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NCT ID: NCT01544595 Completed - Clinical trials for Moderate to Severe Plaque-type Psoriasis

Extension Study of Secukinumab Prefilled Syringes in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Completing Preceding Psoriasis Phase III Studies With Secukinumab

Start date: June 19, 2012
Phase: Phase 3
Study type: Interventional

This was an extension study of secukinumab prefilled syringes in subjects with moderate to severe chronic plaque-type psoriasis completing preceding psoriasis phase III studies with secukinumab. Subjects on secukinumab at the end of treatment period in phase III studies (e.g., ongoing CAIN457A2302 and CAIN457A2303 and potentially other secukinumab phase III studies) were eligible to join this extension study. This extension study was planned to collect an additional 2 years of long-term efficacy, safety, and tolerability data of secukinumab in either continuous or interrupted therapy (randomized withdrawal period) in subjects showing at least partial response to secukinumab and completing treatment period on secukinumab in previous phase III studies. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab were used.

NCT ID: NCT01544543 Completed - Clinical trials for Chronic Obstructive Pulmonary Disease

Validation of HealthCare Standards in Chronic Obstructive Pulmonary Disease

VESALIO
Start date: February 2010
Phase: N/A
Study type: Observational

VESALIO is a pilot study aimed at evaluating the feasibility and reliability (time stability and interobserver reliability) of healthcare quality standards in chronic obstructive pulmonary disease (COPD) recently outlined by SEPAR (Spanish Pneumology and Thoracic Surgery Society), and at establishing the foundation for a future validation (construct and criterion validation) of the aforementioned standards.

NCT ID: NCT01544491 Completed - Clinical trials for Prevention of Acute Rejection in Paediatric Recipients of a Renal Transplant

Efficacy, Tolerability and Safety of Early Introduction of Everolimus, Reduced Calcineurin Inhibitors and Early Steroid Elimination Compared to Standard CNI, Mycophenolate Mofetil and Steroid Regimen in Paediatric Renal Transplant Recipients

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

The purpose of this study is to determine if everolimus combined with reduced exposure CNI (TAC) is efficacious and safe and will support corticosteroid elimination compared to a standard exposure CNI (TAC) + MMF + steroid regimen after paediatric kidney transplantation. An additional purpose of the study is to assess the effect of the combination of EVR and reduced exposure CNI (TAC) on renal function. This study is part of the requirements of the Paediatric Investigational Plan approved by Paediatric Committee at the European Medicines Agency (PDCO/EMA) on September 10, 2010, and is intended to support the indication of everolimus in the prevention of acute rejection in paediatric recipients of a renal transplant.

NCT ID: NCT01544179 Completed - Clinical trials for Non-Small Cell Lung Cancer

A Study of IRESSA Treatment Beyond Progression in Addition to Chemotherapy Versus Chemotherapy Alone

IMPRESS
Start date: March 15, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of gefitinib in patients who have progressed on first line gefitinib, comparing continuing gefitinib in addition to cisplatin plus pemetrexed combination chemotherapy versus cisplatin plus pemetrexed combination chemotherapy alone.

NCT ID: NCT01543919 Completed - Clinical trials for Pulmonary Disease, Chronic Obstructive

Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Tiotropium Bromide

Start date: April 2012
Phase: Phase 2
Study type: Interventional

PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT01543698 Completed - Clinical trials for Solid Tumors Harboring a BRAF V600 Mutation

A Phase Ib/II Study of LGX818 in Combination With MEK162 in Adult Patients With BRAF Dependent Advanced Solid Tumors

Start date: May 28, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, open-label, dose finding, Phase Ib dose escalation study to estimate the MTD(s) and/or RP2D(s) for the dual combination of LGX818 and MEK162 and the triple combination of LGX818 and MEK162 and LEE011, followed each independently by a Phase II part to assess the clinical efficacy and to further assess the safety of the combinations in selected patient populations. Oral LGX818 and MEK162 will be administered on a continuous schedule. Oral LEE011 will be administered once daily on a three weeks on, one week off schedule. Patients will be treated until progression of disease, unacceptable toxicity develops, or withdrawal of informed consent, whichever occurs first. A cycle is defined as 28 days. The dose escalation parts of the trial will be conducted in adult patients with BRAF V600-dependent advanced solid tumors and is expected to enroll at least 18 patients for the dual combination and at least 12 patients for the triple combination. The dose escalation will be guided by a Bayesian logistic regression model (BLRM). Following MTD/RP2D declaration, patients will be enrolled in three Phase II arms for the dual combination and one Phase II arm for the triple combination. All patients will be followed for 30 days for safety assessments after study drugs discontinuation. All patients enrolled in the Phase II part of the study will be followed for survival.

NCT ID: NCT01543503 Completed - Clinical trials for Rheumatoid Arthritis

An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

Start date: February 2012
Phase: N/A
Study type: Observational

This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

NCT ID: NCT01543477 Completed - Pregnancy Clinical Trials

Post-Authorisation Safety Cohort Observation of RetacritTM (Epoetin Zeta) Administered Subcutaneously for the Treatment of Renal Anaemia

PASCO II
Start date: July 7, 2010
Phase:
Study type: Observational

The purpose of this study is to estimate the incidence of Pure Red Cell Aplasia (PRCA), neutralising antibodies, lack of efficacy, and thromboembolic events under treatment with Retacritâ„¢ (epoetin zeta) administered subcutaneously in patients with renal anaemia. The other key objective of this study is to obtain information on adverse drug reactions (ADR) associated with Retacritâ„¢ (epoetin zeta), use of epoetin zeta during pregnancy and lactation and data on long term use.

NCT ID: NCT01542957 Completed - Clinical trials for Major Depressive Disorder

Cognitive Therapy for Unipolar Depression: Efficacy of a Dilemma-Focused Intervention

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

The purpose of this study is to determine the efficacy of a brief psychological intervention focused on the personal dilemmas identified for each depressive patient. For that, this intervention is combined to group cognitive therapy (an already proven efficacious format) and compared to cognitive individual therapy.

NCT ID: NCT01541605 Completed - Mania Clinical Trials

Methylphenidate for the Treatment of Acute Mania

Start date: March 2012
Phase: Phase 3
Study type: Interventional

This study aims at evaluating the efficacy and safety of methylphenidate in the initial treatment of acute mania in patients with bipolar affective disorders.