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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: June 19, 2017
Last verified: June 2017
October 12, 2011
June 19, 2017
November 2011
June 2013   (Final data collection date for primary outcome measure)
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to Day 392 (Week 56) ]
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. TEAEs were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to and including 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Summary of TEAEs (Treatment-Emergent Adverse Events) [ Time Frame: day 1 to week 56 ]
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
Complete list of historical versions of study NCT01459796 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24) [ Time Frame: Day 1 to Day 168 (Week 24) ]
    Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure.
  • Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24) [ Time Frame: Day 1 to Day 168 (Week 24) ]
    Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure.
  • Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52) [ Time Frame: Day 1 to Day 364 (Week 52) ]
    Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain; and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least one gout flare at Week 52 was to be reported for this outcome measure.
  • Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52) [ Time Frame: Day 1 to Day 364 (Week 52) ]
    Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain, and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure.
  • Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52) [ Time Frame: Day 1 to Day 364 (Week 52) ]
    Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated.
  • • Proportion of patients with 1 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ]
  • • Proportion of patients with 1 or more gout flares from day 1 to wk 52 [ Time Frame: day 1 to week 52 ]
  • • Proportion of patients with 2 or more gout flares from day 1 to wk 52. [ Time Frame: day 1 to week 52 ]
  • • Proportion of patients with 2 or more gout flares from day 1 to week 24 [ Time Frame: day 1 to week 24 ]
Not Provided
Not Provided
 
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
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
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Gout
  • Drug: Rilonacept
    Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
  • Drug: Placebo
    Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.
  • Drug: Allopurinol
    Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
  • Experimental: Placebo
    Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 51.
    Interventions:
    • Drug: Placebo
    • Drug: Allopurinol
  • Experimental: Rilonacept 80 mg
    Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 51.
    Interventions:
    • Drug: Rilonacept
    • Drug: Allopurinol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
220
June 2013
June 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Key Inclusion criteria:

  • Male or female participants 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;
  • Participants requiring dialysis;
  • Participants who had 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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01459796
IL1T-GA-1101
Yes
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
June 2017

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