Clinical trial NCT00958438: PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
Official title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gout
Keywords: Intercritical Gout
Metabolism, Inborn Errors
Allopurinol
Metabolic Diseases
Genetic Diseases, Inborn
Musculoskeletal Diseases
Joint Diseases
Arthritis
Rheumatic Diseases
Metabolic disorder
Purine-Pyrimidine Metabolism, Inborn Errors
Gout
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-08-13
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 to 80 years of age;
* Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification of the acute arthritis of primary gout;
* At least 2 gout flares in the year prior to the screening visit;
* Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit.

Exclusion Criteria:

* Acute gout flare within 2 weeks of the screening visit or during screening;
* Persistent chronic or active infections;
* History of an allergic reaction to allopurinol;
* History or presence of cancer within 5 years of the screening visit;
* Previous exposure to Rilonacept;
* Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.

Primary outcomes:
measure: Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)
timeFrame: Day 1 to Day 113 (Week 16)
Secondary outcomes:
measure: Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)
timeFrame: Day 1 to Day 113 (Week 16)
measure: Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)
timeFrame: Day 1 to Day 113 (Week 16)
measure: Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)
timeFrame: Day 1 to Day 113 (Week 16)
measure: Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)
timeFrame: Day 1 to Day 113 (Week 16)
measure: Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 113 (Week 16)
timeFrame: Day 1 to Day 113 (Week 16)
Other outcomes:
Locations:
city: Berlin
country: Germany
city: Essen
country: Germany
city: Goch
country: Germany
city: Hamburg
country: Germany
city: Kassel
country: Germany
city: Kuenzing
country: Germany
city: Lollar
country: Germany
city: Magdeburg
country: Germany
city: Muenchen
country: Germany
city: Rhaunen
country: Germany
city: Siegen
country: Germany
city: Ahmedabad
country: India
city: Bangalore
country: India
city: Gandhinagar
country: India
city: Hyderabaad
country: India
city: Kolkatta
country: India
city: Mangalore
country: India
city: Pune
country: India
city: Secunderabad
country: India
city: Vadodara
country: India
city: Varanasi
country: India
city: Denpasar
country: Indonesia
city: Jakarta
country: Indonesia
city: Kemerdekaan
country: Indonesia
city: Palembang
country: Indonesia
city: Semarang
country: Indonesia
city: South Sulawesi
country: Indonesia
city: West Java
country: Indonesia
city: Yogyakarta
country: Indonesia
city: Amanzimtoti
country: South Africa
city: Benoni
country: South Africa
city: Bloemfontein
country: South Africa
city: Breyton
country: South Africa
city: Cape Town
country: South Africa
city: Dundee
country: South Africa
city: Durban North
country: South Africa
city: Durban
country: South Africa
city: Gauteng
country: South Africa
city: Johannesburg
country: South Africa
city: Kempton Park
country: South Africa
city: Krugersdorp
country: South Africa
city: KZ-Natal
country: South Africa
city: Lenasia
country: South Africa
city: Lyttleton
country: South Africa
city: Middleburg
country: South Africa
city: Port Elizabeth
country: South Africa
city: Pretoria
country: South Africa
city: Roodepoort
country: South Africa
city: Scottburgh
country: South Africa
city: Somerset West
country: South Africa
city: Soweto
country: South Africa
city: Worcester
country: South Africa
city: Yungkang City
country: Taiwan
state: Tainan
city: Changhua
country: Taiwan
city: Dalin Town
country: Taiwan
city: Hualien
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Kwei-Shan
country: Taiwan
city: Taichung
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Robert Evans, PharmD
role: STUDY_DIRECTOR
References:
citation: Mitha E, Schumacher HR, Fouche L, Luo SF, Weinstein SP, Yancopoulos GD, Wang J, King-Davis S, Evans RR. Rilonacept for gout flare prevention during initiation of uric acid-lowering therapy: results from the PRESURGE-2 international, phase 3, randomized, placebo-controlled trial. Rheumatology (Oxford). 2013 Jul;52(7):1285-92. doi: 10.1093/rheumatology/ket114. Epub 2013 Mar 13.