Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares (UPSURGE)

This study has been terminated.

Sponsor:

Information provided by (Responsible Party):

Regeneron Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01459796

First received: October 12, 2011

Last updated: November 12, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2011

Last Updated Date

November 12, 2012

Start Date ^ICMJE

November 2011

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Summary of TEAEs (Treatment-Emergent Adverse Events) [ Time Frame: day 1 to week 56 ] [ Designated as safety issue: Yes ]

Safety as assessed by summarizing the incidences and types of treatment-emergent adverse events (TEAEs) and changes in laboratory parameters from day 1 to wk 56

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01459796 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of patients with 1 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ] [ Designated as safety issue: No ]
Proportion of patients with 1 or more gout flares from day 1 to wk 52 [ Time Frame: day 1 to week 52 ] [ Designated as safety issue: No ]
Proportion of patients with 2 or more gout flares from day 1 to wk 52. [ Time Frame: day 1 to week 52 ] [ Designated as safety issue: No ]
Proportion of patients with 2 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

• Proportion of patients with 1 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ] [ Designated as safety issue: No ]
• Proportion of patients with 1 or more gout flares from day 1 to wk 52 [ Time Frame: day 1 to week 52 ] [ Designated as safety issue: No ]
• Proportion of patients with 2 or more gout flares from day 1 to wk 52. [ Time Frame: day 1 to week 52 ] [ Designated as safety issue: No ]
• Proportion of patients with 2 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Official Title ^ICMJE

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Brief Summary

The purpose of this study is to determine the safety and tolerability of rilonacept for patients with gout who are initiating allopurinol.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Gout

Intervention ^ICMJE

Drug: Rilonacept
Regimen 1
Drug: Placebo
Regimen 2
Drug: Allopurinol
Background Treatment

Study Arm (s)

Active Comparator: Group 1
Interventions:
- Drug: Rilonacept
- Drug: Allopurinol
Placebo Comparator: Group 2
Interventions:
- Drug: Placebo
- Drug: Allopurinol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

219

Estimated Completion Date

June 2013

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Key Inclusion criteria:

Male or female patients aged 18 to 80 years
Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout
Serum uric acid greater than or equal to 7.5 mg/dL at the Screening Visit
A self-reported history of at least 2 gout flares in the year prior to screening

Exclusion Criteria:

Key Exclusion criteria:

Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug
Patients requiring dialysis
Patients who have had an organ transplant
Persistent chronic or active infections
Previous exposure to rilonacept
Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the Screening Visit

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01459796

Other Study ID Numbers ^ICMJE

IL1T-GA-1101

Has Data Monitoring Committee

Yes

Responsible Party

Regeneron Pharmaceuticals

Study Sponsor ^ICMJE

Regeneron Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trial Management

Regeneron Pharmaceuticals

Information Provided By

Regeneron Pharmaceuticals

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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