scholarly journals Rilonacept (Interleukin-1 Trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: Results of a phase II randomized, double-blind, placebo-controlled trial

2012 ◽  
Vol 64 (3) ◽  
pp. 876-884 ◽  
Author(s):  
H. Ralph Schumacher ◽  
John S. Sundy ◽  
Robert Terkeltaub ◽  
Howard R. Knapp ◽  
Scott J. Mellis ◽  
...  
Keyword(s):  
Phase Ii ◽  
Controlled Trial ◽  
Interleukin 1 ◽  
Acute Gout ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Lowering Therapy ◽  
Gout Flares

scholarly journals Feasibility randomised multicentre, double-blind, double-dummy controlled trial of anakinra, an interleukin-1 receptor antagonist versus intramuscular methylprednisolone for acute gout attacks in patients with chronic kidney disease (ASGARD): protocol study

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017121 ◽  
Author(s):  
Gowrie Balasubramaniam ◽  
Trisha Parker ◽  
David Turner ◽  
Mike Parker ◽  
Jonathan Scales ◽  
...  
Keyword(s):  
Chronic Kidney Disease ◽  
Kidney Disease ◽  
Controlled Trial ◽  
Interleukin 1 ◽  
Scale Up ◽  
General Information ◽  
Primary Objective ◽  
Retention Rates ◽  
Acute Gout ◽  
Double Blind

IntroductionAcute gout occurs in people with chronic kidney disease, who are commonly older people with comorbidities such as hypertension, heart disease and diabetes. Potentially harmful treatments are administered to these vulnerable patients due to a lack of clear evidence. Newly available treatment that targets a key inflammatory pathway in acute gout attacks provides an opportunity to undertake the first-ever trial specifically looking treating people with kidney disease. This paper describes the protocol for a feasibility randomised controlled trial (RCT) comparing anakinra, a novel interleukin-1 antagonist versus steroids in people with chronic kidney disease (ASGARD).Methods and analysisASGARD is a two-parallel group double-blind, double-dummy multicentre RCT comparing anakinra 100 mg, an interleukin-1 antagonist, subcutaneous for 5 days against intramuscular methylprednisolone 120 mg. The primary objective is to assess the feasibility of the trial design and procedures for a definitive RCT. The specific aims are: (1) test recruitment and retention rates and willingness to be randomised; (2) test eligibility criteria; (3) collect and analyse outcome data to inform sample and power calculations for a trial of efficacy; (4) collect economic data to inform a future economic evaluation estimating costs of treatment and (5) assess capacity of the project to scale up to a national multicentre trial. We will also gather qualitative insights from participants. It aims to recruit 32 patients with a 1:1 randomisation. Information from this feasibility study will help design a definitive trial and provide general information in designing acute gout studies.Ethics and disseminationThe London-Central Ethics Committee approved the protocol. The results will be disseminated in peer-reviewed journals and at scientific conferences.Trial registration numberEudraCT No. 2015-001787-19, NCT/Clinicalstrials.gov No.NCT02578394, pre-results, WHO Universal Trials Reference No. U1111-1175-1977. NIHR Grant PB-PG-0614–34090.

scholarly journals Anakinra for the treatment of acute gout flares: a randomized, double-blind, placebo-controlled, active-comparator, non-inferiority trial

Rheumatology ◽  
2019 ◽  
Vol 58 (8) ◽  
pp. 1344-1352 ◽  
Author(s):  
Carly A Janssen ◽  
Martijn A H Oude Voshaar ◽  
Harald E Vonkeman ◽  
Tim L Th. A Jansen ◽  
Matthijs Janssen ◽  
...  
Keyword(s):  
Rating Scale ◽  
Analysis Of Covariance ◽  
Acute Gout ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Treatment As Usual ◽  
Double Blind Placebo ◽  
Active Comparator ◽  
Secondary Outcomes ◽  
Gout Flares

AbstractObjectivesTo evaluate the efficacy and safety of anakinra in treating acute gout flares in a randomized, double-blind, placebo-controlled, active comparator, non-inferiority (NI) trial.MethodsPatients with a crystal-proven acute gout flare were randomized (1: 1) to treatment with anakinra or treatment as usual (free choice: either colchicine, naproxen or prednisone). The primary end point was the change in pain between baseline and the averaged pain score on days 2–4 measured on a five-point rating scale. NI of anakinra would be established if the upper bound of the 95% CI of the numeric difference in changed pain scores between treatment groups did not exceed the NI limit of 0.4 in favour of treatment as usual, in the per-protocol (PP) and intention-to-treat (ITT) populations, assessed in an analysis of covariance model. Secondary outcomes included safety assessments, improvement in pain, swelling, tenderness and treatment response after 5 days, assessed using linear mixed models and binary logistic regression models.ResultsForty-three patients received anakinra and 45 treatment as usual. Anakinra was non-inferior (mean difference; 95% CI) to treatment as usual in both the PP (–0.13; –0.44, 0.18) and ITT (–0.18; –0.44, 0.08) populations. No unexpected or uncommon (serious) adverse events were observed in either treatment arm. Analyses of secondary outcomes showed that patients in both groups reported similar significant reductions in their gout symptoms.ConclusionEfficacy of anakinra was shown to be non-inferior to treatment as usual for the treatment of acute gout flares, suggesting that anakinra is an effective treatment alternative for acute gout flares.Trial registrationHet Nederlands Trial Register, www.trialregister.nl, NTR5234

Late Phase Inflammation during Nasal Grass and Ragweed Challenge in a Double-Blind Placebo Controlled Trial with Astemizole

1995 ◽  
Vol 9 (3) ◽  
pp. 169-174 ◽  
Author(s):  
Marianne Frieri ◽  
James Madden ◽  
Myron Zitt ◽  
Nanjundaiah S. Kumar ◽  
Maria Knapik
Keyword(s):  
Allergic Rhinitis ◽  
Nasal Congestion ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Interleukin 1 ◽  
Late Phase ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Nasal Provocation ◽  
Anti Inflammatory

Allergic rhinitis is an IgE-mediated inflammatory reaction characterized by an early “classic” immediate hypersensitivity response and/or a subsequent late phase response. Nasal provocation to antigen challenge is a useful method of evaluating this dual response. Several H1 antagonists may exhibit antiinflammatory properties by diminishing histamine release or inhibiting eosinophil chemotaxis. To determine whether astemizole has any anti-inflammatory characteristics, we studied 20 patients with allergic rhinitis in a double-blind placebo-controlled fashion after a 4-week course of treatment with this H1 antagonist. Nasal provocation over 30 minutes was performed out of season using increasing concentrations of grass or ragweed extract from 10–1000 PNU. Patients were evaluated for their clinical response, and nasal lavage secretions were analyzed over 6 hours by ELISA for alpha interleukin-1, interleukin-8, albumin, and histamine levels. Total sneezing and other symptom scores for rhinorrhea, nasal congestion, and pruritus were decreased in astemizole-treated compared to placebo-treated patients both at 30 minutes (early phase), and at 3 and 6 hours (late phase) after nasal provocation. However, these results did not reach statistical significance. Nasal α IL-1 levels diminished from diluent control lavage to a significantly greater degree in astemizole than in placebo-treated patients (P < 0.05). This diminution in late phase α IL-1 suggests that astemizole may possess anti-inflammatory properties.

A phase II randomized, double-blind placebo-controlled trial of an antiemetic, 6-gingerol in solid tumor patients receiving moderately to highly emetogenic adjuvant chemotherapy.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. 9647-9647 ◽  
Author(s):  
Jitprapa Konmun ◽  
Kwanjit Danwilai ◽  
Nuttapong Ngamphaiboon ◽  
Aumkhae Sookprasert ◽  
Ekaphop Sirachainan ◽  
...  
Keyword(s):  
Adjuvant Chemotherapy ◽  
Phase Ii ◽  
Solid Tumor ◽  
Controlled Trial ◽  
Tumor Patients ◽  
Double Blind ◽  
Double Blind Placebo
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