ANZCTR search results

This is a Phase 3, multicenter, placebo-controlled, randomized, double-blind study to evaluate the efficacy, safety, tolerability, and immunogenicity of epratuzumab in subjects with moderate to severe general systemic lupus erythematosus (SLE). The study population consists of subjects (>=18 years of age) receiving a stable dose of corticosteroids (5 to 60mg/day prednisone equivalents) for at least 5 days (±1 day) prior to Week 0 (Visit 2) and the first dose of study drug. Subjects must have a diagnosis of SLE by the American College of Rheumatology (ACR) revised criteria, such that at least 4 (not including Neurologic Disorder) of the 11 criteria are met (if positive for Neurologic Disorder criteria, a total of 5 of the 11 ACR criteria must be met). In addition, subjects must have British Isles Lupus Assessment Group (BILAG) Index (version 2004) level A disease activity in at least 1 body/organ system, or BILAG level B disease activity in at least 2 body/organ systems at Baseline among the BILAG-defined mucocutaneous, musculoskeletal, or cardiorespiratory body systems, and active moderate to severe SLE disease activity as demonstrated by a Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) total score of at least 6. Approximately 1053 subjects will be enrolled to randomize 780 subjects in this study. For each subject, the study will last a maximum of 54 weeks and will consist of a Screening Period (1 to 14 days), a double-blind Treatment Period consisting of four 12-week treatment cycles (48 weeks total), and a Safety Follow-Up Visit for subjects not participating in the open-label extension study, SL0012, at 13 weeks from their final dose of study drug, or a maximum of 4 weeks beyond Week 48 (ie, no later than Week 52). Eligible subjects will be randomized in a 1:1:1 ratio as follows: Epratuzumab 600mg infusions delivered once a week (QW) for a total of 4 weeks (cumulative dose [CMD] 2400mg) over four 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, and 39) Epratuzumab 1200mg infusions delivered every other week (QOW) for a total of 4 weeks (CMD 2400mg) over four 12-week treatment cycles (ie, Weeks 0, 2, 12, 14, 24, 26, 36, and38); and placebo (PBO) infusions delivered QOW for a total of 4 weeks over four 12-week treatment cycles (ie, Weeks 1, 3, 13, 15, 25, 27, 37, and 39) PBO infusions delivered QW for a total of 4 weeks over four 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, and 39) The primary objective of the study is to confirm the clinical efficacy of epratuzumab in the treatment of subjects with moderate to severe general SLE despite standard of care treatments (ie, corticosteroids, and potentially antimalarials and immunosuppressants) continued from Baseline. The secondary objectives of the study are to assess the safety, tolerability, and immunogenicity of epratuzumab, and to assess the steroid-sparing effects of epratuzumab treatment. The exploratory objectives of the study are to assess the pharmacokinetics (PK) of epratuzumab; the effects of epratuzumab treatment on individual components of the combined response index, fatigue associated with moderate to severe SLE, and the health-related quality of life (HRQoL) and utility benefits of epratuzumab treatment.

The Sydney Multisite Intervention of Laughterbosses and ElderClowns (SMILE) is a trial of humour therapy in aged care. The study will recruit 36 hostels and nursing homes, and half of these faciilties will be randomly assigned to receive humour therapy (intervention) or usual care (control). The intevention comprises ElderClowns visiting residents on a weekly basis, and volunteer staff in to be trained as LaughterBosses to bring humour into dialy care routines. About 400 residents will be assessed at three timepoints during the trial to test the hypotheis that humour may improve quality of life, engagement, and mood (e.g. depression).

Atypical hemolytic-uremic syndrome is a serious, life-threatening rare and chronic disease believed to be caused by genetic mutations. Current treatment for the disease is inadequate. Due to the uncontrolled complement activation seen in aHUS patients and the previously shown activity of eculizumab to selectively inhibit terminal complement activation, it has been decided to look in to the use of eculizumab in the treatment of severely affected aHUS patients.

The aim of this study was to determine if the ointment called Glyceryl Trinitrate or Rectogesic by trade name is beneficial in reducing pain after stapled haemorrhoidectomy. Patients will be assigned to either one of two groups and will receive either Rectogesic or standard post op Analgesia.

This single blinded randomised controlled trial aims to investigate the relative effectiveness of two models of physiotherapy rehabilitation post lower limb Botulinum Toxin A (BoNTA) injections. Traditional individual rehabilitation will be compared to a group-based model for children aged 4-14 years with Cerebral Palsy (CP) attending the Queensland Cerebral Palsy Health Service (QCPHS) for BoNTA injections.

Individuals who present to the Emergency Department with severe infections are treated with fluids in the vein to maintain optimal blood volume, keep the heart working properly, and keep tissues well oxygenated. There are a number of fluids that Emergency Physicians can provide to patients including saline and 4% albumin. Further work is required to determine which of these fluids is most effective in improving the outcome of patients with severe infection. This project aims to determine whether 4% albumin solution is superior to crystalloid solutions for fluid resuscitation of patients presenting to the Emergency Department (ED) with septic shock. A randomised controlled trial is proposed, in which 100 patients will be enrolled over 2 years, each assigned to receive either 4% albumin or crystalloid fluids for the first six hours of resuscitation in the ED. All other aspects of care will be common to both groups and according to evidence-based guidelines. A variety of outcomes will be measured, including organ dysfunction scores, inflammatory markers and measures of circulation.

Can home medicine reviews improve health outcomes when directed at patients after acute coronary syndrome.

The aim of this study is to determine whether thoracic kyphosis (stooped posture)can be reduced using two commonly used treatment modalities. The first, postural re-education, was found in a recent survey to be the most commonly used treatment modality amongst Australian Physiotherapists. The second, progressive resisted strengthening is supported by level 1 evidence in terms of strengthening but not reduction of kyphosis. The study involves the assessment of these strategies seperately, together and not at all in both a stroke and a non stroke poulation.

The LenSx laser system is a femtosecond laser that has received 510(k) clearance (USA FDA) for anterior capsulotomy during cataract surgery, laser phacofragmentation during cataract surgery and for use in the creation of a single and multi-plan arc cut/incisions in the cornea. During cataract surgery, the LenSx Laser creates corneal incisions to allow the surgeon to enter the anterior chamber of the eye. It also creates a circular incision on the anterior capsule at a pre-programmed diameter to allow the surgeon to remove the cataractous lens. Lastly, the laser creates incisions within the cataractous crystalline lens to create fragmented pieces that are easy to manipulate, emulsify and aspirate with a phacoemulsification device. The objective of this study is to observe the performance of the cleared 510(k) device by assessing the laser created anterior capsulotomy, phacofragmentation, and/or corneal incisions when attempted, as well as to compare standard visual outcomes and commercial experience between laser and manual completion of standard cataract surgery procedures.