NCT02251964

Rituximab in Interstitial Pneumonitis

Rituximab in Life Threatening Therapy Resistant Progressive Interstitial Pneumonitis

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Human Adams · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This project will address rare immune mediated inflammatory diseases (IMIDs) involving the lungs, i.e. interstitial pneumonitis (IP). The main objective of this study is to assess the effects of rituximab (RTX) as a rescue therapy for progressive IMID-IP patients. The primary study parameter is pulmonary function. The secondary objectives are to explore the application of imaging with radiolabeled RTX as early predictor for efficacy of RTX, to study the effects of RTX treatment on quality of life, and to further elucidate the pathophysiology of IMID-IP by analyzing biochemical markers.

Conditions

• Lung Diseases, Interstitial
• Pneumonitis, Interstitial

Interventions

Type	Name	Description
DRUG	Rituximab	2 times 1000mg dose at 14 days interval treatment
RADIATION	Zr-89-rituximab immuno PET/CT	Immuno labeled PET/CT of the lungs

Timeline

• Start date: 2014-09-01
• Primary completion: 2017-10-01
• Completion: 2018-02-01
• First posted: 2014-09-29
• Last updated: 2018-05-31

Locations

1 site across 1 country: Netherlands