Hoffmann-La Roche

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A Single-Center, Double-Blind (DB) Study of MEM 3454 on P50 Sensory Gating and Mismatch Negativity in Schizophrenia Patients

The purpose of this study is to evaluate the effects of nicotinic alpha-7 MEM 3454 on P50 sensory gating in patients with Schizophrenia. The hypothesis is that MEM 3454 will normalize the P50 ratio. Data produced in this study will provide useful information regarding the value of P50 as an efficacy biomarker, and provide evidence for the optimal dosing of MEM 3454 for additional P50 studies.

Background information
Other unique IDs: 
MEM 3454-102

Phase IV Study to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation

Trial phase: 
Phase IV
Recruitment status: 
Recruiting

Current practice of immune suppressive standard therapy after renal transplantation in non-risk patients is a triple therapy consisting of steroids, a calcineurin inhibitor and MMF. The aim of this clinical trial is to combine a reduction of CNI using tacrolimus and a concept of not using steroids in order to establish an immunosuppressive regimen in immunologically non-risk patients that is efficient and causes as few side effects as possible.

Background information
Trial ID: 
NCT00724022
Other unique IDs: 
IT1850071
EudraCT No. 2007-006516-31
Official title: 

Triple Arm, Prospectively Randomized Multi Centre Study Phase IV to Evaluate Calcineurin Inhibitor Reduced, Steroid Free Immunosuppression After Renal Transplantation in Non-Risk Patients

Detailed description: 

In this triple arm, prospectively randomized multi centre phase IV study 200 patients per study arm will be investigated for 12 months. Based on the results of the Symphony study the low dose tacrolimus study arm will be modified to further improve efficacy (prevention of BPAR, best possible renal function) and safety (adverse event profile regarding infections, cardiovascular risk factors, malignant tumours) of immunosuppression.

Number to be enrolled: 
600 patients
Acronym: 
Harmony

A Dose-Escalation Study of RO5083945 in Patients With Metastatic and/or Locally Advanced Malignant Epidermal Growth Factor Receptor (EGFR)+ Solid Tumors.

Trial phase: 
Phase I
Recruitment status: 
Recruiting

This study will evaluate the pharmacokinetics, maximum tolerated dose and anti-tumor activity of RO5083945 in patients with metastatic and/or locally advanced malignant EGFR+ solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending doses of RO5083945 administered weekly, every 2 weeks or every 3 weeks. The starting dose of 50mg weekly will be escalated in subsequent groups of patients after a successful assessment of the safety, tolerability and pharmacokinetics of the previous dose. In Part 2 of the study, patients with EGFR+ and mutant KRAS colorectal cancer will be enrolled, and will receive RO5083945 at the recommended dose and regimen identified in Part 1. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Background information
Trial ID: 
NCT00721266
Other unique IDs: 
BO21495
2007-005939-28
Official title: 

An Open Label, Dose-Escalation Study to Evaluate Safety, Pharmacokinetics and Tumor Growth Control Rate of RO5083945, a Glycoengineered Antibody Against EGFR, in Patients With Metastatic and/or Locally Advanced Malignant EGFR+ Solid Tumors.

Detailed description: 

 

Number to be enrolled: 
100 patients

A Study of Tocilizumab in Patients Completing Treatment in WA17822

Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

This single arm study will evaluate the long-term efficacy and safety of tocilizumab in patients who have completed treatment in the tocilizumab WA17822 study of adults with rheumatoid arthritis. Patients will receive tocilizumab alone or in combination with standard anti-rheumatic treatment. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Background information
Trial ID: 
NCT00721123
Other unique IDs: 
WA18695
Official title: 

Long-Term Extension Study of Safety During Treatment With Tocilizumab in Rheumatoid Arthritis Patients Completing Treatment in WA17822

Detailed description: 

 

Number to be enrolled: 
630 patients

An Extension Study of Tocilizumab in Patients Completing Treatment in Tocilizumab Core Studies

Trial phase: 
Phase III
Recruitment status: 
Active, not recruiting

This single arm study will evaluate the long-term efficacy and safety of tocilizumab in patients who have completed treatment in the tocilizumab core studies of adults with rheumatoid arthritis. Patients will receive tocilizumab alone or in combination with standard anti-rheumatic treatment. The anticipated time on study treatment is 2+ years, and the target sample size is 500+ individuals.

Background information
Trial ID: 
NCT00720798
Other unique IDs: 
WA18696
Official title: 

Long-Term Extension Study of Safety During Treatment With Tocilizumab in Rheumatoid Arthritis Patients Completing Treatment in Tocilizumab Core Studies WA18062, WA18063 and WA17824

Detailed description: 

 

Number to be enrolled: 
2068 patients

Safety and Efficacy of Bevacizumab Plus RAD001 Versus Interferon Alfa-2a and Bevacizumab in Adult Patients With Kidney Cancer

Trial phase: 
Phase II
Recruitment status: 
Recruiting

To estimate the difference in efficacy and safety of bevacizumab and RAD001 compared to bevacizumab and interferon alfa-2a for first-line treatment of patients with metastatic carcinoma of the kidney.

Background information
Trial ID: 
NCT00719264
Other unique IDs: 
CRAD001L2201
Official title: 

A Randomized, Open-Label, Multi-Center Phase II Study to Compare Bevacizumab Plus RAD001 Versus Interferon Alfa-2a Plus Bevacizumab for the First-Line Treatment of Patients With Metastatic Clear Cell Carcinoma of the Kidney

Detailed description: 

 

Number to be enrolled: 
360 patients
Acronym: 
L2201

A Study of Maintenance Treatment With MabThera (Rituximab) in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia

Trial phase: 
Phase III
Recruitment status: 
Not yet recruiting

This study will assess the effect of maintenance treatment with MabThera,in comparison with a 2 year observation period (no treatment),in patients with progressive B-cell chronic lymphocytic leukemia who have had previous first-line induction treatment with MabThera (RCC regimen).After 6 months of induction therapy with RCC (MabThera + cladribine + cyclophosphamide) patients will be randomized either to receive maintenance treatment with MabThera (375mg/m2 iv every 12 weeks, or to receive no treatment (observation only).The anticipated time on study treatment is 2+ years, and the target sample size is 100-500 individuals.

Background information
Trial ID: 
NCT00718549
Other unique IDs: 
ML21283
2008-001140-39
Official title: 

A Randomized, Open Label Study to Assess the Effect of Maintenance Treatment With MabThera vs no Treatment, After Induction With MabThera, Cladribine and Cyclophosphamide on Progression-Free Survival in Previously Untreated Patients With Progressive B-CLL

Detailed description: 

 

Number to be enrolled: 
200 patients

A Study of Verutex (Fusidic Acid), Eritex (Erythromycin) and Fisiogel in the Management of Tarceva-Associated Rash.

Trial phase: 
Phase III
Recruitment status: 
Recruiting

This 3 arm study will compare the efficacy and safety of three different dermatological creams designed for prophylaxis of skin rash associated with Tarceva treatment in patients with locally advanced or metastatic non-small cell lung cancer. Eligible patients who have recently started Tarceva treatment will be randomized to one of 3 groups, to receive daily treatment with Verutex, Eritex or Fisiogel cream for 30 days, and the incidence and severity of skin rash will be assessed. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Background information
Trial ID: 
NCT00718315
Other unique IDs: 
ML21450
Official title: 

A Randomized, Open Label Study to Compare the Use of the Dermatological Creams Verutex, Eritex and Fisiogel in the Management of Skin Rash Associated With Tarceva Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer.

Detailed description: 

 

Number to be enrolled: 
312 patients

A Study of Once Monthly Intravenous or Subcutaneous Mircera in Patients With Chronic Kidney Disease on Hemodialysis.

Trial phase: 
Phase III
Recruitment status: 
Recruiting

This 2 arm study will compare the hemoglobin maintenance with once monthly Mircera administration versus epoetin beta or darbepoetin alfa in patients with chronic kidney disease on hemodialysis. Patients will be randomized to receive either monthly s.c. or i.v. Mircera (at a starting dose of 120 or 200 micrograms, calculated from the last weekly dose of epoetin beta or darbepoetin alfa previously administered), or standard therapy (iv or sc epoetin beta once, twice or thrice weekly, or iv or sc darbepoetin alfa once a week or twice a week). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Background information
Trial ID: 
NCT00717821
Other unique IDs: 
ML21145
Official title: 

A Randomized, Controlled, Open Label, French Multicenter Parallel Group Study to Compare the Hemoglobin Maintenance With Once Monthly Administration of Mircera Versus Epoetin Beta or Darbepoetin Alfa in Patients With Chronic Kidney Disease on Hemodialysis

Detailed description: 

 

Number to be enrolled: 
600 patients

A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

Trial phase: 
Phase III
Recruitment status: 
Recruiting

This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 2+ years, and the target sample size is >500 individuals.

Background information
Trial ID: 
NCT00717457
Other unique IDs: 
BC21625
2008-001856-36
Official title: 

Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as Add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus

Detailed description: 

 

Number to be enrolled: 
990 patients
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