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NCT ID: NCT01346488 Completed - Clinical trials for Rheumatoid Arthritis

Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)

Start date: June 2011
Phase: N/A
Study type: Observational

Study Objectives As special investigation (PMOS/non-mandatory) of HUMIRA® subcutaneous injection 40 mg syringe 0.8 mL (generic name: Adalimumab) will be performed to examine the following (1) and (2) for correlation between baseline and follow-up by clinical observation 48 weeks (planned visit time; before the start of treatment, and at 12, 24, 36, and 48 weeks, 4 data collection points) in Japanese rheumatoid arthritis patients who are engaged in paid work and home work. 1. The primary objective; Situation of work productivity using the Work Productivity and Activity Impairment/General Health questionnaire and functional impairment (daily life activity) using the Modified Health Assessment Questionnaire when HUMIRA® treatment. 2. The secondary objective; Clinical observation and rate of improvement of the Disease Activity Score 28 when HUMIRA® treatment. Situation of the occurrence of adverse events definition during the course of the observation period while HUMIRA® treatment, other factors considered to affect the safety and effectiveness.

NCT ID: NCT01345682 Completed - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 1: A Phase III Trial of Afatinib (BIBW2992) Versus Methotrexate for the Treatment of Recurrent and/or Metastatic (R/M) Head and Neck Squamous Cell Cancer After Platinum Based Chemotherapy

Start date: January 5, 2012
Phase: Phase 3
Study type: Interventional

This randomised, open-label, phase III study will be performed in patients with R/M head and neck squamous cell carcinoma (HNSCC) who have progressed after platinum-based therapy. The objectives of the trial are to compare the efficacy and safety of afatinib versus methotrexate

NCT ID: NCT01345669 Terminated - Clinical trials for Head and Neck Neoplasms

LUX-Head&Neck 2: A Phase III Trial of Afatinib (BIBW 2992) Versus Placebo for the Treatment of Head and Neck Squamous Cell Cancer After Treatment With Chemo-radiotherapy

Start date: October 17, 2011
Phase: Phase 3
Study type: Interventional

This randomised, double-blind phase III trial will be performed in patients with head and neck squamous cell carcinoma (HNSCC). The objectives of the trial are to compare the efficacy and safety of afatinib (BIBW 2992) with placebo as adjuvant therapy to patients who have received definitive chemo-radiotherapy.

NCT ID: NCT01345253 Completed - Clinical trials for Systemic Lupus Erythematosus

GSK1550188 A 52 Week Study of Belimumab Versus Placebo in the Treatment of Subjects With Systemic Lupus Erythematosus (SLE) Located in Northeast Asia

Start date: May 23, 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of belimumab in addition to standard therapy compared to placebo in subjects in Northeast Asia with systemic lupus erythematosus (SLE) over a 52 week period.

NCT ID: NCT01345019 Completed - Cancer Clinical Trials

Denosumab Compared to Zoledronic Acid in the Treatment of Bone Disease in Patients With Multiple Myeloma

Start date: May 17, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid in the treatment of bone disease from multiple myeloma.

NCT ID: NCT01344876 Completed - Multiple Myeloma Clinical Trials

Phase I Study of OPB-51602 in Patients With Hematologic Malignancies

Start date: April 2011
Phase: Phase 1
Study type: Interventional

To determine the maximum tolerated dose (MTD) of OPB-51602

NCT ID: NCT01344629 Completed - Healthy Clinical Trials

Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg FDC Tablet and Telmisartan 80 mg Tab and Amlodipine 5 mg Tab Concomitant Use

Start date: April 2011
Phase: Phase 1
Study type: Interventional

To investigate the bioequivalence of telmisartan administrated in two different ways: both in telmisartan 80 mg/amlodipine 5 mg fixed-dose combination tablets (T) and as telmisartan 80 mg tablet and amlodipine 5 mg tablets (R) in concomitant use

NCT ID: NCT01344304 Completed - Colorectal Cancer Clinical Trials

Study of Aprepitant / Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting (CINV) in Colorectal Cancer Patients - SENRI Trial

Start date: April 2011
Phase: N/A
Study type: Interventional

The object of this study is to evaluate the superiority of aprepitant therapy with a 5HT3-receptor antagonist, dexamethasone and aprepitant compared to standard therapy with a 5HT3-receptor antagonist and dexamethasone for prevention of nausea and vomiting in first course chemotherapy.

NCT ID: NCT01343888 Completed - Hepatitis C Clinical Trials

Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)

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

The objective of this trial is to evaluate the efficacy and safety of two different treatment regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care (SOC) with PegIFN/RBV alone.

NCT ID: NCT01343355 Active, not recruiting - Clinical trials for HTLV-I-Associated Myelopathy

Efficacy and Safety of Tamibarotene(AM80H) for HTLV-1 Associated Myelopathy/ Tropical Spastic Paraparesis (HAM/TSP)

Start date: January 2011
Phase: Phase 2/Phase 3
Study type: Interventional

An open-label, non-randomised, uncontrolled, proof-of-concept study of patients with HTLV-I-associated myelopathy/Tropical Spastic Paraparesis (HAM/TSP). Participants will receive oral administration of tamibarotene in the amount of 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks. The patients will be followed up for further 8 weeks. Efficacy will be monitored by measuring clinical scores including motor and urination function, HTLV-1 proviral load, immunological parameters, and markers in the spinal fluid. Safety will be evaluated at the same time.