scholarly journals Safety and Efficacy from an 8 Week Double-Blind Trial and a 26 Week Open-Label Extension of Asenapine in Adolescents with Schizophrenia

2015 ◽  
Vol 25 (5) ◽  
pp. 384-396 ◽  
Author(s):  
Robert L. Findling ◽  
Ronald P. Landbloom ◽  
Mary Mackle ◽  
Wendi Pallozzi ◽  
Sabine Braat ◽  
...  
Keyword(s):  
Double Blind Trial ◽  
Open Label ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Blind Trial ◽  
Open Label Extension

Valproate Therapy for Agitation in Dementia: Open-Label Extension of a Double-Blind Trial

2003 ◽  
Vol 11 (4) ◽  
pp. 434-440 ◽  
Author(s):  
Anton P. Porsteinsson ◽  
Pierre N. Tariot ◽  
Laura J. Jakimovich ◽  
Nancy Kowalski ◽  
Connie Holt ◽  
...  
Keyword(s):  
Double Blind Trial ◽  
Open Label ◽  
Double Blind ◽  
Blind Trial ◽  
Open Label Extension

Randomised double blind trial of the safety and efficacy of two gadolinium complexes (Gd-DTPA and Gd-DOTA)

1994 ◽  
Vol 36 (1) ◽  
pp. 27-30 ◽  
Author(s):  
P. Brugiores ◽  
A. Gaston ◽  
H. R. Degryse ◽  
P. M. Parizel ◽  
A. M. de Schepper ◽  
...  
Keyword(s):  
Double Blind Trial ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Blind Trial ◽  
Gadolinium Complexes

scholarly journals Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial

2021 ◽  
Vol 20 (1) ◽  
pp. 38-48 ◽  
Author(s):  
Bardia Nourbakhsh ◽  
Nisha Revirajan ◽  
Bridget Morris ◽  
Christian Cordano ◽  
Jennifer Creasman ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Double Blind Trial ◽  
Double Blind ◽  
Safety And Efficacy ◽  
Blind Trial

scholarly journals Longterm Safety and Efficacy of Subcutaneous Tocilizumab Monotherapy: Results from the 2-year Open-label Extension of the MUSASHI Study

2015 ◽  
Vol 42 (5) ◽  
pp. 799-809 ◽  
Author(s):  
Atsushi Ogata ◽  
Koichi Amano ◽  
Hiroaki Dobashi ◽  
Masayuki Inoo ◽  
Tomonori Ishii ◽  
...  
Keyword(s):  
Adverse Events ◽  
Disease Activity ◽  
Additional Treatment ◽  
Joint Disease ◽  
Open Label ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Safety And Efficacy ◽  
American College Of Rheumatology ◽  
Open Label Extension

Objective.To evaluate the longterm safety and efficacy of subcutaneous tocilizumab (TCZ-SC) as monotherapy in patients with rheumatoid arthritis (RA).Methods.Of 346 patients who received 24 weeks of double-blind treatment with either TCZ-SC monotherapy, 162 mg every 2 weeks (q2w); or intravenous TCZ (TCZ-IV) monotherapy, 8 mg/kg every 4 weeks; 319 patients continued to receive TCZ-SC q2w in the 84-week open-label extension (OLE) of the MUSASHI study (JAPICCTI-101117). Efficacy, safety, and immunogenicity were evaluated for all patients treated with TCZ during 108 weeks.Results.The proportions of patients who achieved American College of Rheumatology 20/50/70 responses, low disease activity [28-joint Disease Activity Score (DAS28) ≤ 3.2], or remission (DAS28 < 2.6) at Week 24 were maintained until Week 108. The incidences of adverse events and serious adverse events were 498.3 and 16.9 per 100 patient-years (PY), respectively. The overall safety of TCZ-SC monotherapy was similar to that of TCZ-IV monotherapy. Rates of injection site reactions (ISR) through 108 weeks remained similar to rates through 24 weeks. ISR were mild and did not cause any patient withdrawals. No serious hypersensitivity events (including anaphylactic reactions) occurred. Anti-TCZ antibodies were present in 2.1% of patients treated with TCZ-SC monotherapy.Conclusion.TCZ-SC monotherapy maintained a favorable safety profile and consistent efficacy throughout the 108-week study. Like TCZ-IV, TCZ-SC could provide an additional treatment option for patients with RA.

Sign in / Sign up

Export Citation Format

Share Document