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NCT ID: NCT00548405 Completed - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

Comparison of Alemtuzumab and Rebif® Efficacy in Multiple Sclerosis, Study Two

CARE-MS II
Start date: October 2007
Phase: Phase 3
Study type: Interventional

The purpose of this study was to establish the efficacy and safety of two different doses of alemtuzumab (Lemtrada™) as a treatment for relapsing-remitting multiple sclerosis (MS), in comparison with subcutaneous interferon beta-1a (Rebif®). The study enrolled participants who had received an adequate trial of disease-modifying therapies but experienced at least 1 relapse during prior treatment, and who met a minimum severity of disease as measured by magnetic resonance imaging (MRI). Participants had monthly laboratory tests and comprehensive testing every 3 months.

NCT ID: NCT00548262 Completed - Candidemia Clinical Trials

This Is An Open-Label, Non-Comparative Study Designed To Evaluate A Short Course Of IV Anidulafungin, Followed Optionally By Oral Voriconazole, For The Treatment Of Candidemia And Invasive Candidiasis

Start date: February 2008
Phase: Phase 4
Study type: Interventional

The primary objective is to estimate global response rate. Clinical, microbiological and global response rates and its 95% confidence intervals will be computed. No hypotheses will be tested.

NCT ID: NCT00547521 Completed - Clinical trials for Rheumatoid Arthritis (RA)

Phase IIIB Subcutaneous Abatacept Monotherapy Study

Start date: December 2007
Phase: Phase 3
Study type: Interventional

To evaluate safety and immunogenicity of abatacept when used with or without methotrexate in the absence of an IV loading dose of abatacept

NCT ID: NCT00545688 Completed - Breast Cancer Clinical Trials

A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

Start date: June 2006
Phase: Phase 2
Study type: Interventional

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

NCT ID: NCT00545532 Completed - Influenza, Human Clinical Trials

A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Start date: February 4, 2008
Phase: Phase 3
Study type: Interventional

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

NCT ID: NCT00545129 Completed - Neoplasm Metastasis Clinical Trials

A Study Of Tanezumab as Add-On Therapy to Opioid Medication In Patients With Pain Due To Cancer That Has Spread To Bone

Start date: April 29, 2009
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of tanezumab in combination with opioids in treating pain due to cancer that has spread to bone.

NCT ID: NCT00543725 Completed - HIV Infections Clinical Trials

TMC278-TiDP6-C215: A Clinical Trial in Treatment Naive HIV-subjects Patients Comparing TMC278 to Efavirenz in Combination With 2 Nucleoside/Nucleotide Reverse Transcriptase Inhibitors

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to compare the effectiveness, safety and tolerability of TMC278 given at a dose of 25 mg once daily versus efavirenz (EFV) at a dose of 600 mg once daily, when combined with a background regimen containing 2 nucleoside/nucleotide reverse transcriptase inhibitors ( investigator choice of ABC/3TC, TDF/FTC or AZT/3TC) in HIV-1 infected patients who have not yet taken any anti-HIV drugs. The following evaluations will be done: antiviral activity, immunologic changes, and viral geno-/phenotype evolution, relationship of Pharmacokinetics (PK) and PK/Pharmacodynamics and Medical resource utilization and treatment adherence.

NCT ID: NCT00543439 Completed - Hemophilia A Clinical Trials

Study Evaluating Prophylaxis Treatment & Characterizing Efficacy, Safety, & PK Of B-Domain Deleted Recombinant FVIII

Start date: December 2007
Phase: Phase 3
Study type: Interventional

The purpose of this research study is to determine the effectiveness, safety, and pharmacokinetics (PK) of moroctocog alfa (AF-CC) in previously treated subjects, who are younger than 6 years of age, with severe or moderately severe hemophilia A.

NCT ID: NCT00542919 Completed - B-Cell Lymphoma Clinical Trials

A Study for Patients With Non-Hodgkin's Lymphomas

Start date: November 2007
Phase: Phase 2
Study type: Interventional

In this study, all patients will get investigational drug. There will be no comparator drug. This study will evaluate three tumor types: T-cell lymphoma, Indolent B-cell lymphoma, and Aggressive B-cell lymphoma. Each tumor type will include several tumor subtypes: - T-cell lymphoma: Peripheral and Cutaneous T-cell lymphoma (PTCL, CTCL) - Indolent B-cell lymphoma: Small lymphocytic lymphoma, follicular lymphoma (Gr 1 or 2) and marginal zone lymphoma - Aggressive B-cell lymphoma: Primary CNS lymphoma, follicular lymphoma (Gr 3a and 3b) and aggressive lymphoma with prior clinical history of indolent lymphoma.

NCT ID: NCT00542009 Completed - Weight Management Clinical Trials

A Trial In Diabetic Patients To Assess Effect Of CE-326,597 On Glucose Control And Body Weight

Start date: December 2007
Phase: Phase 2
Study type: Interventional

Study of whether the investigational drug CE-326,597 improves glucose control and results in body weight loss in patients with type 2 diabetes