22 results
Primary: To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient*s assessment of gout pain intensity in the target joint at 72 hours post-dose (on a 0-100mm VAS). To confirm that canakinumab…
Primary: Long term safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…
Primary: to demonstrate the superiority of at least one dose of canakinumab compared to placebo in reducing the risk of recurrent major cardiovascular disease events (cardiovascular death, non-fatal MI and stroke) in a population of clinically…
The purpose of this open-label phase III extension study is to collect additional long term safety and efficacy data on canakinumab in the treatment of SJIA from patients who qualify to roll-over into this study from the CACZ885G2305 and…
To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.Secondary Objectives * To assess the safety and tolerability of monthly 150 mg subcutaneousdoses of ACZ885 in subjects with AAA over a treatment…
Ergonomics and function of the imaging system - the NIRF imaging system should not interfere with the standard Sentinel Lymph Node mapping procedure and used safely by the surgeon while detection of ICG takes place. Duration: 1,5 hour clinical…
This study aims at evaluating whether indocyanin green (ICG) enhanced intra-operative near-infrared fluorescence (NIRF) imaging is as good as or even better than the standard technique (technetium-99 labeled colloid and Patent Blue) in detecting…
To test an intra-operative fluorescent camera system with a fluorescent optical agent in detection of the sentinel lymph node. This will be compared to the standard method with radiocolloid and patent blue.
Primary: To determine whether IL-1 inhibition by Canakinumab is efficacious in treatment of Schnitzler syndrome.Secondary:1. To assess the effect of canakinumab on Schnitzler syndrome (clinical signs/symptoms and inflammatory biomarkers C-reactive…
The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…
Aim of the present study is to investigate if a combination of a radioactive and fluorescent tracer can increase the sensitivity and specificity of the SLNM technique in colon and rectal cancer by utilizing the radioactive component for preoperative…
To determine which advanced image enhanced modality is the most feasible for the detection of endometriosis lesions, with respect to the specificity and sensitivity of the investigated modalities. To determine which imaging modality reveals more…
To demonstrate the additive IOP lowering effect of SIMBRINZA (dosed BID) when added to DUOTRAV solution in subjects with open-angle glaucoma or ocular hypertension.
Aim of the study is to develop an intraoperative technique for SLN mapping in colon cancer which is suitably in daily practice in colon surgery in an average hospital setting.
Primary Objective:-Evaluate tumour detection sensitivity and specificity with the following image enhancement modalities:1 *narrow-band imaging*, (NBI)2 *near-infrared indocyanin green imaging*, (ICG)3 *5-aminolevulinic acid fluorescent imaging*, (5…
Primary: The primary objective of the randomized treatment epoch and for the overall study is to demonstrate that subcutaneous canakinumab administered every 4 weeks is superior to placebo in achieving a clinically meaningful reduction of disease…
Primary: Safety run-in part (part 1):* to confirm tthe recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with docetaxel. Double-blind, randomized, placebo-controlled part (part 2):* to compare the overall survival (OS) between…
Primary: To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future dosesSecondary:* To characterize the pharmacokinetic profile of each investigational drug within each treatment arm…