This trial is evaluating whether Lenalidomide 10 mg will improve 4 primary outcomes, 1 secondary outcome, and 3 other outcomes in patients with Inflammation. Measurement will happen over the course of 18 months.
This trial requires 30 total participants across 2 different treatment groups
This trial involves 2 different treatments. Lenalidomide 10 Mg is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.
If inflammation could be completely eliminated, infection, [allergy](https://www.withpower.com/clinical-trials/allergy), and all the various disorders in the field of immunology, and others, which suffer from it, would suffer drastically. In addition, a cure would solve many health and social problems. Thus an effective inflammation cure is a strong imperative for many, though many others may not agree with the implication of the idea that “this is the ultimate goal of the health care system, an end to human suffering and inflammation”.
Inflammation is an important and frequently overlooked health concern. Most inflammation is chronic and associated with diseases, disorders and diseases of the heart, vascular, endocrine, muscular, immune, nervous, gastrointestinal, and respiratory systems.
Allergy and auto-immune disorders are commonly treated via the use of corticosteroids and medications such as antifungals, antibiotics, and other immunommodulators. Auto-immune disorders can be treated via immunosuppressant drugs such as azathioprine or cyclosporine.
Fever, low-grade malaise, weight loss and night sweats are symptoms of inflammation. Some signs of inflammation such as erythema are symptoms of an infection. \nThe main signs of an infection are the sudden onset of symptoms which may range from mild such as an increased temperature to severe and life-threatening such as pneumonia which is common in adults with diabetes. Fever is the most common presenting symptom of infections in persons with diabetes.\n\nSigns and symptoms of diabetes can be grouped into acute and chronic.\n\nDiabetic ketoacidosis is caused by insulin deficiency. It is usually caused by diabetes mellitus.
Inflammation can often be considered as the "symptom" of a more fundamental problem with the immune system, although genetic and hormonal changes are part of the pathogenesis of some kinds of inflammation. Some aspects of inflammation are related to immunity and inflammation can be modulated by immune manipulation, although the precise mechanisms by which this occurs is currently under investigation.
Chronic inflammation is common in America. Its prevalence changes little with ethnicity. It accounts for an estimated 2.2% of all visits and is responsible for 8% of most visits for conditions other than injury and is responsible for approximately 9% of all visits to primary care. The treatment options for chronic inflammatory disease (e.g., cholesterol, cardiovascular disease, nonalcoholic steatohepatitis, and type 2 diabetes) are relatively minor in primary care.
Recent findings demonstrates significantly higher improvements in QoL and BMD, and significantly greater overall improvements in the symptoms reported by the patients taking lenalidomide compared to the placebo patients. All patients' symptoms improved: osteoarthritis (69% vs. 9%, P<or =0.0001), malaise (53% vs. 6%, P<or =0.0001), and swelling (46% vs. 8%, P<or = 0.001).
As a treatment option for moderate-to-severe active myelodysplastic syndromes, lenalidomide 10 mg (one morning infusion) is just as effective as the lenalidomide/rifampin combination and has a more tolerable adverse-reaction profile.
Lenalidomide 10 mg was a beneficial and well-tolerated drug in more than 25% of our patients, although they were typically treated in combination with other drugs (including steroids, a PASTA strategy, and/or other cytoreductive agents). The combination of lenalidomide with corticosteroids appeared to confer additive activity and may be a viable regimen for refractory PRA.
These family data lend strong support to a major genetic contribution to inflammatory reactions, suggesting that genetic variants influencing inflammation may be located within the inflammatory cascade. Further studies that integrate disparate biological approaches such as cytokines, chemokines, and toll-like receptors may lead to the identification of critical genes and pathways underlying susceptibility to systemic inflammatory responses and their resolution.
Clinical trial research should take into account the possibility that inflammation is a useful concept that can help understand or diagnose disease. Clinical trials with inflammatory biomarkers should be made available to practicing clinicians for research purposes. The development of new biomarkers to guide patient therapy would benefit from a clearer understanding of the inflammatory markers used in clinical research. Moreover, clinical trial research on inflammation will help standardize therapies, treatments and trial outcomes that are tailored to the inflammatory profile (including genetic factors and biomarkers) of each patient.
While there have been multiple trials studying the efficacy of novel biologic medicines, the majority have come from small, non-consecutive series of patients. Additional studies with larger numbers of patients are needed to determine the effects of these treatments.