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

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ClinicalTrials.gov Identifier: NCT01459796
Recruitment Status : Terminated
First Posted : October 26, 2011
Results First Posted : July 18, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 12, 2011
First Posted Date  ICMJE October 26, 2011
Results First Submitted Date  ICMJE April 23, 2017
Results First Posted Date  ICMJE July 18, 2017
Last Update Posted Date July 18, 2017
Study Start Date  ICMJE November 2011
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
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
Change History Complete list of historical versions of study NCT01459796 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
  • • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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 was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Gout
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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
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
Actual Enrollment  ICMJE
 (submitted: June 19, 2017)
220
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2011)
350
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01459796
Other Study ID Numbers  ICMJE IL1T-GA-1101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Regeneron Pharmaceuticals
Study Sponsor  ICMJE Regeneron Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
PRS Account Regeneron Pharmaceuticals
Verification Date June 2017

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