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NCT ID: NCT05814627 Recruiting - Clinical trials for Rheumatoid Arthritis

Study to Assess Change in Disease Activity and Adverse Events of Oral Upadacitinib Compared to Subcutaneous Adalimumab in Adult Participants With Moderate to Severe Rheumatoid Arthritis

SELECT- SWITCH
Start date: June 15, 2023
Phase: Phase 3
Study type: Interventional

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. This study will assess how safe and effective upadacitinib is in treating RA when compared to adalimumab in adult participants with inadequate response or intolerance to one TNF-inhibitor who are on a stable dose of methotrexate (MTX). Adverse events and change in disease activity will be assessed. Upadacitinib is an approved drug for the treatment of RA. This study is double-blinded means that neither the participants nor the study doctors will know who will be given upadacitinib and who will be given adalimumab. Study doctors put the participants in 1 of the 2 groups, called treatment arms randomly, to receive either upadacitinib or adalimumab. There is 1 in 2 chance that participants will receive adalimumab. Each group consists of 2 periods. Approximately 480 participants diagnosed with RA will be enrolled in approximately 250 sites across the world. Participants will receive the oral upadacitinib once daily and matching adalimumab placebo every other week, or the subcutaneous adalimumab every other week and matching upadacitinib placebo once daily during Period 1. Eligible participants will continue to receive same study treatment in Period 2 as assigned in Period 1 and will be followed for 30 days and 70 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

NCT ID: NCT05814536 Recruiting - Clinical trials for Solid Tumors With IDH1 Mutation

IDH1 Inhibitor AB-218 in Patients With Advanced IDH1 Mutant Cholangiocarcinoma and Other Solid Tumor

Start date: May 6, 2023
Phase: Phase 1
Study type: Interventional

This is an open label, single-arm Phase I study to evaluate the safety, tolerability, PK and preliminary efficacy of AB-218, an oral IDH1 inhibitor, for the treatment of adult patients with advanced IDH1 mutant cholangiocarcinoma and other solid tumors who have failed at least one prior therapy in the advanced stage. The study contains a dose escalation part and a dose expansion part. In the dose escalation part, participants are enrolled sequentially into one of 3 dose levels of AB-218 (125 mg BID, 250 mg BID and 500 mg BID) following a 3+3 rule. Intensive PK sampling will be performed during the dose escalation part. Participants will be followed up for DLTs from the date of first study dose to 28 days afterwards. When all participants in the dose escalation part have completed the 28-day DLT observation period, SMC will review the available data including but not limited to safety, tolerability and PK, and then recommend the dose for the study dose expansion part. In the dose expansion part, there are 2 disease cohorts planned: cholangiocarcinoma (CCA) and other IDH1 mutant solid tumors. It is planned to enrol 30 participants in the CCA cohort and another 15 participants in other IDH1 mutant solid tumors, to assess the safety and preliminary efficacy of AB-218. Sparse PK samples will be collected to further evaluate the PK profile in the different target populations. Each participant will undergo screening up to 28 days prior to the start of the treatment period. The treatment period consists of a visit on Day 1 of every 28-day cycle and continues until any of disease progression, unacceptable toxicity, withdrawal of consent or death. An end of treatment (or early discontinuation) visit occurs 30 days (± 7 days) after the last dose of study medication, and a survival follow call every 12 weeks until death, withdrawal of informed consent, loss to follow-up (LTFU) or termination of the study by the sponsor, whichever occurs first.

NCT ID: NCT05814354 Recruiting - Breast Cancer Clinical Trials

SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial

Start date: June 30, 2023
Phase: Phase 3
Study type: Interventional

The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.

NCT ID: NCT05814172 Recruiting - All-cause Mortality Clinical Trials

ADL and CONUT for Predicting 1-year Mortality Risk in Older Adults After Hip Fracture

Start date: October 2023
Phase:
Study type: Observational

Hip fracture has a serious impact on the quality of life and even the survival of older adults. The multidisciplinary management of hip fracture has been shown to be effective in improving patient outcome and cost-effective in international studies. As geriatricians and members of a multi-disciplinary team(MDT), we are aware of various scores in predicting the 1-year mortality risk in hospitalized older adults with multimorbidity. However, given the need for a deeper understanding of the preoperative status of elderly patients who were suffering from pain, tension, anxiety, delirium,etc., we hope to explore a simple, quick, objective, and accurate method for assessing the status of elderly patients with hip fractures to predict their survival risk.

NCT ID: NCT05813795 Active, not recruiting - Weight Management Clinical Trials

A Phase 3 Study to Evaluate the Efficacy of XW003 in Adults With Overweight or Obesity

Start date: April 5, 2023
Phase: Phase 3
Study type: Interventional

The aim of the study is to evaluate the efficacy and safety of XW003 versus placebo in adults with overweight or obesity

NCT ID: NCT05813704 Recruiting - Clinical trials for Chronic Total Occlusion of Coronary Artery

Coronary Crossing System in Patients With Coronary Chronic Total Occlusions

VITAL
Start date: November 7, 2023
Phase: N/A
Study type: Interventional

This is a prospective and multicenter clinical investigation aiming to evaluate the safety and effectiveness of coronary crossing system for the treatment of patients with coronary chronic total occlusions.

NCT ID: NCT05813665 Not yet recruiting - Clinical trials for Giant Cell Tumor of Bone

A Study to Evaluate the Efficacy and Safety of Narlumosbart (JMT103) in Patients With Giant Cell Tumor of Bone

Start date: April 2023
Phase: Phase 3
Study type: Interventional

This is a phase Ⅲ, multi-center, randomized, double-blind, active-controlled study to evaluate the efficacy and safety of narlumosbart (JMT103) in patients with unresectable or surgically difficult giant cell tumor of bone (GCTB). This clinical trial study hypothesizes narlumosbart administration groups are not inferior to active control administration groups.

NCT ID: NCT05813626 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

Neoadjuvant Chemotherapy Plus Toripalimab in Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Start date: April 3, 2023
Phase: Phase 2
Study type: Interventional

Neoadjuvant chemotherapy plus toripalimab in patients with locoregionally advanced nasopharyngeal carcinoma

NCT ID: NCT05813600 Completed - Clinical trials for Omicron Variant of COVID-19

Efficacy and Safety of Nirmatrelvir/Ritonavir for Treating Omicron Variant of COVID-19

Start date: August 2022
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to evaluate the efficacy and safety of Nirmatrelvir/Ritonavir in the treatment of the Omicron variant of COVID-19. The main question it aims to answer is: Whether the use of the drug can help patients recover from COVID-19. Patients in both groups were given Lianhua Qingwen Capsule orally, 3 times/day, 6 g/time. oral antipyretic (ibuprofen suspension 10ml) and symptomatic supportive treatment for body temperature >38.5 ℃. The study group was given Nirmatrelvir 300mg/Ritonavir 100mg orally, q12h, for 5 days, and the control group not given any antiviral drugs.

NCT ID: NCT05813587 Completed - Post-COVID-19 Clinical Trials

To Evaluate the Safety and Efficacy of Meplazumab in Treatment of Post-COVID-19

Start date: March 23, 2023
Phase: Phase 3
Study type: Interventional

This trial was a randomized, double-blind, placebo-controlled, loading phase III clinical study.