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NCT ID: NCT01059773 Completed - Psoriasis Clinical Trials

A Safety and Efficacy Study of Ustekinumab in Patients With Plaque Psoriasis Who Have Had an Inadequate Response to Methotrexate

TRANSIT
Start date: October 2009
Phase: Phase 4
Study type: Interventional

This purpose of this study is to assess the safety of ustekinumab in psoriasis patients who receive ustekinumab following an inadequate response to methotrexate therapy. The study will provide information for doctors on how to manage the transfer from methotrexate to the biologic agent ustekinumab. The study is designed to compare two methods of transferring patients from methotrexate to ustekinumab. The two methods being compared are discontinuation of methotrexate with immediate initiation of ustekinumab versus initiation of ustekinumab with overlap and gradual dose reduction of methotrexate over 4 weeks.

NCT ID: NCT01059539 Completed - Bipolar I Disorder Clinical Trials

Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder

Start date: February 28, 2010
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.

NCT ID: NCT01058174 Completed - Clinical trials for Liver Transplantation

Liver Transplant European Study Into the Prevention of Fungal Infection

TENPIN
Start date: December 15, 2009
Phase: Phase 3
Study type: Interventional

Prevention of invasive fungal infection in high risk patients following liver transplant.

NCT ID: NCT01057810 Completed - Prostate Cancer Clinical Trials

Phase 3 Study of Immunotherapy to Treat Advanced Prostate Cancer

Start date: May 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if patients with metastatic prostate cancer who have not received chemotherapy live longer when treated with ipilimumab than those treated with a placebo

NCT ID: NCT01056341 Completed - Clinical trials for Infantile Hemangioma

Study to Demonstrate the Efficacy and Safety of Propranolol Oral Solution in Infants With Proliferating Infantile Hemangiomas Requiring Systemic Therapy

Start date: January 2010
Phase: Phase 2/Phase 3
Study type: Interventional

There is an unsatisfied medical need for a first-line treatment of proliferating IHs with a good benefit/risk profile. Based on the recent findings of encouraging results obtained with propranolol in a series of infants with severe Infantile Hemangioma (IH), propranolol is expected to be of significant benefit in the management of the condition. The present study has been designed to confirm efficacy of propranolol in severe IH by demonstrating superiority over placebo and to document the safety profile of propranolol in this indication.

NCT ID: NCT01054625 Completed - Clinical trials for Head and Neck Cancer

Zalutumumab Pharmacokinetics (PK) in Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Start date: March 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This study is to support current and future Zalutumumab studies by increasing the Pharmacokinetic (PK) knowledge of the drug. PK is the study of how a drug is absorbed (taken up), distributed (moved around), metabolised (broken down) and excreted (removed) by the body, in relation to time. The first PK trial only went up to 8 mg/kg, and, as there has been some indication that the PK profile for the higher and lower doses is different, this needs to be further evaluated. Furthermore, there is a need for more PK data on dosing with 16mg/kg. The aim with this study is therefore to evaluate the PK profiles at different doses of Zalutumumab and the amount of drug in the blood at different time points after single and multiple doses. The results of this study, combined with data from completed and ongoing Zalutumumab studies, will enable us to provide patients with an effective treatment option which may significantly prolong their survival and/or improve their quality of life.

NCT ID: NCT01052194 Completed - Clinical trials for Rheumatoid Arthritis

A 12-week Study of 4 Doses of VX-509 in Subjects With Active Rheumatoid Arthritis

Start date: February 2010
Phase: Phase 2
Study type: Interventional

This study is designed to evaluate safety and assess initial efficacy of VX-509, a JAK3 inhibitor, for treatment of subjects with active RA. This study will assess the clinical response of 4 doses of VX-509 compared to placebo when administered for 12 weeks to patients with active RA. The study will also evaluate the safety and tolerability of VX-509 compared to placebo when administered for 12 weeks to subjects with active RA.

NCT ID: NCT01051349 Completed - Clinical trials for Relapsing-Remitting Multiple Sclerosis

Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis

SELECTED
Start date: March 31, 2010
Phase: Phase 2
Study type: Interventional

Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.

NCT ID: NCT01050998 Completed - Clinical trials for Rheumatoid Arthritis

A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis

Start date: January 5, 2010
Phase: Phase 2
Study type: Interventional

The primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with moderately active Rheumatoid Arthritis (RA).

NCT ID: NCT01050257 Completed - Influenza Clinical Trials

A Study of Intravenously Administered Tamiflu (Oseltamivir) in Patients Over 13 Years of Age With Influenza

Start date: January 2010
Phase: Phase 3
Study type: Interventional

This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.