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

• Conditions: Gout flare; MedDRA version: 9.1Level: LLTClassification code 10064900Term: Gout flare

• Registration Number: EUCTR2008-007762-39-DE
• Lead Sponsor: Regeneron Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1.Male or female 18 - 80 years of age
2.Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification of the acute arthritis of primary gout (if any 6 or more of the 13 criteria are present, serially or simultaneously, during any interval of observation) or monosodium urate monohydrate microcrystals have been identified in joint fluid
3.Serum uric acid = 7.5 mg/dL at screening and, according to treating physician or investigator, the subject is a candidate for and does not have any contraindication to treatment with allopurinol
4.A self-reported history of = 2 gout flares in the year prior to the Screening Visit
5.For men and women of childbearing potential, willingness to utilize adequate contraception and not become pregnant (or have their partner[s] become pregnant) during the full course of the study. Adequate contraceptive measures include oral contraceptives (stable use for 2 or more cycles prior to screening) and other prescription pharmaceutical contraceptives; IUD; bilateral tubal ligation; vasectomy; condom or diaphragm plus either contraceptive sponge, foam or jelly
6.Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures
7.Able to read, understand and willing to sign the informed consent form
8.Able to read, understand, and complete study-related questionnaires and diary

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subjects with acute gout flare in the 2 weeks prior to the Screening Visit or during Screening
2.Are pregnant, nursing, or planning a pregnancy or fathering a child within 3 months after receiving the last administration of study drug
3.Have a known or suspected current active infection or a history of chronic or recurrent infectious disease including but not limited to chronic renal infection, chronic chest infection, sinusitis, recurrent urinary tract infection, an open, draining, infected skin wound
4.Within 2 months of first study drug administration, have had a serious infection, have been hospitalized for an infection, have been treated with PO antibiotics for greater than 2 weeks, or have been treated with IV antibiotics for an infection
5.Subjects with chronic active gouty arthritis
6.Evidence of prior or current infection in any affected joint
7.Subjects with a history of inadequate urate-lowering response to
allopurinol or history of allergic reaction, contraindication, or
intolerance to allopurinol
8.Uncontrolled diabetes, defined as HbA1c = 9.0% at the Screening Visit
9.Subjects requiring dialysis
10.Subjects who have had an organ transplant
11.Treatment with any systemic immunosuppresants (e.g. methotrexate, azathioprine, cyclosporine, mercaptopurine, mycophenolate mofetil, tacrolimus, sirolimus, leflunomide, etanercept, adalimumab, infliximab, abatacept, natalizumab, rituximab) within 6 months prior to Baseline Visit; anakinra within 30 days of Baseline Visit
12.Treatment with pegloticase within 6 months of Baseline Visit
13.History of a demyelinating disease or symptoms suggestive of multiple sclerosis
14.Use of oral, intraarticular (IA), intramuscular (IM) or intravenous (IV) glucocorticoids in the 4 weeks prior to the Screening Visit
15.Use of colchicine within 1 month prior to the Screening Visit
16.Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the Screening Visit
17.Treatment with a live (attenuated) virus vaccine during the 3 months prior to Screening Visit
18.Estimated glomerular filtration rate (eGFR) < 30 mL/min
19.Screening Laboratory test results meeting any of the following criteria:
•Hemoglobin (Hgb) < 8.5 g/dL;
•White blood cell (WBC) count < 3.0 x 103/µL ;
•Neutrophil count < 1.5 x 103/µL
•Platelet count < 100 x 103/µL ;
•Total bilirubin exceeding 1.5 times the upper limit of normal unless consistent with Gilbert's syndrome;
•AST/ALT > 2.0 x ULN [Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 2 times the upper limit of normal]
20.For sites in South Africa: HIV antibody positive
For sites in all other countries: History of HIV by clinical or
serological history
21.Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCV) by serologic testing
22.Chest radiograph (or historic results within 3 months of
Screening Visit) that shows evidence of malignancy or any
abnormalities suggestive of prior tuberculosis infection,
including, but not limited to, apical scarring, apical fibrosis, or
multiple calcified granulomata. This does not include
non-caseating granulomata
23.TB criteria:
•History of active TB prior to screening
•Signs or symptoms suggestive of active TB (e.g. new cough of > 14 days in duration or a change in chronic cough, persistent fever, unintentional weight loss, night sweats) upon review of medical history and/or physical examination
•Have recent close contact with a person with active T

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified