Mastocytosis Clinical Trial
Official title:
The Effect of Xolair ® (Omalizumab) in Mastocytosis Patients Prospective Double-blind, Placebo-controlled, Multicentre Study, XOLMA-Study
Patients with mastocytosis often suffer from associated symptoms such as nausea, vertigo,
fatigue, urticaria, abdominal cramps, diarrhea or hypotension due to release of mediators by
mast cells. These patients have also an increased frequency of anaphylactic/anaphylactoid
reactions due to allergens such as hymenoptera or nonspecific stimuli such as contrast
media, local anesthetics or analgesics. In addition, there is increased osteoporosis in
mastocytosis patients due to the activity of mast cell mediators on osteoblasts and
osteoclasts. Symptoms of mastocytosis respond poorly to treatment with antihistamines or
other antiallergic drugs. There is currently no specific treatment for this disease with the
exception of rare cases. There are, however, some case reports suggesting that omalizumab
might decrease symptoms including hypotensive events.
The aim of the study is to investigate whether patients suffering from mastocytosis benefit
from a 6 month course of omalizumab with regard to symptoms and quality of life and whether
the applied in vitro and in vivo monitoring tools represent useful surrogate markers for the
efficacy of omalizumab in patients with mastocytosis.
- Trial with medicinal product
The study will take place as double-blind placebo controlled study. After a first a
run-period of 2 months for all participants randomization (1:1) in two group will take
place:
Group A: With omalizumab treatment for 6 months; dosage and administration schedule
according to body weight and total IgE level (1/2 of the patients). Group B: Placebo (1/2 of
the patients). After 4 months of treatment in both groups patients are encouraged to stop
all drugs given to reduce mast cell related effects, mainly antihistaminics . In case that
disturbing symptoms are reoccurring patients are allowed to restart these drugs. The
evaluation will take place after 5 months of treatment.
Finally, a follow up visit 1 and 4 months after the study will take place.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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