Rituximab Therapy in Patients With Treatment Refractory Hypersenstivity Pneumonitis

Conditions

• Hypersenstivity Pneumonitis
• ILD

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Rituximab (Mabthera) — DRUG
  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.

Study Details

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).

Key Dates

Start date

Jun 1, 2023

Status verified

Jun 2025

Primary completion

Jan 31, 2025

Completion

Jan 31, 2025

Study Design

Enrollment

30 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Rituximab in treatment refractory Hypersenstivity pneumonitis
  Patients diagnosed with chronic Hypersensitivity Pneumonitis who have not responded to standard treatment including antigen avoidance and immunosuppressive therapy.

Primary Outcome Measure

Change in FVC (% of the predicted value) in chronic hypersensitivity pneumonitis patients 6 months after initiation of Rituximab therapy. [ Time Frame: From enrollment to the end of treatment and follow up of the clinical and functional status 18 months ]