AN EXPLORATORY TRIAL TO ASSESS NATURALISTIC SAFETY AND EFFICACY OUTCOMES IN PATIENTS TRANSITIONED TO USTEKINUMAB FROM PREVIOUS METHOTREXATE THERAPY (TRANSIT) The primary objective of this exploratory trial is to evaluate the comparative safety through week 12 of two treatment transition strategies in patients with inadequate response to methotrexate: disco...

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Double-Blind, Placebo-Controlled, Multicenter Acute Study of Clinical Effectiveness of Nesiritide in Subjects with Decompensated Heart Failure The primary objective of this study is to evaluate whether treatment with nesiritide improves patient outcomes (as measured by reduction in the composite of HF rehospitalization and all-cause mortalit...

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A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of the Efficacy and Safety of Dapoxetine in Men With Premature Ejaculation and Concomitant Erectile Dysfunction Treated With a Phosphodiesterase-5 Inhibitor The primary objective is to determine the efficacy of dapoxetine (30/60 mg prn) compared with placebo after 12 weeks of treatment in prolonging IELT (intravaginal ejaculatory latency time) in men with...

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An efficacy and safety study of Telaprevir in patients with genotype 1 Hepatitis C infection after liver transplantation to determine the efficacy of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in genotype 1 chronic HCV infected liv...

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A Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of RWJ-333369 as Adjunctive Therapy in Subjects with Refractory Partial Seizures The primary objective of this study is to evaluate the efficacy, safety, and tolerability of 4 daily doses of RWJ-333369 (100, 300, 800, and 1,600 mg) as adjunctive treatment of refractory partial epi...

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A Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adult and Elderly Hospitalized Participants With Influenza A Infection The primary objective is to evaluate the pharmacokinetic (PK) parameters of JNJ-63623872 in combination with oseltamivir in elderly subjects (aged 65 to ≤85 years) compared to adults (aged 18 to ≤64 y...

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An Efficacy Study for Epoetin alfa in Anemic Patients with Myelodysplastic Syndromes To demonstrate that epoetin alfa treatment is better at improving anemia outcome (as evaluated by Erythroid response – International Working Group [IWG] 2006) in subjects with International Prognostic...

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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effect of JNJ-16269110 on Hepatic Triglyceride Content in Obese Subjects To investigate mean changes in Hepatic Triglyceride Content (HTGC) from baseline to week 6 and 12 by 1H-Magnetic Resonance Spectroscopy (MRS) in obese subjects treated with JNJ-16269110: 10 mg bid, 1...

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A Proof-of Concept Study to Separately Study Talacotuzumab or Daratumumab in Low-Risk Intermediate-1 Risk Myelodysplastic Syndromes (MDS) patients The primary objective of the study is to evaluate the efficacy (transfusion independence [TI]) of talacotuzumab (JNJ-56022473) or daratumumab in transfusion-dependent subjects with low or intermediate...

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A Randomized, Multicenter, Open-Label, Study of Alimta® (pemetrexed) plus VELCADE® (bortezomib) or Alimta Alone or VELCADE alone in Subjects with Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Prior Antineoplastic Therapy Establish the objective tumor response rate (CR + PR) following treatment with VELCADE plus Alimta or Alimta alone or VELCADE alone in subjects with locally advanced or metastatic NSCLC who have faile...

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