Study of Vimseltinib for Tenosynovial Giant Cell Tumor
Tenosynovial Giant Cell TumorPigmented Villonodular Synovitis5 moreThis is a multicenter Phase 3 clinical study, which aims to evaluate the effectiveness of an investigational drug called vimseltinib for the treatment of tenosynovial giant cell tumor (TGCT) in cases where surgical removal of the tumor is not an option. The study consists of two parts. In Part 1, eligible study participants will be assigned to receive either vimseltinib or matching placebo for 24 weeks. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. MRI scans will be used to evaluate the response of the tumors to the treatment. Participants assigned to placebo in Part 1 will have the option to receive vimseltinib for Part 2. Part 2 is a long-term treatment phase in which all participants receive open-label vimseltinib.
A Phase 2 Study of Intravenous AMB-05X in Tenosynovial Giant Cell Tumor Patients
Tenosynovial Giant Cell TumorPigmented Villonodular Synovitis2 moreThe purpose of this Phase 2, open-label, multiple-dose, dose-escalation study is to evaluate intravenous AMB-05X in the treatment of patients with TGCT.
An Open-Label Study of Intra-articular AMB-05X Injections in Subjects With Tenosynovial Giant Cell...
Tenosynovial Giant Cell TumorPigmented Villonodular SynovitisAMB-051-01 is a multicenter study with an adaptive design that will enroll approximately 12 subjects with TGCT of the knee for 12 weeks of multiple-dose, open-label treatment with AMB-05X.
Corticosteroid Therapy for Persistent Synovitis in Acute Septic Arthritis on Native Joint
ArthritisSepticAcute septic arthritis is a rare but life-threatening and functionally serious disease. The improvement or disappearance of pain and functional recovery are sometimes difficult to obtain, with in some cases the persistence of synovitis due to a prolonged local inflammatory response, despite early and effective treatment. The consequences are significant for patients with often significant chronic pain, repercussions on autonomy and/or profession. An unfavorable evolution with joint destruction and need for replacement by a prosthesis is not uncommon. Corticosteroid therapy is widely used in rheumatology in similar tables, for the purpose of drug synovectomy, with good results. The risk of infection remains the main contraindication to its use. There are very few studies on its use in septic arthritis, either fundamentally or in humans, for which there are no data in adults. However, these have shown results encouraging the investigators not to neglect this therapy.
Early Changes in Pain, Disease Activity, and Ultrasound Evidence of Inflammatory Synovitis in Patients...
Rheumatoid ArthritisThe purpose of this phase 4 pilot study is to assess 1-year recruitment, and 6-month retention rates for participants with rheumatoid arthritis (RA) recruited to this study. Secondarily, we aim to study the difference in multifaceted pain scoring and Musculoskeletal Ultrasound (MSK-US)-detected synovitis between those treated with Upadacitinib vs Adalimumab.
MRI Evaluation Assessing Synovitis to Address the Unmet Need for Reliable Endpoints in SLE
Systemic Lupus Erythematosus ArthritisThis is an exploratory evaluation of MRI as a reliable, sensitive, and accurate outcome measure for clinical trials in SLE arthritis. Forty patients with SLE and moderate to severe synovitis (minimum of 3 tender and 3 swollen joints in wrists and hands) will be randomized to new or increased methotrexate therapy plus a single injection of Depomedrol or a matched placebo at baseline. Methotrexate will be injected subcutaneously once per week at ascending doses. The study will evaluate a range of outcomes discernable by MRI at 3 months and 6 months after baseline. We will also compare MRI findings, clinical endpoints, and biomarker changes in patients that were treated with Depomedrol vs. matched placebo at baseline.
Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care...
Hip EffusionSeptic Arthritis2 moreThe purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).
A Study of PLX73086 in Advanced Solid Tumors and Locally Advanced or Refractory Tenosynovial Giant...
Solid TumorsTenosynovial Giant Cell Tumor2 moreThe purpose of this research study is to evaluate safety, pharmacokinetics and preliminary efficacy of the investigational drug PLX73086 in subjects with solid tumors including subjects with locally advanced or refractory tenosynovial giant cell tumor (TGCT).
Elbow Arthroscopy Data Analysis
Osteoarthritis Elbow LeftOsteoarthritis Elbow Right6 moreThe purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. Patients who were 13 years old or greater at the time of arthroscopic osteocapsular release were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.
Intra-articular Bevacizumab for Recurrent Hemarthroses at Target Joints With Chronic Hemophilic...
HemophiliaSynovitisPrimary Objective The efficacy of intra-articular bevacizumab injection for secondary prevention of recurrent hemarthroses for hemophilia patients who has had target joints with chronic synovitis. The safety profiles of intra-articular bevacizumab injection for hemophilia patients. Study Population Adult hemophilia patients who have had one or more target joints with chronic synovitis and recurrent hemarthroses. Investigational therapy: Intra-articular injection of Bevacizumab (20 or 40 mg/ 0.8 or 1.6 ml/ dose) every month (28 days) for up to 4 months, depending on the improvement of target joint bleeding. Study Design The estimated study period is between Jan 2014 and Dec 2015. Totally 10 joints will be enrolled for this pilot study. Before enrollment, the joint(s) will be evaluated for their severity both clinically (by 10-point Pain Score, range of motion for the target joint, and World Federation of Hemophilia Score) and by MRI (using the compatible MRI scales developed by International Prophylaxis Study Group [IPSG]). Intra-articular injection of bevacizumab will be administered, after prophylactic factor supplementation, every month for up to four injections. In the first four patients, 20mg of bevacizumab will be administered. If there are no Gr 3 or Gr4 dose-limiting toxicities, bevacizumab dose will be escalated to 40mg in the other 6 patients. Before every procedure, the plasma and the synovial fluid samples will be collected for VEGF quantification for the correlative biomarker study. After completing the protocol treatment, the efficacy parameters as well as the safety profiles will be evaluated.