Gout flares MedDRA version: 9.1 Level: LLT Classification code 10064900 Term: Gout flare
Conditions
Interventions
Trade Name: ARCALYST™
Product Name: rilonacept
Pharmaceutical Form: Powder for injection*
INN or Proposed INN: rilonacept
CAS Number: 501081-76-1
Current Sponsor code: rilonacept (USAN)
Concentration
Sponsors
Regeneron Pharmaceuticals Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.Subjects with history of gout, initiating or currently on urate lowering therapy who are at risk of gout flare. -Subjects initiating urate lowering therapy at baseline with either allopurinol, probenecid, sulfinpyrazone, or febuxostat OR -Subjects currently on urate lowering therapy with allopurinol, probenecid, sulfinpyrazone, or febuxostat for a period of = 2 months prior to baseline visit. OR -Subjects currently on urate lowering therapy with allopurinol, probenecid, sulfinpyrazone, or febuxostat for longer than 2 months with serum uric acid values at screening/baseline of 7.0 mg/dl or greater OR -Subjects currently on urate lowering therapy with allopurinol, probenecid, sulfinpyrazone, or febuxostat with evidence of tophi, regardless of serum urate level. 4.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 5.Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures 6.Able to read, understand and willing to sign the informed consent form 7.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
Exclusion criteria: 1.Are pregnant, nursing, or planning a pregnancy or fathering a child within 3 months after receiving the last administration of study drug 2.Subjects with acute gout flare in the 2 weeks prior to the Screening Visit or during Screening 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 (for those subjects treated with 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 immunosuppressants (e.g., methotrexate, leflunomide, etanercept, adalimumab, infliximab, abatacept, natalizumab, rituximab, cyclosporine, mycophenolate, tacrolimus, sirolimus, azathiopurine or mercaptopurine) 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 14 days prior to the Screening Visit 16.Treatment with a live (attenuated) virus vaccine during the 3 months prior to screening visit 17.Estimated glomerular filtration rate (eGFR) 2.0 x ULN [Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) exceeding 2 times the upper limit of normal] 19.For sites in South Africa: HIV antibody positive For sites in all other countries: History of HIV by clinical or serological history 20.Hepatitis B surface antigen (HBsAg) and/or Hepatitis C antibody (HCV) by serologic testing 21.A chest radiograph 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. 22.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 TB -History of latent untreated TB 23.For
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the safety and tolerability of 160 mg of subcutaneous (SC) therapy with rilonacept in the prophylaxis of gout flares in subjects on urate lowering therapy. ;Secondary Objective: To assess the efficacy of rilonacept as seen in clinical practice;Primary end point(s): The primary endpoints are safety assessed by summarizing the incidences and types of treatment-emergent adverse events and changes in laboratory parameters. The secondary efficacy endpoints are as following: •The number of gout flares from Day 1 to Week 16 . The proportion of subjects with one or more gout flares from Day 1 to Week 16 •The proportion of subjects with at least two flares from Day 1 to Week 16 •The number of gout flare-days from Day 1 to Week 16 For the purpose of analysis, a gout flare is defined as subject-reported acute articular pain typical a gout attack that is deemed (by the subject and/or the Investigator) to require treatment with an anti-inflammatory medicine. | — |
Countries
Germany
Outcome results
None listed