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NCT ID: NCT01316939 Terminated - Crohn's Disease Clinical Trials

GSK1605786A in the Maintenance of Remission in Subjects With Crohn's Disease

SHIELD-2
Start date: May 2011
Phase: Phase 3
Study type: Interventional

A randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of two doses (500 mg once daily and 500 mg twice daily) of GSK1605786A in maintaining remission over 52 weeks in adult subjects with Crohn's disease. Efficacy will be assessed by the Crohn's Disease Activity Index (CDAI) score. Eligible subjects will have achieved response (CDAI decrease of at least 100 points) and/or remission (CDAI less than 150) in a prior GSK sponsored induction study. The primary endpoint will be proportion of subjects in remission at both Weeks 28 and 52. Safety will be assessed by recording of adverse events, clinical laboratory parameters including liver function tests, vital signs and electrocardiogram. Population pharmacokinetics will evaluate the two doses of GSK1605786A. Health outcomes assessments will include changes in Inflammatory Bowel Disease Questionnaire (IBDQ), SF-36v2, EQ-5D, Work Productivity and Activity Impairment - Crohn's Disease (WPAI-CD) and disability.

NCT ID: NCT01307800 Terminated - Schizophrenia Clinical Trials

A Study of LY2140023 in Patients With Schizophrenia

Start date: March 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether at least 1 dose level of LY2140023 given to acutely ill patients with schizophrenia will demonstrate significantly greater efficacy as compared to placebo.

NCT ID: NCT01290887 Terminated - Eosinophilic Asthma Clinical Trials

Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Reslizumab (3.0 mg/kg) as Treatment for Patients (12 Through 75 Years of Age) With Eosinophilic Asthma

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The primary objective of the study is to evaluate the long-term safety of reslizumab at a dosage of 3.0 mg/kg every 4 weeks for approximately 24 months in pediatric and adult patients with eosinophilic asthma as assessed by adverse events, physical examination findings, vital sign measurements, and concomitant medication usage throughout the study (every 4 weeks), clinical laboratory test results, and measurement of antidrug antibodies.

NCT ID: NCT01285557 Terminated - Clinical trials for Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction

Diffuse Gastric and Esophagogastric Junction Cancer S-1 Trial

DIGEST
Start date: April 14, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of S-1 and Cisplatin compared to 5-FU and Cisplatin in treatment of patients with metastatic diffuse gastric and gastro-esophageal junction cancer previously untreated with chemotherapy.

NCT ID: NCT01265381 Terminated - Thyroid Cancer Clinical Trials

Thyroid Cancer Among Chornobyl Clean-up Workers in Ukraine: Pilot Study

Start date: December 22, 2010
Phase:
Study type: Observational

Background: - The Ukrainian Research Center for Radiation Medicine and the U.S. National Institutes of Health have been studying cancer risks and outcomes in individuals who participated in the decontamination clean-up process following the Chornobyl nuclear accident. Some of these individuals were exposed to external radiation at various levels, as well as radioactive iodine that may have affected the thyroid and increased the risk of developing thyroid cancer. Because more individual and comparative data are needed on the affected populations and clean-up workers associated with the Chornobyl accident, researchers are interested in collecting personal information and saliva samples from Chornobyl clean-up workers who have been diagnosed with thyroid cancer. Objectives: - To assess the radiation-related risk of thyroid cancer among male Chornobyl clean-up workers and collect saliva samples for an initial study. Eligibility: - Male Chornobyl clean-up workers from Kyiv and Donetsk oblasts who have been diagnosed with thyroid cancer. Design: - Participants will complete a standardized questionnaire during a personal interview. The questionnaire will ask for detailed information on the following areas of study: - Work history, conditions, and activities inside the 70-km clean-up and radiation calculation zone. - Residence history inside and outside the 30-km exclusion zone. - Milk consumption between April 26 and June 30, 1986 (to assess radioactivity from radioiodine fallout). - Potential non-radiation risk factors for thyroid cancer (e.g., smoking, alcohol consumption, family cancer history). - Participants will provide a saliva sample for pilot study testing....

NCT ID: NCT01264770 Terminated - Clinical trials for Rheumatoid Arthritis

Evaluation of Efficacy and Safety of Fostamatinib Monotherapy Compared With Adalimumab Monotherapy in Patients With Rheumatoid Arthritis (RA)

OSKIRA -4
Start date: January 2011
Phase: Phase 2
Study type: Interventional

The purpose of the study is to evaluate the improvements in signs and symptoms of rheumatoid arthritis (RA) for fostamatinib compared to placebo or adalimumab in patients who are Disease-Modifying anti-rheumatic drug (DMARD) naïve, DMARD intolerant or have had an inadequate response to DMARDs. The study will last for approximately six months

NCT ID: NCT01242748 Terminated - Prostate Cancer Clinical Trials

A Degarelix Trial in Patients With Prostate Cancer

Start date: October 2010
Phase: Phase 3
Study type: Interventional

A phase III extension trial comparing the efficacy and safety of degarelix 3 month depot with the established therapy Zoladex 3 month implant in patients with prostate cancer.

NCT ID: NCT01242514 Terminated - Clinical trials for Rheumatoid Arthritis

Evaluation of Long-term Safety and Effectiveness of Fostamatinib in the Treatment of Rheumatoid Arthritis (RA)

OSKIRA-X
Start date: January 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients with rheumatoid arthritis (RA).

NCT ID: NCT01240694 Terminated - Clinical trials for Systemic Lupus Erythematosus

A Long-Term Study of the Safety and Tolerability of Repeated Administration of CEP-33457 in Participants With Systemic Lupus Erythematosus

Start date: December 9, 2010
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the long term safety and tolerability of repeated administration of subcutaneous (SC) CEP-33457 for injection every 4 weeks over 72 weeks (18 doses) in participants with systemic lupus erythematosus (SLE) who have participated in a previous Cephalon sponsored clinical study of CEP-33457, and completed at least Visit 8 (Week 24 of that study).

NCT ID: NCT01232556 Terminated - Clinical trials for Lymphoma, Non-Hodgkin

A Study Of Inotuzumab Ozogamicin Plus Rituximab For Relapsed/Refractory Aggressive Non-Hodgkin Lymphoma Patients Who Are Not Candidates For Intensive High-Dose Chemotherapy

Start date: April 4, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin plus rituximab in relapsed/refractory aggressive Non-Hodgkin lymphoma patients who are not candidates for intensive high-dose chemotherapy. Specifically, the goal is to demonstrate the superiority of this combination compared with an active comparator arm (investigator's choice of rituximab+bendamustine or rituximab+gemcitabine) using the primary endpoint of overall survival.