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β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)

NCT01470989 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2021-07-09

Study results available
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Summary

This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.

Conditions

  • Acute Gouty Arthritis Flares

Interventions

DRUG

ACZ885

canakinumab 150 mg s.c., given on demand upon new flares

DRUG

Triamcinolone acetonide 40 mg

Participants received 40 mg intramuscular (IM)

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • United States
  • Australia
  • Canada
  • Estonia
  • Germany
  • Latvia
  • Lithuania
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01470989 on ClinicalTrials.gov