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Rituximab in Interstitial Pneumonitis

NCT02251964 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-05-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Amsterdam UMC, location VUmc

    collaborator OTHER

  • Human Adams

    lead OTHER

Principal Investigators

  • J C Grutters, MD, PhD · St. Antonius Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2017-10-31
Completion
2018-02-28

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02251964 on ClinicalTrials.gov