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Necrobiosis lipoidica is a rare, chronic skin condition predominantly associated with diabetes mellitus (known as necrobiosis lipoidica diabeticorum or NLD). [1] It can also occur in individuals with rheumatoid arthritis or without any underlying conditions ( idiopathic ). [ 2 ]
The monotherapy trials were identically designed, 16-week, randomized, multicenter, double-blind, placebo-controlled, parallel group, phase 3 trials. [11] Trial-AD-3 with concomitant background therapy was a 24-week, multicenter, randomized, double-blind, active-comparator (dupilumab) and placebo-controlled, phase 3 trial. [ 11 ]
Designated an orphan drug in 2003 under United States law, clinical trials demonstrated romiplostim to be effective in treating chronic ITP, especially in relapsed post-splenectomy patients. [ 32 ] [ 33 ] Romiplostim was approved by the United States Food and Drug Administration (FDA) for long-term treatment of adult chronic ITP on August 22, 2008.
Thrombotic thrombocytopenic purpura (TTP) is a blood disorder that results in blood clots forming in small blood vessels throughout the body. [2] This results in a low platelet count, low red blood cells due to their breakdown, and often kidney, heart, and brain dysfunction. [1]
Necrobiosis is the physiological death of a cell, and can be caused by conditions such as basophilia, erythema, or a tumor. It is identified both with [ 1 ] and without necrosis . Necrobiotic disorders are characterized by presence of necrobiotic granuloma on histopathology.
Clinical trials may test an unknown procedure or may continue for years, and there is justifiable concern about enrolling participants and exposing them to an unproven treatment without ongoing oversight of the preliminary results. The DMC is a group (typically 3 to 7 members) who are independent of the entity conducting the trial.
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Organizations, both commercial and non-commercial, which are notable for their involvement in clinical trials. This involvement can be in sponsoring, conducting, managing, designing, organizing, or in any other way participating in topics related to the conduct of clinical trials.