At a glance
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Rituximab Therapy in Patients With Treatment Refractory Hypersenstivity Pneumonitis
In Brief
A Phase 2 clinical trial evaluating Rituximab (Mabthera) for Hypersenstivity Pneumonitis and ILD. Completed, enrolled 30 participants across 1 site.
Detailed Summary
Hypersensitivity pneumonitis (HP) presents with a highly variable clinical course, and Traditional treatment involves systemic corticosteroids in conjunction with strict avoidance of the offending antigen. However, a subset of patients with progressive disease remains unresponsive to conventional therapies. The objective of this study is to evaluate the therapeutic potential of Rituximab in individuals with refractory hypersensitivity pneumonitis who did not respond to conventional immunosuppressive therapy and antigen avoidance. Assessing FVC at three intervals: six months prior to the initiation of Rituximab therapy (M-6), at the time of treatment initiation (M0), and six months afterward (M+6).
Study Details
Timeline
Interventions
In Chronic hypersensitivity pneumonitis patients with no improvement in lung function (deterioration in their FVC% predicted more than or equal 5%) after a minimum of 6 months treatment including antigen avoidance and immunosuppressive therapy. Rituximab will be administered by an intravenous infusion. * Two doses of Rituximab will be given, the first dose at day 0 and the second dose at day 15, 1 gram of Rituximab will be given in each dose. * Patients will be given acetaminophen and antihistamine before each infusion. * Rituximab will be diluted in an infusion bag of either 0.9% sodium chloride or 5% dextrose. * No other drugs will be mixed with it, and patients will be closely monitored for any infusion reactions.