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NCT ID: NCT01764997 Terminated - Clinical trials for Rheumatoid Arthritis

An Evaluation of Sarilumab Plus Methotrexate Compared to Etanercept Plus Methotrexate in RA Patients Not Responding to Adalimumab Plus Methotrexate

RA-COMPARE
Start date: April 2013
Phase: Phase 3
Study type: Interventional

Primary Objective: To demonstrate the treatment effect of sarilumab and methotrexate (MTX) compared to etanercept and methotrexate (MTX) in patients with rheumatoid arthritis (RA) and an inadequate response to adalimumab and methotrexate by evaluation of the Disease Activity Score for 28 joints (DAS28). Secondary Objectives: To assess the signs and symptoms of rheumatoid arthritis (RA) in patients taking sarilumab in combination with methotrexate (MTX). To assess the quality of life of patients with rheumatoid arthritis (RA) taking sarilumab in combination with methotrexate (MTX). To assess the safety and tolerability of sarilumab in combination with methotrexate (MTX) in patients with rheumatoid arthritis (RA).

NCT ID: NCT01760057 Completed - HIV Testing Clinical Trials

Evaluating the Effect of a Novel Web-based Intervention to Increase HIV Testing in Men Who Have Sex With Men

TuNexo
Start date: January 2013
Phase: N/A
Study type: Interventional

The proposed study is designed to develop and test the effectiveness of a novel web-based HIV intervention to motivate HIV testing among men who have sex with men (MSM). The intervention arm includes the delivery of videos tailored to the reasons MSM have for not getting tested for HIV, as well as HIV testing motivational messages sent via mobile-phone text messaging, e-mail or instant messaging. The intervention and assessments will be guided by the Information-Motivation-Behavioral skills model, the Health Belief Model and the Stages of Change theory. The control intervention will be a health promotion message (similar in content to other Peruvian websites) with an invitation for free HIV testing. Testing will be offered at the Via Libre and Epicentro clinic, and at a mobile unit whose location will be determined based on participants' demand. The outcomes evaluated will be intention to get tested and actual HIV testing among MSM of each of the trial arms.

NCT ID: NCT01753193 Completed - Clinical trials for Lupus Erythematosus, Systemic

An Open-label Study to Evaluate the Long-term Safety of MEDI-546, for the Treatment of SLE, in Adults

Start date: March 28, 2013
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the long-term safety of anifrolumab (MEDI-546) in adults with moderate to severe active systemic lupus erythematosus (SLE).

NCT ID: NCT01750190 Completed - CKD Anemia Clinical Trials

A Study of Roxadustat for the Treatment of Anemia in Participants With Chronic Kidney Disease and Not Receiving Dialysis

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

The purpose of this study is to determine whether roxadustat is safe and effective in the treatment of anemia in participants with chronic kidney disease and not on dialysis.

NCT ID: NCT01748929 Completed - Clinical trials for Intestinal Diseases, Parasitic

Postpartum Deworming: Improving Breastfeeding and Optimizing Infant Growth

Start date: February 24, 2014
Phase: Phase 4
Study type: Interventional

Women of reproductive age are considered a high-risk group for worm infections by the World Health Organization. Maternal infection and anemia contribute to infant malnutrition by affecting milk quality and quantity, and duration of exclusive breastfeeding. To date, no study has investigated the health benefits of postpartum deworming to infants or mothers. A randomized controlled trial will be conducted in Peru to investigate the effectiveness of integrating deworming into routine postpartum care. The primary measure of effect will be infant weight gain between birth and six months of age. Other infant and maternal health indicators will also be ascertained.

NCT ID: NCT01741688 Completed - Clinical trials for Rheumatoid Arthritis

An Observational Study of Tocilizumab (Actemra) in Patients With Moderate to Severe Rheumatoid Arthritis

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

This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab (Actemra) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on tocilizumab treatment in accordance with the local label were followed for 6 months.

NCT ID: NCT01724021 Completed - Clinical trials for Diffuse Large B-Cell Lymphoma, Non-Hodgkin's Lymphoma

A Study of Participant Preference With Subcutaneous Versus Intravenous MabThera/Rituxan in Participants With CD20+ Diffuse Large B-Cell Lymphoma or CD20+ Follicular Non-Hodgkin's Lymphoma Grades 1, 2 or 3a

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

This multi-center, open-label, randomized study will evaluate the participant preference with subcutaneous versus intravenous administration of MabThera/Rituxan (rituximab) in participants with CD20+ diffuse large B-cell lymphoma or CD20+ follicular non-Hodgkin's lymphoma. In Arm A, participants will receive MabThera/Rituxan 375 mg/m2 intravenously (IV) on Day 1 of Cycle 1 and MabThera/Rituxan 1400 mg subcutaneously (SC) on Day 1 of Cycles 2-4, followed by MabThera/Rituxan IV in Cycles 5-8. Participants in Arm B will receive MabThera/Rituxan IV in Cycles 1-4 and SC in Cycles 5-8. All participants will receive 6-8 cycles of standard chemotherapy (according to local country practice) with 8 cycles of MabThera/Rituxan. Anticipated time on study treatment is up to 24 weeks.

NCT ID: NCT01720654 Completed - Gonorrhea Clinical Trials

Expedited Partner Therapy for MSM in Peru

Start date: August 2012
Phase: N/A
Study type: Interventional

Expedited Partner Therapy (EPT) has been shown to reduce rates of persistent or recurrent gonorrhea and chlamydia infection in heterosexual patients, but has not been evaluated for use among men who have sex with men (MSM). CDC guidelines support the use of EPT for partner management with heterosexual patients, but note the absence of evidence necessary to make an equivalent recommendation for the use of EPT with MSM. Randomized clinical trials to assess the impact of EPT on partner notification, treatment, and STI re-infection among MSM are critical to the development of evidence-based partner management guidelines. Recent data from urban Peru has identified prevalences of rectal and pharyngeal gonorrhea and chlamydia ranging from 5-20%. The elevated burden of disease among MSM in Peru suggests that frequent transmission of undiagnosed gonorrhea and chlamydia through MSM sexual networks may be a factor contributing to the persistently high incidence of HIV infection among MSM in the region. The investigators propose a pilot evaluation of the effect of EPT on partner notification and treatment among MSM in Peru diagnosed with gonorrhea or chlamydia at any anatomic site. Specific Aim 1: To explore the social norms and structural factors influencing partner notification and treatment among MSM in Peru. Specific Aim 2: To determine the effect of EPT on anticipated and actual partner notification among MSM diagnosed with gonorrhea or chlamydia infection. Specific Aim 3: To develop preliminary data on rates of gonococcal and chlamydial re-infection among MSM randomized to receive EPT compared with standard partner notification counseling. The proposed study will provide pilot data on the use of EPT with MSM diagnosed with gonorrhea or chlamydia and form the basis for a subsequent Phase III clinical trial of EPT as an STI control method among MSM in Latin America.

NCT ID: NCT01720641 Completed - Clinical trials for Partner Notification Following STI Diagnosis

Partner Notification Strategies for MSM in Peru

Start date: August 2012
Phase: N/A
Study type: Interventional

The goal of the proposed research is to assess new strategies for partner management and sexually transmitted infection (STI) control to reduce the spread of HIV-1 among men who have sex with men (MSM) in Latin America. The HIV epidemic in Peru remains concentrated within the core risk group of MSM. STI infection and re-infection are central to the continuation of the HIV epidemic among MSM in Peru. Development of improved strategies for partner notification and treatment will reduce the incidence and prevalence of STIs and ultimately reduce the incidence of HIV infection in this population. The first phase of this study used qualitative methods to explore attitudes and practices related to partner notification among MSM in Lima, Peru. Findings from the qualitative research were used to develop a quantitative survey instrument to assess partner notification decision-making processes and practices among MSM in Peru recently diagnosed with HIV or syphilis infection. Data from both quantitative and qualitative phases of the study have been used to develop a partner notification for MSM in Peru. Investigators plan to implement and assess the impact of the intervention on rates of partner notification following a diagnosis of syphilis among MSM in Lima, Peru. The investigators hypothesize that participants randomized to receive one or more partner notification tools will report a higher frequency of partner notification.

NCT ID: NCT01719003 Completed - Clinical trials for Diabetes Mellitus, Type 2

Safety and Efficacy Study of Empagliflozin and Metformin for 24 Weeks in Treatment Naive Patients With Type 2 Diabetes

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

This study will investigate the efficacy and safety of two doses (high and low) of empagliflozin in combination with metformin (500 mg and 1000 mg) administered twice daily in patients with type 2 diabetes mellitus (T2DM). Study will compare four dose combinations of empagliflozin + metformin versus each individual component after 24 weeks of treatment.