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NCT ID: NCT01851707 Completed - Clinical trials for Rheumatoid Arthritis

A Double-Blind Study Evaluating Duvelisib in Subjects With Moderate to Severe Rheumatoid Arthritis and an Inadequate Response to Methotrexate Alone

ASPIRA
Start date: April 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate the safety and efficacy of multiple dose levels of the investigational product (study drug), IPI-145, in combination with methotrexate compared to methotrexate alone in subjects with active moderate-to-severe Rheumatoid Arthritis.

NCT ID: NCT01850615 Completed - Clinical trials for Diabetes Mellitus, Type 2

Efficacy and Safety of FIAsp in a Basal-bolus Regimen Versus Basal Insulin Therapy, Both in Combination With Metformin in Adult Subjects With Type 2 Diabetes

onset® 3
Start date: September 23, 2013
Phase: Phase 3
Study type: Interventional

This trial is conducted in Asia, Europe, South America, and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult subjects with type 2 diabetes.

NCT ID: NCT01844856 Completed - Clinical trials for Complicated Intra-abdominal Infections

Efficacy and Safety Study of Eravacycline Compared With Ertapenem in Complicated Intra-abdominal Infections

IGNITE1
Start date: August 2013
Phase: Phase 3
Study type: Interventional

This is a Phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy, safety, and pharmacokinetics of eravacycline compared with ertapenem in the treatment of adult complicated intra-abdominal infections (cIAI).

NCT ID: NCT01843374 Active, not recruiting - Clinical trials for Unresectable Pleural or Peritoneal Malignant Mesothelioma

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma

Tremelimumab
Start date: May 17, 2013
Phase: Phase 2
Study type: Interventional

This is a Phase 2b, randomized, double-blind, parallel-group study. Subjects with unresectable pleural or peritoneal malignant mesothelioma will be randomized in a 2:1 ratio to receive either tremelimumab or placebo. Approximately 564 subjects will be enrolled at study centers in multiple countries. The study consists of a screening period, a treatment period, a 90-day follow-up period for safety, and a long-term survival follow-up period.

NCT ID: NCT01838681 Completed - Clinical trials for Major Depressive Disorder

Brexpiprazole as Adjunctive Treatment in Patients With Major Depressive Disorder With an Inadequate Response to Antidepressant Treatment

Start date: June 2013
Phase: Phase 3
Study type: Interventional

To evaluate the maintenance of efficacy and safety during long-term treatment with brexpiprazole as an adjunctive treatment for adult subjects with Major Depressive Disorder (MDD)

NCT ID: NCT01836471 Completed - Asthma Clinical Trials

A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

Start date: May 2013
Phase: Phase 2
Study type: Interventional

The purpose of the study is to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

NCT ID: NCT01834742 Completed - Colorectal Cancer Clinical Trials

Pharmacodynamic Evaluation of Stool Output Following Oral Administration of Various Low Volume PEG3350-based Gut Cleansing Solutions Using the Split Dose Intake in Healthy Subjects

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

This study is to investigate the effect of various modified low volume polyethylene glycol (PEG) 3350 and ascorbic acid/ascorbate (PEG+ASC)-based gut cleansing solutions on stool output in healthy subjects. In addition, the study is to assess and compare the safety and tolerance of the modified PEG+ASC formulations following oral administration with the safety profile of MOVIPREP®.

NCT ID: NCT01834157 Recruiting - Arthritis Clinical Trials

Improvement of Hand Dysfunction by Arthritis in Systemic Sclerosis

Start date: April 2013
Phase: N/A
Study type: Observational [Patient Registry]

Systemic sclerosis (SSc) is an orphan, multiorgan disease affecting the connective tissue of the skin and several internal organs. Beside skin involvement, digital ulcers, tendinitis, calcinosis and flexion contractures, the presence of hand arthritis is a major contributor to impairment of hand function in systemic sclerosis. Several immunomodulatory drugs used in other rheumatic diseases (including methotrexate, leflunomide, azathioprine, mycophenolate mofetil and low-dose corticosteroids) can potentially improve arthritis and consequently hand function in systemic sclerosis. For the assessment of arthritis, the CDAI (clinical disease activity index) is validated in rheumatoid arthritis, and may be useful for SSc-related arthritis, too. This observational trial is part of the collaborative project "DeSScipher", one out of five observational trials to decipher the optimal management of systemic sclerosis. Aim of this observational trial is to: - investigate the efficacy and safety of different treatments on hand dysfunction in systemic sclerosis patients with hand arthritis and - to validate the CDAI for arthritis in systemic sclerosis.

NCT ID: NCT01831427 Completed - Ulcerative Colitis Clinical Trials

Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GS-5745 (Andecaliximab) in Adults With Moderate to Severe Active Ulcerative Colitis

Start date: March 28, 2013
Phase: Phase 1
Study type: Interventional

The primary objectives of this study are as follows: - To assess the safety and tolerability of escalating single and multiple doses of GS-5745 (andecaliximab) in participants with moderate to severe ulcerative colitis (UC) as assessed by adverse events (AEs) and laboratory abnormalities - To assess the pharmacokinetics (PK) of GS-5745 (andecaliximab) in participants with moderate to severe UC.

NCT ID: NCT01830543 Completed - Atrial Fibrillation Clinical Trials

A Study Exploring Two Strategies of Rivaroxaban (JNJ39039039; BAY-59-7939) and One of Oral Vitamin K Antagonist in Patients With Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention

PIONEER AF-PCI
Start date: May 10, 2013
Phase: Phase 3
Study type: Interventional

The primary purpose of this study is to evaluate the safety for 2 different rivaroxaban treatment strategies and one Vitamin K Antagonist (VKA) treatment strategy utilizing various combinations of dual antiplatelet therapy (DAPT) or low-dose aspirin (ASA) or clopidogrel (or prasugrel or ticagrelor).