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Rituximab in Rheumatoid Arthritis Lung Disease

NCT00578565 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-10-01

Study results available
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Summary

This study will examine the course of patients with progressive rheumatoid arthritis associated interstitial lung disease (RA-ILD) treated with rituximab for safety and progression-free survival at 48 weeks. Safety of rituximab therapy in this disease will be assessed through patient history, physical exams and laboratory parameters.

* Twelve male/or female patient with RA-associated lung disease (6 of each nonspecific interstitial pneumonia (NSIP) and usual interstitial pneumonia (UIP) histological subtype) will be enrolled
* The study involves 12 visits over 48 weeks
* Rituximab will be administered intravenously at Day 1 and Day 15 with repeat dosing at six months.

Conditions

Interventions

DRUG

Rituximab

Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • National Center for Research Resources (NCRR)

    collaborator NIH

  • Eric Matteson

    lead OTHER

Principal Investigators

  • Eric L Matteson, M.D., M.P.H. · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00578565 on ClinicalTrials.gov