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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
  Purpose
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.

Condition Intervention Phase
Gout Drug: Rilonacept Drug: Placebo Drug: Allopurinol Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 220
Study Start Date: November 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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: 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.
Drug: Rilonacept
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
Drug: Allopurinol
Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459796

  Show 74 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01459796     History of Changes
Other Study ID Numbers: IL1T-GA-1101
Study First Received: October 12, 2011
Results First Received: April 23, 2017
Last Updated: June 19, 2017

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 17, 2017