scholarly journals FTY720 combined with tacrolimus in de novo renal transplantation: 1-year, multicenter, open-label randomized study

2011 ◽  
Vol 26 (11) ◽  
pp. 3802-3805 ◽  
Author(s):  
Andries J. Hoitsma ◽  
Ervin S. Woodle ◽  
Daniel Abramowicz ◽  
Pieter Proot ◽  
Yves Vanrenterghem
Keyword(s):  
Renal Transplantation ◽  
De Novo ◽  
Randomized Study ◽  
Open Label

scholarly journals Intermittent BRAF inhibition in advanced BRAF mutated melanoma results of a phase II randomized trial

2021 ◽  
Vol 12 (1) ◽  
Author(s):  
Maria Gonzalez-Cao ◽  
Clara Mayo de las Casas ◽  
Juana Oramas ◽  
Miguel A. Berciano-Guerrero ◽  
Luis de la Cruz ◽  
...  
Keyword(s):  
Phase Ii ◽  
De Novo ◽  
Randomized Study ◽  
Progression Free Survival ◽  
Antitumoral Activity ◽  
De Novo Mutations ◽  
Intermittent Schedule ◽  
Open Label ◽  
Braf Inhibition ◽  
Emergence Of Resistance

AbstractCombination treatment with BRAF (BRAFi) plus MEK inhibitors (MEKi) has demonstrated survival benefit in patients with advanced melanoma harboring activating BRAF mutations. Previous preclinical studies suggested that an intermittent dosing of these drugs could delay the emergence of resistance. Contrary to expectations, the first published phase 2 randomized study comparing continuous versus intermittent schedule of dabrafenib (BRAFi) plus trametinib (MEKi) demonstrated a detrimental effect of the “on−off” schedule. Here we report confirmatory data from the Phase II randomized open-label clinical trial comparing the antitumoral activity of the standard schedule versus an intermittent combination of vemurafenib (BRAFi) plus cobimetinib (MEKi) in advanced BRAF mutant melanoma patients (NCT02583516). The trial did not meet its primary endpoint of progression free survival (PFS) improvement. Our results show that the antitumor activity of the experimental intermittent schedule of vemurafenib plus cobimetinib is not superior to the standard continuous schedule. Detection of BRAF mutation in cell free tumor DNA has prognostic value for survival and its dynamics has an excellent correlation with clinical response, but not with progression. NGS analysis demonstrated de novo mutations in resistant cases.

1949: Six Month Randomized Study Comparing Cyclosporine Microemulsion with C2 Monitoring and Tacrolimus in De Novo Kidney Transplantation

2004 ◽  
Vol 171 (4S) ◽  
pp. 515-515
Author(s):  
Felipe G. Balbontin ◽  
Bryce Kiberd ◽  
Philip Belitsky ◽  
Dharm Singh ◽  
Albert Fraser ◽  
...  
Keyword(s):  
Kidney Transplantation ◽  
De Novo ◽  
Randomized Study ◽  
C2 Monitoring ◽  
Cyclosporine Microemulsion

scholarly journals Early combination therapy with etanercept and methotrexate in JIA patients shortens the time to reach an inactive disease state and remission: results of a double-blind placebo-controlled trial

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Ekaterina Alexeeva ◽  
Gerd Horneff ◽  
Tatyana Dvoryakovskaya ◽  
Rina Denisova ◽  
Irina Nikishina ◽  
...  
Keyword(s):  
Combination Therapy ◽  
Controlled Trial ◽  
Randomized Study ◽  
Primary Objective ◽  
Disease State ◽  
Inactive Disease ◽  
Open Label ◽  
Standard Regimen ◽  
Double Blind ◽  
Early Combination Therapy

Abstract Background Remission is the primary objective of treating juvenile idiopathic arthritis (JIA). It is still debatable whether early intensive treatment is superior in terms of earlier achievement of remission. The aim of this study was to evaluate the effectiveness of early etanercept+methotrexate (ETA+MTX) combination therapy versus step-up MTX monotherapy with ETA added in refractory disease. Methods A multi-centre, double-blind, randomized study in active polyarticular JIA patients treated with either ETA+MTX (n = 35) or placebo+MTX (n = 33) for up to 24 weeks, followed by a 24-week open-label phase. The efficacy endpoints included pedACR30 criteria improvement at week 12, inactive disease at week 24, and remission at week 48. Patients who failed to achieve the endpoints at week 12 or at week 24 escaped to open-label ETA+MTX. Safety was assessed at each visit. Results By intention-to-treat analysis, more patients in the ETA+MTX group reached the pedACR30 response at week 12 (33 (94.3%)) than in the placebo+MTX group (20 (60.6%); p = 0.001). At week 24, comparable percentages of patients reached inactive disease (11 (31.4%) vs 11 (33.3%)). At week 48, 11 (31.4%) and eight (24.2%) patients achieved remission. The median (+/−IQR) times to achieve an inactive disease state in the ETA+MTX and placebo+MTX groups were 24 (14–32) and 32 (24–40) weeks, respectively. Forty-four (74/100 patient-years) adverse events (AEs) were reported, leading to treatment discontinuation in 6 patients. Conclusions Early combination therapy with ETA+MTX proved to be highly effective compared to the standard step-up regimen. Compared to those treated with the standard regimen, more patients treated with a combination of ETA+MTX reached the pedACR30 response and achieved inactive disease and remission more rapidly.

scholarly journals A Phase II Safety and Efficacy Study on Prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy

2021 ◽  
Author(s):  
Raman R S ◽  
Vijaykumar Bhagwan Barge ◽  
Anil Kumar Darivenula ◽  
Himanshu Dandu ◽  
Rakesh R Kartha ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Randomized Study ◽  
Standard Of Care ◽  
Immunoglobulin Therapy ◽  
Clinical Trial Registry ◽  
Open Label ◽  
Intravenous Immunoglobulin Therapy ◽  
Safety And Efficacy ◽  
Therapeutic Benefits ◽  
Wide Range

Abstract Background Currently, there is no specific drug for the treatment of COVID-19. Therapeutic benefits of intravenous immunoglobin (IVIG) have been demonstrated in wide range of diseases. The present study is conducted to evaluate the safety and efficacy of IVIG in the treatment of COVID-19 patients with moderate pneumonia. Methods An open-label, multicenter, comparative, randomized study was conducted on COVID-19 patients with moderate pneumonia. 100 eligible patients were randomized in 1:1 ratio either to receive IVIG + standard of care (SOC) or SOC. Results Duration of hospital stay was significantly shorter in IVIG group to that of SOC alone (7.7 Vs. 17.5 days). Duration for normalization of body temperature, oxygen saturation and mechanical ventilation were significantly shorter in IVIG compared to SOC. Percentages of patients on mechanical ventilation in two groups were not significantly different (24% Vs. 38%). Median time to RT-PCR negativity was significantly shorter with IVIG than SOC (7 Vs.18 days). There were only mild to moderate adverse events in both groups except for one patient (2%), who died in SOC. Conclusions IVIG was safe and efficacious as an adjuvant with other antiviral drugs in the treatment of COVID-19. The trial was registered under Clinical Trial Registry, India (CTRI/2020/06/026222).

Rabbit-ATG or basiliximab induction for rapid steroid withdrawal after renal transplantation (Harmony): an open-label, multicentre, randomised controlled trial

The Lancet ◽  
2016 ◽  
Vol 388 (10063) ◽  
pp. 3006-3016 ◽  
Author(s):  
Oliver Thomusch ◽  
Michael Wiesener ◽  
Mirian Opgenoorth ◽  
Andreas Pascher ◽  
Rainer Peter Woitas ◽  
...  
Keyword(s):  
Renal Transplantation ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Steroid Withdrawal ◽  
Open Label ◽  
Randomised Controlled

scholarly journals Tacrolimus Once Daily (ADVAGRAF) Versus Twice Daily (PROGRAF) in De Novo Renal Transplantation: A Randomized Phase III Study

2010 ◽  
Vol 10 (12) ◽  
pp. 2632-2643 ◽  
Author(s):  
B. K. Krämer ◽  
B. Charpentier ◽  
L. Bäckman ◽  
H. Tedesco Silva Jr ◽  
G. Mondragon-Ramirez ◽  
...  
Keyword(s):  
Renal Transplantation ◽  
De Novo ◽  
Phase Iii ◽  
Once Daily ◽  
Phase Iii Study

Pharmacokinetics, safety, and tolerability of four 28-day cycle intramuscular injections for risperidone-ISM 75 mg in patients with schizophrenia: A phase-2 randomized study (PRISMA-2)

2016 ◽  
Vol 33 (S1) ◽  
pp. s240-s241 ◽  
Author(s):  
L. Anta ◽  
J. Llaudó ◽  
I. Ayani ◽  
B. Gorostidi ◽  
M. Monreal ◽  
...  
Keyword(s):  
Injection Site ◽  
Drug Administration ◽  
Randomized Study ◽  
Deltoid Muscle ◽  
Study Medication ◽  
Open Label ◽  
Active Moiety ◽  
Intramuscular Injections ◽  
Competing Interest ◽  
Long Acting

IntroductionRisperidone-ISM is a new long acting intramuscular formulation of risperidone, for monthly administration without oral supplementation.ObjectiveTo characterize the pharmacokinetic of risperidone over multiple intramuscular injections in patients with schizophrenia.MethodA multicenter, open label, two-arm, parallel design clinical trial was performed. Each patient received 4 intramuscular injections of 75 mg of risperidone-ISM in either, gluteal or deltoid muscle at 28-day intervals.ResultsA total of 70 patients were randomized, 67 received at least one dose of study medication. Preliminary data show that mean Cmax of the active moiety was achieved 24-48 hours (Tmax) after each administration and ranged over four consecutive doses from 39.6-53.2 ng/mL and 54.1-61 ng/mL, when given in gluteal or deltoid, respectively. All subjects achieved therapeutic levels (> 7.5 ng/mL for the active moiety) between 2-8 hours after drug administration. The mean concentrations were maintained above therapeutic levels throughout the 4-week dosing period. No significance changes across the study were observed, either on Positive and Negative Syndrome Scale or Extrapyramidal Symptoms Scale. Overall, 63 subjects (94%) experienced at least 1 Treatment Emergent Adverse Event (TEAE) during the study. One serious TEAE (dystonia) was related to study treatment. One death not related to study medication was informed. The most frequently reported TEAEs were hyperprolactinaemia (57.7%) and injection site pain (32.8%).ConclusionsRisperidone-ISM achieved therapeutic levels from the first hours after drug administration and provided a sustained release throughout the 4-weeks dosing period over multiple intramuscular injections independently of the injection site. Risperidone-ISM was found to be safe and well tolerated.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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