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NCT ID: NCT01212757 Completed - Psoriatic Arthritis Clinical Trials

PALACE 2: Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

PALACE2
Start date: September 27, 2010
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis. Apremilast is proposed to improve signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

NCT ID: NCT01211470 Completed - Clinical trials for Acute Bacterial Skin and Skin-structure Infection(ABSSSI) Due to Staphylococcus Aureus (MSSA)

Initial Treatment for Acute Bacterial Skin Infections (ABSSSI) Caused by Staphylococcus Aureus

Start date: October 2010
Phase: Phase 2
Study type: Interventional

The study investigates the safety and efficacy of PMX-30063 in patients treated for acute bacterial skin and skin-structure infection (ABSSSI).

NCT ID: NCT01211249 Completed - Clinical trials for Rheumatoid Arthritis

GLPG0259 in Methotrexate-refractory Rheumatoid Arthritis

Start date: October 2010
Phase: Phase 2
Study type: Interventional

Part A: 30 patients suffering from active rheumatoid arthritis despite continued treatment with methotrexate will receive once daily two capsules containing either GLPG0259 (25 mg/capsule) or matching placebo, for 12 weeks. In the course of the study the patients will be examined for severity of disease, as well as for any adverse effects that may occur. If needed, dosing may be split to one capsule twice daily, or reduced to one capsule of 25 mg. Part B: If results of Part A suggest test medication to have a therapeutic advantage over placebo and to be well-tolerated, more patients will be recruited for Part B, where various dosages will be assessed. These dosages will be established based on results from Part A.

NCT ID: NCT01208194 Completed - Clinical trials for Advanced Colorectal Carcinoma

Efficacy Study of a Maintenance Therapy With Immunomodulator MGN1703 in Patients With Advanced Colorectal Carcinoma

IMPACT
Start date: June 2010
Phase: Phase 2
Study type: Interventional

This is a phase 2, randomized, double-blind, multi-center clinical study to evaluate efficacy and safety of a maintenance therapy with the immunomodulator MGN1703 compared to placebo control. The study will be conducted in patients with advanced colorectal carcinoma (AJCC Stage IV) with disease control after first-line standard chemotherapy regimens.

NCT ID: NCT01208090 Completed - Psoriasis Clinical Trials

ACT-128800 in Patients With Moderate to Severe Chronic Plaque Psoriasis

Start date: October 31, 2010
Phase: Phase 2
Study type: Interventional

This study will assess the efficacy, safety and tolerability of two doses of ACT 128800 in patients with moderate-to-severe chronic plaque psoriasis.

NCT ID: NCT01207648 Completed - Multiple Sclerosis Clinical Trials

Retrospective Cohort Study of Rebif® Use in Pediatric Multiple Sclerosis (MS) Subjects (REPLAY)

REPLAY
Start date: July 2010
Phase: N/A
Study type: Observational

The aim of this retrospective study is to review and describe safety, tolerability and efficacy of Rebif® (subcutaneous interferon [IFN]-beta-1a) in children and adolescents, using information already recorded in medical records. The study duration is 13 July 2010 (first data collected) to 13 July 2011 (last data collected). In this study, Data of the subjects evaluated between 1997 and 2009 was observed.

NCT ID: NCT01207583 Completed - Clinical trials for Healthy Children After Vaccination

Prevenar (PCV-7) Post-Licensure Safety Study In Russia

Start date: December 2009
Phase: N/A
Study type: Observational

This study is planned to monitor the local and/or systemic reactions and compatibility of PCV-7 with routine vaccines in the Russian National immunization schedule. Consistent with the observational nature of this protocol, Prevenar will be administered as standard of care. The aim of this study is to estimate the incidence of febrile reactions more than 38.0 degrees Celsius, specifically (≥38 to < 39 degrees C; > 39 to < 40 degrees C and > 40 degrees C, and the frequency of other local or systemic reactions following vaccination with Prevenar (PCV-7) co-administered with other routine childhood vaccines under the conditions of routine daily use in the Russian Federation.

NCT ID: NCT01207388 Completed - Clinical trials for B-cell Acute Lymphoblastic Leukemia

Confirmatory Phase II Study of Blinatumomab (MT103) in Patients With Minimal Residual Disease of B-precursor Acute Lymphoblastic Leukemia (ALL)

BLAST
Start date: November 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to confirm whether the bispecific T cell engager blinatumomab (MT103) is effective, safe and tolerable in the treatment of ALL patients with minimal residual disease.

NCT ID: NCT01206764 Completed - Clinical trials for Renal Cell Carcinoma

A Trial of Everolimis in Patients With Advanced Renal Cell Carcinoma.

Start date: November 11, 2009
Phase: Phase 4
Study type: Interventional

Renal cell carcinoma (RCC) accounts for more than 200,000 new cases of cancer and over 100,000 cancer deaths annually in the World (Ferlay, et al., 2004). It is estimated that there were about 15,000 new cases of RCC in the region that excludes the Americas, European Union and Japan. Renal cell carcinomas arise from the proximal tubal epithelium are more common in males than in females with an overall lifetime risk of 1 in 75 and a median age of diagnosis of 65 years. Everolimus (Certican®) has been approved since 2003 in more than 60 countries for the prevention of organ rejection in patients with renal and cardiac transplantation. Everolimus (RAD001) is a derivative of rapamycin, which acts as a signal transduction inhibitor. It targets mTOR, a key protein kinase regulating cell growth, proliferation, and survival. The mTOR pathway activity is modulated by the phosphatidylinositol-3-kinase (PI3K)/protein kinase B AKT (AKT) pathway, a pathway known to be deregulated in numerous human cancers. RAD001 (Afinitor®) has been investigated as an anticancer agent based on its potential to act: - directly on the tumor cells by inhibiting tumor cell growth and proliferation; - indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell hypoxia-inducible factor 1 (HIF-1) activity, VEGF production, and VEGF-induced proliferation of endothelial cells). Primary: To evaluate the PFS rate over time. Secondary: - To evaluate the disease control rate (stable disease [SD] + partial response [PR] + complete response [CR]); - To evaluate the objective response rate (ORR; where ORR = CR + PR) and duration; - To describe the safety profile of RAD001.

NCT ID: NCT01205737 Completed - DLBCL Clinical Trials

A Double-blind, Randomized Controlled Study in CD20-positive Diffuse B Cell Non-Hodgkin's Lymphoma Subjects

Start date: September 2010
Phase: Phase 1
Study type: Interventional

This is a prospective international, multi-center, randomized, double-blind controlled study designed to assess and compare the pharmacokinetics, pharmacodynamics and the safety of MabThera® and TL011, in combination with CHOP in previously untreated patients with diffuse large B cell lymphoma.