of Acute Gout (if Applicable) During Treatment Period

    4 months

  • Time to Walk Independently (if Applicable) During Treatment Period

    4 months

  • Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study

    4 months

  • Change in C-reactive Protein (CRP) From Baseline at Month 4

    Baseline, Month 4

  • +4 more secondary outcomes

Study Arms (2)

Canakinumab

EXPERIMENTAL

Canakinumab 10 mg/kg intravenous infusion and placebo matching dexamethasone intravenous infusion on Day 1.

Biological: canakinumabOther: placebo matching dexamethasone

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 12 mg intravenous infusion and placebo matching canakinumab on Day 1.

Drug: dexamethasoneOther: placebo matching canakinumab

Interventions

canakinumabBIOLOGICAL

10 mg/kg intravenous infusion 250 mL over 2 hours.

Also known as: ACZ885, Ilaris®
Canakinumab
dexamethasoneDRUG

12 mg intravenous infusion 50 mL over 30 minutes.

Dexamethasone
placebo matching canakinumabOTHER

5% glucose in water intravenous infusion.

Dexamethasone
placebo matching dexamethasoneOTHER

Placebo intravenous infusion.

Canakinumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • score over 50 on the 0-100 VAS pain scale
  • acute, confirmed gout flare for no longer than 3 days

You may not qualify if:

  • Treatment with biological anti-tumor necrosis factor (anti-TNF) within the past 3 months
  • Anti-inflammatory medication for the treatment of acute gout within the previous 24 hours
  • Pregnant or breastfeeding women
  • Major surgery with high infection risk
  • History of severe allergy to food or drugs
  • History or risk of tuberculosis
  • Active infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigator Site

Birmingham, Alabama, 35249, United States

Location

Novartis Investigator Site

New Brunswick, New Jersey, 08901, United States

Location

Novartis Investigator Site

Lausanne, Switzerland

Location

Novartis Investigator Site

Glasgow, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, GoutyPain

Interventions

canakinumabDexamethasone

Condition Hierarchy (Ancestors)

GoutArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
862-778-8300

Study Officials

  • Novartis

    Novartis investigator site

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 18, 2008

First Posted

April 22, 2008

Study Start

April 1, 2008

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 7, 2013

Results First Posted

January 7, 2013

Record last verified: 2012-12

Locations

CH(1)US(2)GB(1)