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NCT ID: NCT03980483 Completed - Clinical trials for Arthritis, Rheumatoid

Efficacy and Safety of GSK3196165 Versus Placebo and Tofacitinib in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

contRAst 1
Start date: May 16, 2019
Phase: Phase 3
Study type: Interventional

This study [contRAst 1 (201790: NCT03980483)] is a phase 3, randomized, multicenter, double blind study to assess the safety and efficacy of GSK3196165, in combination with methotrexate (MTX), for the treatment of adult participants with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to MTX. The study will consist of a screening phase of up to 6 weeks followed by a 52-week treatment phase in which participants will be randomized in a ratio of 6:6:3:1:1:1 to receive GSK3196165 150 milligrams (mg) subcutaneous (SC) weekly, GSK3196165 90 mg SC weekly, tofacitinib capsules (cap) 5 mg twice a day or placebo (three arms, each placebo arm will have 12 weeks placebo followed by 40 weeks active treatment) respectively, all in combination with MTX. Participants who, in investigator's judgement will benefit from extended treatment with GSK3196165, may be included in the long-term extension study [contRAst X (209564: NCT04333147)]. For those participants who do not continue into the long term-extension study, there will be an 8 week safety follow-up visit following the treatment phase.

NCT ID: NCT03979313 Completed - Clinical trials for Respiratory Syncytial Virus Infections

A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended Lower Respiratory Tract Infection Due to Respiratory Syncytial Virus in Healthy Late Preterm and Term Infants (MELODY)

MELODY
Start date: July 23, 2019
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first RSV season.

NCT ID: NCT03979053 Completed - Clinical trials for Autoimmune Hepatitis

Quantitative Magnetic Resonance Imaging to Aid Clinical Decision Making in Autoimmune Hepatitis.

Start date: June 26, 2019
Phase:
Study type: Observational

This will be a prospective, observational, cross-sectional study designed to assess how a quantitative Magnetic Resonance Imaging (MRI) scan will aid in a physicians' clinical decision making process in patients with suspected or confirmed Autoimmune Hepatitis (AIH). Participants will be recruited from the specialist outpatient hepatology clinic at Kings College Hospital NHS (National Health Service) Trust who are either being seen as a new or follow-up patient. Participants will be treated and assessed in line with the normal clinical care pathway. Autoimmune hepatitis is relatively rare, with a prevalence of about 8,000 people in the United Kingdom (UK) diagnosed. It is a non-resolving liver condition that is usually treated with a combination of corticosteroid and immunosuppressant therapy. The current standard for effective management requires close monitoring of disease activity to balance disease control and unwanted side effects of treatment . The recommended management involves monthly blood tests and annual liver biopsies to verify histological remission . However, blood tests lack sensitivity and biopsy is very invasive and samples only a small portion of the liver . Indeed, liver biopsy remains the gold standard for evaluating liver pathology, however it is not appropriate for longitudinal monitoring due to pain, risk and invasiveness. Blood tests can identify when the liver is inflamed, but are insensitive to small changes and are not prognostic. There is a significant unmet need in this patient group relating to both disease monitoring and identifying those needing higher immunosuppression or transplant. Non-invasive, quantitative MRI can characterise liver tissue to aid in the diagnosis of liver disorders. Using quantitative MRI in the management of AIH patients could be an invaluable asset within the standard care pathway to ensure more appropriate and accurate dosing of steroids is used in AIH patients, thus preventing over/under treating.

NCT ID: NCT03979027 Completed - Healthy Clinical Trials

Acute Effects of Breakfast Compared With No Breakfast on Cognitive Function and Subjective State in 11-13 Year Old Children

Start date: January 4, 2011
Phase: N/A
Study type: Interventional

This study is a school-based, randomised, controlled, parallel groups trial to examine the acute effect of breakfast (ready-to-eat-cereal and milk) vs. no breakfast on cognitive function and subjective state in 11-13 year old adolescents. It was hypothesised that the consumption of breakfast will have a positive acute effect on cognitive performance and subjective state compared with breakfast omission in 11-13 year olds.

NCT ID: NCT03978546 Completed - Glaucoma Clinical Trials

Diagnostic Performance of Smart Supra Perimetry (The DPSSP Study)

DPSSP
Start date: June 11, 2019
Phase: N/A
Study type: Interventional

Early glaucomatous visual field changes can be missed with the routinely used Standard Automated Perimetry (SAP) and the 24-2 test pattern due to limited sampling of the central 10 degrees. While this shortcoming can be overcome with the addition of a 10-2 test, performing both tests places extra demand on the perimetric services (doubling test times) and patients. Smart Supra Perimetry (SSP) uses a new faster algorithm that can complete both 24-2 and 10-2 test patterns in a similar time frame to a single 24-2 SAP test. This comparative study aims to determine the sensitivity and specificity (i.e. diagnostic accuracy) of SSP in identifying early glaucomatous visual field loss. A sample of 100 patients with early/suspect glaucoma will undergo SAP 24-2 and 10-2 (SITA algorithm) using Humphrey visual field perimetry and SSP 24+10-2 using Henson 9000. Eyes will be categorised into 2 groups i.e., glaucoma and non-glaucoma, on the basis of structural changes to the disc as evaluated by the clinician. The sensitivity and specificity of the SAP and SSP tests will be established along with test duration. The size and location of defects established with both the SAP and SSP strategies will also be compared.

NCT ID: NCT03978520 Completed - Clinical trials for Systemic Lupus Erythematosus (SLE)

A Study to Investigate the Safety and Efficacy of Elsubrutinib and Upadacitinib Given Alone or in Combination in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)

SLEek
Start date: July 25, 2019
Phase: Phase 2
Study type: Interventional

The main objective of this study was to evaluate the safety and efficacy of elsubrutinib, upadacitinib (UPA), and ABBV-599 (elsubrutinib/upadacitinib) High Dose and Low Dose combinations vs placebo for the treatment of signs and symptoms of Systemic Lupus Erythematosus (SLE) in participants with moderately to severely active SLE and to define doses for further development.

NCT ID: NCT03977051 Completed - Clinical trials for Adherence, Medication

Exploring Immunosuppressant Medication Adherence in Kidney Transplant Patients

Start date: February 8, 2017
Phase:
Study type: Observational

To describe the beliefs, understanding and experience of immunosuppressant medication adherence in our current transplant patient population through a series of patient focus groups

NCT ID: NCT03975738 Completed - Clinical trials for Healthcare Providers

Map Healthcare Provision Outside the NHS

VOICE
Start date: September 7, 2020
Phase:
Study type: Observational

- To collect data to show which sites outside of the NHS are currently being signposted to patients by Healthcare Multidisciplinary Professionals - To collect data about these sites, from patients who have been referred or signposted to sites outside of the NHS from a Healthcare Multidisciplinary Professional - To develop a database of potential healthcare sites outside the NHS that could become involved in NIHR Healthcare

NCT ID: NCT03972332 Completed - Low Back Pain Clinical Trials

Pain Experience in Individuals With Chronic Low Back Pain

Start date: July 27, 2018
Phase:
Study type: Observational

Low back pain is a very common musculoskeletal condition that affects many people each year regardless of age, gender, and ethnicity. Most people get better however, some continue suffering from painful episodes despite treatment. Self-management strategies for the management of chronic low back pain are very important to patients as they help them develop skills to manage their pain more effectively. However, self-management strategies are not always effective as expected. It is possible that the brain has become very sensitive to signals coming from peripheral parts of the body (e.g. low back) affecting the ability of patients to self-manage their condition. The aim of this study is to establish whether central sensitisation (sensitivity of the brain to peripheral signals) predicts how effective self-management approaches will be. On three different occasions, scheduled sessions will include a clinical assessment session and completion of a questionnaire booklet. The clinical assessment will measure three features of central sensitisation: 1) sensitivity to blunt pressure on the forearm, 2) changes in pain, felt during repeated light pricking of the forearm skin, and 3) reduction in pain that accompanies inflation of a blood pressure cuff on the opposite arm. Participant involvement at each session is expected to last for 70 minutes. Individuals over 18, diagnosed with chronic low back pain and enlisted to follow a pain management program are eligible to participate. The clinical assessments, questionnaire completion and subsequent statistical analysis are expected to be completed within 18 months of study commencement. Based on our findings, future research may use similar clinical assessment to identify people who might be helped to self-manage by using treatment that reduces central sensitisation.

NCT ID: NCT03971422 Completed - Clinical trials for Generalized Myasthenia Gravis

A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Start date: June 3, 2019
Phase: Phase 3
Study type: Interventional

The purpose of the MycarinGstudy is to demonstrate the clinical efficacy and to assess safety and tolerability of rozanolixizumab in patients with generalized myasthenia gravis (MG).