Clinical trials: sponsored by Hoffmann-La Roche
Breast Cancer
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal…
- Trial name
- NCT00022672
- Testing
- trastuzumab (Herceptin®), anastrazole (Arimidex®)
- Where
- 132 sites in United States, Australia and 24 more
- Volunteers
- 208 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study to Assess Capecitabine (Xeloda®) in Patients With Locally Advanced or Metastatic Breast Cancer
This 2 arm study compared the efficacy and safety of label dose of capecitabine (Xeloda®) to that of a lower dose of Xeloda® plus docetaxel (Taxotere®) in patients with locally advanced or metastatic breast cancer after failure…
- Trial name
- NCT00077857
- Testing
- capecitabine (Xeloda®), docetaxel (Taxotere®)
- Where
- 94 sites in United States, Bosnia and Herzegovina and 7 more
- Volunteers
- 470 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and…
- Trial name
- NCT01044498
- Testing
- Tocilizumab, Ortho-Novum® 1/35
- Where
- 6 sites in United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study of Tocilizumab (RoActemra/Actemra) Versus Adalimumab in Patients With Rheumatoid Arthritis
This randomized, blinded, parallel arm study evaluated the efficacy and safety of tocilizumab (RoActemra/Actemra) versus adalimumab as monotherapy in patients with rheumatoid arthritis who are intolerant of methotrexate or where…
- Trial name
- NCT01119859
- Testing
- Tocilizumab, Adalimumab
- Where
- 82 sites in United States, Australia and 13 more
- Volunteers
- 326 people
- Sponsor
- Hoffmann-La Roche
Spondylitis, Ankylosing
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Ankylosing Spondylitis Who Have Failed Treatment With NSAIDs
This randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with ankylosing spondylitis (AS) who have failed treatment with non-steroidal…
- Trial name
- NCT01209702
- Testing
- tocilizumab
- Where
- 139 sites in United States, Australia and 16 more
- Volunteers
- 306 people
- Sponsor
- Hoffmann-La Roche
Spondylitis, Ankylosing
A Study of Tocilizumab (RoActemra/Actemra) in Patients With Ankylosing Spondylitis Who Have Had an Inadequate Response to Previous Tumor Necrosis Factor (TNF) Antagonist Therapy
This randomized, double-blind, placebo-controlled study evaluated the safety and efficacy of tocilizumab (RoActemra/Actemra) in patients with ankylosing spondylitis (AS) who had an inadequate response to previous tumor necrosis…
- Trial name
- NCT01209689
- Testing
- Tocilizumab
- Where
- 140 sites in United States, Australia and 17 more
- Volunteers
- 113 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Xeloda (Capecitabine) in Women With High-Risk Breast Cancer
This 2 arm study will compare the efficacy and safety of Taxotere + Xeloda, versus Taxotere alone, following a regimen of Adriamycin plus Cytoxan in women with high-risk breast cancer.
- Trial name
- NCT00089479
- Testing
- capecitabine [Xeloda], Taxotere
- Where
- United States
- Volunteers
- 2,611 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to or are unable to…
- Trial name
- NCT00891020
- Testing
- tocilizumab [RoActemra/Actemra], Nonbiologic DMARDs of investigator's choice
- Where
- 227 sites in United States
- Volunteers
- 886 people
- Sponsor
- Hoffmann-La Roche
Influenza
A Study of Tamiflu (Oseltamivir) for Treatment of Influenza With a Focus on (H1N1) 2009 Flu Strain
This randomized, double-blind, multi-center study of Tamiflu (Oseltamivir) will evaluate the efficacy against viral activity, the effectiveness in resolving the disease symptoms, and the safety and tolerability in patients with…
- Trial name
- NCT01032837
- Testing
- Oseltamivir
- Where
- 100 sites in United States
- Volunteers
- 102 people
- Sponsor
- Hoffmann-La Roche
Colorectal Cancer
A Study of Avastin (Bevacizumab) in Combination With XELOX or FOLFOX-4 in Patients With Metastatic Colorectal Cancer.
This 2 arm study will compare the pharmacokinetics and safety of Avastin at steady state under 2 different dosing regimens, in combination with XELOX (oxaliplatin + Xeloda) or FOLFOX-4 (oxaliplatin, leucovorin and…
- Trial name
- NCT00349336
- Testing
- bevacizumab [Avastin], XELOX, FOLFOX-4
- Where
- 7 sites in Australia, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- Hoffmann-La Roche
Rheumatoid Arthritis
A Study of Tocilizumab in Combination With DMARDs in Patients With Moderate to Severe Rheumatoid Arthritis
This 2-arm study assessed the safety and efficacy of tocilizumab versus placebo, both in combination with disease modifying antirheumatic drugs (DMARDs), in regard to reduction in signs and symptoms, in patients with moderate to…
- Trial name
- ROSE (NCT00531817)
- Testing
- Tocilizumab, Permitted DMARDs
- Where
- 157 sites in United States, Puerto Rico
- Volunteers
- 619 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.
This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin…
- Trial name
- NCT00545233
- Testing
- peginterferon alfa-2a [Pegasys], ribavirin [Copegus], Pioglitazone
- Where
- 66 sites in United States, Puerto Rico
- Volunteers
- 155 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Intravenous or Subcutaneous Methoxy Polyethylene Glycol-Epoetin Beta (RO0503821, Mircera) in Chronic Kidney Disease Patients With Renal Anemia
This study assessed the long-term efficacy, safety, and tolerability of intravenous (iv) or subcutaneous (sc) methoxy polyethylene glycol-epoetin beta in chronic kidney disease patients with renal anemia.
- Trial name
- NCT00090753
- Testing
- Methoxy Polyethylene Glycol-Epoetin Beta, Epoetin alfa, Epoetin beta
- Where
- 249 sites in United States, Australia and 25 more
- Volunteers
- 1,228 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Subcutaneous Mircera in Patients With Chronic Kidney Disease, Not on Dialysis.
This 2 arm study will compare the efficacy and safety of Mircera and darbepoetin alfa in the treatment of anemia in patients with chronic kidney disease who are not on dialysis and who are receiving subcutaneous darbepoetin alfa…
- Trial name
- NCT00442702
- Testing
- Mircera, Darbepoetin alfa
- Where
- 91 sites in United States, Australia and 11 more
- Volunteers
- 228 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study of Mircera in Hemoglobin Control of Patients Transitioning to Dialysis.
This study will assess the efficacy and safety of methoxy polyethylene glycol-epoetin beta (Mircera) in the maintenance of hemoglobin levels in patients who have previously received treatment with epoetin alfa or darbepoetin…
- Trial name
- NCT00454246
- Testing
- methoxy polyethylene glycol-epoetin beta, epoetin alfa, darbepoetin alfa
- Where
- 78 sites in United States
- Volunteers
- 111 people
- Sponsor
- Hoffmann-La Roche
Anemia
A Study Comparing Mircera and Epoetin Alfa for the Treatment of Anemia in Dialysis Patients With Chronic Kidney Disease.
This 2 arm study will compare 'time and motion' (provider time spent on anemia management) and effect on hemoglobin (Hb) levels, of methoxy polyethylene glycol-epoetin beta (Mircera) and epoetin alfa, in anemic patients with…
- Trial name
- NCT00422513
- Testing
- methoxy polyethylene glycol-epoetin beta, Epoetin alfa
- Where
- 44 sites in United States
- Volunteers
- 260 people
- Sponsor
- Hoffmann-La Roche
Lupus Nephritis
A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.
This 2 arm study assessed the efficacy of Mycophenolate Mofetil (MMF; CellCept) compared to cyclophosphamide in inducing a response in patients with lupus nephritis, and the long term efficacy of MMF compared to azathioprine in…
- Trial name
- NCT00377637
- Testing
- Mycophenolate mofetil (MMF), Cyclophosphamide, Azathioprine
- Where
- 108 sites in United States, Argentina and 15 more
- Volunteers
- 370 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
GEMINI Study - A Study of Saquinavir/Ritonavir in Treatment-Naive Patients With HIV-1 Infection
This 2 arm study will evaluate the efficacy, safety and tolerability of saquinavir/ritonavir or lopinavir/ritonavir in combination with emtricitabine/tenofovir in patients with human immunodeficiency virus type 1 (HIV-1)…
- Trial name
- NCT00105079
- Testing
- saquinavir [Invirase], Lopinavir/ritonavir, Emtricitabine/tenofovir disoproxil fumarate
- Where
- 44 sites in United States, Canada and 3 more
- Volunteers
- 337 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
XeNA Study - A Study of Xeloda (Capecitabine) in Patients With Invasive Breast Cancer
This single arm study stratified patients into two treatment cohorts based on HER2-neu overexpression/amplification. Each cohort will be independently powered for the primary endpoint.
- Trial name
- NCT00127933
- Testing
- capecitabine [Xeloda], Taxotere, Herceptin (HER2-neu positive patients only)
- Where
- 38 sites in United States
- Volunteers
- 157 people
- Sponsor
- Hoffmann-La Roche
HIV Infections
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1 infected patients naive to Fuzeon and an…
- Trial name
- AMICI (NCT00488059)
- Testing
- enfuvirtide [Fuzeon], Optimized background ARV, Integrase inhibitor
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 29 people
- Sponsor
- Hoffmann-La Roche