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NCT ID: NCT02011334 Completed - Clinical trials for Rheumatoid Arthritis

A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.

Start date: July 2014
Phase: Phase 3
Study type: Interventional

This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients in Latin America with an inadequate response to non-biologic DMARDs.

NCT ID: NCT02008916 Completed - Clinical trials for Spondylitis, Ankylosing

16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients

MEASURE 3
Start date: January 14, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year efficacy, safety and tolerability data in subjects with active AS despite current or previous NSAID, DMARD and/or anti-TNF therapy.

NCT ID: NCT02008344 Completed - Influenza Clinical Trials

Phase 3 Efficacy and Safety Study of Favipiravir for Treatment of Uncomplicated Influenza in Adults

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

The purpose of this study is to determine if favipiravir is effective in reducing the time to resolution of influenza symptoms.

NCT ID: NCT02008214 Not yet recruiting - HIV Infections Clinical Trials

Efficacy of PTX+IFN Alpha+ RBV on Hepatitis C Virus Coinfected HIV Patients

Start date: December 2013
Phase: Phase 4
Study type: Interventional

Current Hepatitis C virus (HCV) treatment consists of the combination of interferon alpha 2a (IFN-alpha 2a) plus ribavirin (RBV) and it provides sustained virologic responses (SVR) on 54 to 56% on HCV monoinfected patients and this response is even lower on HIV-HCV coinfected patients. A previous study on HCV monoinfected patients showed that the addition of pentoxyfylline (PTX) to a treatment scheme based on interferon-alfa and ribavirin increased SVR on 25%, although it is not known if the same effect is to be obtained in HCV-HIV coinfected patients. On the other hand, other factors such as host genetics, have proved to influence treatment response on HCV infected patients. The best described genetic factor so far is the interleukin 28B (IL28B) polymorphism rs12979860, where a cytosine-cytosine (CC) genotype provides an almost twice increase on SVR than the rest of the genotypes. Therefore, this is a randomized, double blind study to assess the efficacy of pentoxyfylline addition to a treatment scheme based on interferon-alfa and ribavirin in chronic HCV genotype 1, co-infected HIV-1 positive subjects, considering the IL28B polymorphism rs12979860. HIV-HCV coinfected subjects currently receiving Highly active antiretroviral therapy (HAART), with at least 8 months on undetectable HIV viral load and T helper cells count of 200 or higher will be included. Patients will be randomized on one of two groups: - Group A: IFN alpha 2a + RBV + PTX - Group B: IFN alpha 2a + RBV + placebo Patients will be followed for primary outcome during 72 (for rapid responders) or 96 weeks (for non rapid responses). Outcome measures will be the following: - SVR rate 24 weeks after the end of treatment - Grade of Hepatic fibrosis from baseline to the end of treatment, measured by transient elastography and the AST to platelet ratio index (APRI index) - IL28B rs12979860 genotype The study hypothesis is that the addition of PTX to a treatment scheme based on IFN-alfa2a and RBV in chronic HCV genotype 1, co-infected HIV-1 positive subjects will improve SVR rate and fibrosis progression irrespectively of IL28B rs12979860 genotype.

NCT ID: NCT02007174 Completed - Recurrent Pterygium Clinical Trials

Bevacizumab Injection for Recurrent Pterygium

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

Blockade of vascular endothelial growth factor (VEGF) with bevacizumab has been used to treat abnormal vascular conditions of the anterior segment of the eye. In pterygium, anti-VEGF agents have been recently proposed as primary treatments, such as perioperative adjuvants, as well as treatments for pterygia recurrences after surgery. The aim of the present study was to prospectively evaluate the effect of three subconjunctival bevacizumab injections in patients with an early pterygium recurrence. Materials and Methods: The current study was a non-randomized single central trial. The method of ensuring allocation concealment was sequentially numbered. Patients with an early pterygium recurrence were selected and invited to participate in the study. Recurrence was defined as the presence of corneal vessels with concomitant conjunctival hyperemia within the first trimester after primary pterygium removal, and only patients with primary pterygium recurrence were included. Patient related factors such as pregnancy, women seeking to become pregnant, and lactating women were excluded from the study. All patients received three subconjunctival bevacizumab (2.5 mg/0.05 ml) injections (basal, 2 and 4 weeks) in the recurrence area of the pterygium, and were photographed at the third, sixth and twelfth months after the last bevacizumab injection. Photographic analyses were performed taking into account two pterygium areas: the first measure included only the vessel area in the corneal surface, while the second measure included, both, conjunctival and corneal vessel area (corneal-conjunctival area of hyperemia). Neovascularization area of each pterygium was determined using digital slit lam pictures, which were analyzed using Photoshop CS4, in order to get pixels measurements of the lesion.

NCT ID: NCT02006654 Completed - Alzheimer's Disease Clinical Trials

Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With an Acetylcholinesterase Inhibitor

STARBRIGHT
Start date: March 2014
Phase: Phase 3
Study type: Interventional

To establish efficacy of idalopirdine as adjunctive therapy to acetylcholinesterase inhibitors (AChEIs) for symptomatic treatment of patients with mild-moderate Alzheimer's disease (AD).

NCT ID: NCT02002884 Completed - Cerebral Palsy Clinical Trials

Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy

XARA
Start date: March 28, 2014
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of one or both arms alone or in combination with injections into one or both legs are effective and safe in treating children/adolescents (age 2-17 years) with increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.

NCT ID: NCT02000622 Active, not recruiting - Clinical trials for Breast Cancer Metastatic

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

OlympiAD
Start date: March 27, 2014
Phase: Phase 3
Study type: Interventional

This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.

NCT ID: NCT01999192 Terminated - Clinical trials for Rheumatoid Arthritis

Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis

986
Start date: October 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone. The overall study duration is 24 weeks followed by a 24 week extension phase.

NCT ID: NCT01998880 Completed - Clinical trials for Lymphocytic Leukemia, Chronic

CLL11: A Study of Rituximab With Chlorambucil or Chlorambucil Alone in Patients With Previously Untreated Chronic Lymphocytic Leukemia (Stage 1b)

Start date: December 22, 2009
Phase: Phase 3
Study type: Interventional

This open-label, randomized, 3-arm study will evaluate the efficacy and safety of obinutuzumab (RO5072759) in combination with chlorambucil as compared to rituximab plus chlorambucil or chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL). Patients will be randomized 2:2:1 to receive a maximum of six 28-day cycles of either RO5072759 (1000mg iv infusion, on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-6) plus chlorambucil (0.5 mg/kg orally, days 1 and 15 of cycles 1-6), or rituximab (iv infusion day 1, 375 mg/m^2 cycle 1, 500 mg/m^2 cycles 2-6) plus chlorambucil, or chlorambucil alone. Anticipated time on study treatment is >6 months and follow-up for disease-progression and safety will be at least 5 years. In the US, this trial is sponsored/managed by Genentech.