Ongoing Clinical Trials for Synovitis
Synovitis is a condition involving inflammation of the joint lining that can cause pain, swelling, and stiffness. Currently, there are 2 clinical trials actively recruiting patients to test new treatments for this condition. These studies are taking place across several European countries and are investigating different approaches to managing joint inflammation and its symptoms.
Clinical trial locations
- Denmark
- France
- Netherlands
- Poland
- Spain
Study of intra-articular liraglutide (4P004) for patients with knee synovitis and osteoarthritis
This trial is investigating a new treatment approach for patients experiencing knee inflammation and osteoarthritis. The study tests an experimental medication called 4P-004, which contains the active substance liraglutide. What makes this treatment unique is that it is delivered directly into the knee joint through an injection, rather than being taken as a pill or injected elsewhere in the body.
Who can participate:
The study is looking for adults between 40 and 80 years old who have been experiencing knee pain from osteoarthritis for at least six months. Participants must weigh more than 40 kilograms and have a body mass index between 18.5 and 35. An important requirement is that the knee inflammation must be confirmed through an MRI scan before joining the study. Participants should be able to walk either on their own or with the help of a cane. Both men and women can take part in this research.
Who cannot participate:
The study cannot accept people who have had previous knee surgery or joint replacement in the knee being studied. Other reasons for exclusion include having other types of arthritis besides osteoarthritis, recent steroid injections in the target knee within the past three months, active knee infections, or severe obesity with a BMI greater than 40. People with autoimmune disorders, uncontrolled diabetes, severe heart, liver, or kidney disease, or active cancer within the past five years also cannot participate. The study is not open to pregnant or breastfeeding women, or those taking blood-thinning medications.
What the trial involves:
The main goal of this research is to determine how well 4P-004 works in reducing knee pain and whether it is safe to use. The treatment period lasts 12 weeks, during which participants will receive either the experimental medication or a placebo through injection. Neither participants nor their doctors will know which treatment is being given. Throughout the study, participants will attend follow-up visits at weeks 2, 4, 6, 8, 10, and 12. During these visits, doctors will evaluate knee pain using standardized assessment tools, conduct physical examinations, and collect blood and urine samples to monitor health. Participants will also need to track their daily knee pain levels and rate their pain during specific activities.
Investigational drug:
4P-004 is an experimental medication administered directly into the knee joint. It is being studied for its potential to reduce pain in patients with knee inflammation and osteoarthritis, with the main effectiveness assessment occurring at four weeks after treatment.
Study on the Safety and Effects of AMB-05X Injections for Patients with Tenosynovial Giant Cell Tumor
This clinical trial focuses on a specific condition called Tenosynovial Giant Cell Tumor, which affects the joints and causes inflammation of the joint lining. The study is testing a treatment called AMB-05X, which is given as an injection directly into the affected joint.
Who can participate:
This study is looking for adults aged 18 years or older who have been diagnosed with Tenosynovial Giant Cell Tumor affecting only one joint. The diagnosis must be confirmed by a pathologist, and if not previously confirmed, a biopsy will be needed before joining the study. Participants must have symptoms such as pain or stiffness, with a pain or stiffness score of at least 4 on standardized scales. The tumor must be measurable and at least 1 centimeter in size as shown on MRI scans. Participants must have never received AMB-05X in another study before. Their blood, liver, and kidney functions must be at acceptable levels. If participants are using prescription pain medication, they must have been on a stable regimen for at least two weeks before starting the study. Participants must be able to understand the study requirements and sign an informed consent form.
Who cannot participate:
People with conditions other than Tenosynovial Giant Cell Tumor cannot participate. Those who fall outside the specified age range or belong to vulnerable populations may not be eligible. Individuals who do not meet other specific health criteria set by the study will also be excluded.
What the trial involves:
The study is divided into two main parts. The first part is an initial treatment phase lasting 24 weeks, during which participants receive AMB-05X injections directly into the affected joint. The purpose of this phase is to evaluate the safety and effectiveness of the treatment. Throughout this period, researchers monitor how well the treatment works through regular assessments, including imaging tests to measure tumor size. At the end of the 24 weeks, doctors evaluate whether there has been a complete or partial reduction in tumor size and record any side effects experienced. Following the initial phase, participants may enter a long-term extension phase that allows for continued treatment or observation based on individual response. During the extension phase, additional doses of AMB-05X may be given if necessary. Throughout the entire study, participants undergo regular monitoring including measurements of joint function, pain levels, and overall quality of life, as well as blood tests to check medication levels and potential immune responses.
Investigational drug:
AMB-05X is an experimental medication administered through injections directly into the joint. It is being studied for its potential to treat Tenosynovial Giant Cell Tumor by targeting specific pathways involved in tumor growth, potentially reducing tumor size and impact. The study aims to assess its safety, tolerability, and effectiveness over a 24-week initial period and during a longer-term extension phase.
Summary
Currently, two clinical trials are actively recruiting patients with joint inflammation conditions. The first trial, available in Spain, Denmark, France, and Poland, focuses specifically on knee inflammation associated with osteoarthritis and is testing a medication called 4P-004 delivered directly into the knee joint. The second trial, taking place in the Netherlands, targets a specific type of tumor affecting joints and is testing AMB-05X. Both studies use intra-articular injections, meaning the medications are delivered directly into the affected joint rather than through traditional oral or systemic routes. These trials represent different approaches to managing joint inflammation, with one focusing on pain reduction in osteoarthritis and the other on tumor management. Patients interested in participating should carefully review the eligibility criteria and discuss with their healthcare providers whether these trials might be appropriate for their specific condition.
