Rituximab in Interstitial Pneumonitis

Sponsor
Human Adams
Study ID
NCT02251964
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Lung Diseases, Interstitial
  • Pneumonitis, Interstitial

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
May 2018
Primary completion
Oct 31, 2017
Completion
Feb 28, 2018

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: rituximab
    single arm study with Zr-89-rituximab immuno PET/CT

Primary Outcome Measure

Pulmonary function (VC, DLCO) [ Time Frame: 6 - 12 months ]

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