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NCT ID: NCT01063595 Completed - Clinical trials for Comparison of Octaplas LG and Octaplas SD

A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD

Start date: December 2009
Phase: Phase 1
Study type: Interventional

The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.

NCT ID: NCT01063101 Completed - Healthy Volunteers Clinical Trials

Phase 1 Dosing Study of BAX 513 in Healthy Volunteers

Start date: January 29, 2010
Phase: Phase 1
Study type: Interventional

The purpose of the study is to investigate whether orally administered BAX 513 (different doses administered for 5 days) affects hemostatic parameters in healthy volunteers.

NCT ID: NCT01063088 Completed - Influenza Clinical Trials

Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine

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

The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal influenza vaccine with strain composition according to World Health Organization (WHO)/European Union (EU) recommendation for the 2009/2010 season.

NCT ID: NCT01062607 Completed - Bipolar Disorders Clinical Trials

Study of the Clinical Management of Bipolar Disease

WAVE bd
Start date: April 2010
Phase: N/A
Study type: Observational

This study is to provide reliable information on the management of bipolar disorders in real every day, clinical practice, to determine the clinical outcomes of such management and use of resources in relation to the disease, and to establish the factors associated with different management patterns and clinical outcomes.

NCT ID: NCT01061736 Completed - Clinical trials for Rheumatoid Arthritis

Evaluation of Sarilumab (SAR153191/REGN88) on Top of Methotrexate in Rheumatoid Arthritis Patients

RA-MOBILITY
Start date: March 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Primary Objectives: Part A (dose ranging study): To demonstrate that sarilumab (SAR153191/REGN88) on top of MTX was effective on reduction of signs and symptoms of rheumatoid arthritis at 12 weeks. Part B (pivotal study): To demonstrate that sarilumab added to MTX was effective in: - reduction of signs and symptoms of rheumatoid arthritis at 24 weeks - inhibition of progression of structural damage at 52 weeks - improvement in physical function at 16 weeks Secondary Objectives: Part B: To demonstrate that sarilumab added to MTX was effective in induction of a major clinical response at 52 weeks To assess the safety of sarilumab added to MTX To document the pharmacokinetic profile of sarilumab added to MTX in participants with active rheumatoid arthritis who were inadequate responders to MTX therapy.

NCT ID: NCT01061723 Completed - Clinical trials for Ankylosing Spondylitis

Dose Ranging Study to Evaluate the Efficacy and Safety of SAR153191 (REGN88) in Patients With Ankylosing Spondylitis

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

Primary objective: - to evaluate the efficacy of Sarilumab in patients with Ankylosing Spondylitis [AS] using the Assessment in AS working group criteria [ASAS] 20% response criteria [ASAS20] Secondary objectives: - to demonstrate that Sarilumab is effective on: - assessment of higher level of response (ASAS 40% response criteria [ASAS40]) - partial remission - disease activity - range of motion - Magnetic Resonance Imaging [MRI] of the spine - to assess the safety and tolerability of Sarilumab in patients with AS as well as the pharmacokinetic profile of Sarilumab in patients with AS

NCT ID: NCT01061567 Completed - Parkinson's Disease Clinical Trials

Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

Start date: November 2009
Phase: N/A
Study type: Observational

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.

NCT ID: NCT01061177 Completed - Leukemia, Myeloid Clinical Trials

Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome and /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

`MACS1252
Start date: May 2010
Phase: Phase 4
Study type: Interventional

This study will assess the efficacy and safety of nilotinib in adult patients with newly diagnosed Philadelphia chromosome positive/BCR-ABL positive chronic myeloid leukaemia in chronic phase. The aim of the study is to confirm the rates of complete molecular remission (CMR) of nilotinib in newly diagnosed CML chronic phase patients in a pan-European population using the EUTOS standardized laboratories.

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: NCT01059630 Completed - Clinical trials for Non-Hodgkin's Lymphoma

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

Start date: April 30, 2010
Phase: Phase 3
Study type: Interventional

This open-label, multicenter, randomized Phase III study will investigate the efficacy, safety, pharmacokinetics and pharmacoeconomics of obinutuzumab (RO5072759, GA101) combined with bendamustine followed by continued obinutuzumab treatment (maintenance monotherapy) compared with bendamustine alone treatment in participants with rituximab-refractory indolent Non-Hodgkin's lymphoma (iNHL). The end of study was defined to when safety follow-up for all patients had been completed (2 years' safety follow-up from last dose).