Rituximab for the Treatment of Rheumatoid Arthritis-Associated Interstitial Pneumonia: A Pilot Study

Status: Completed
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: No
View:

⁃ Diagnosis of RA according to the revised 1987 American Rheumatism Association criteria

⁃ Absence of clinical features suggesting infection, neoplasm, sarcoidosis, interstitial lung disease other than UIP or NSIP, other collagen vascular disease, or exposure to known fibrogenic drugs or environmental factors

⁃ Diagnosis of progressive interstitial pneumonia of UIP or NSIP subtype, based on the following criteria

⁃ Clinical symptoms consistent with interstitial lung disease with onset between 3 months and 36 months prior to screening.

⁃ Worsening as demonstrated by any one of the following within the past year:

⁃ > 10% decrease in Forced Vital Capacity (FVC)

⁃ increasing infiltrates on chest X-ray or High Resolution Computed Tomography (HRCT), or worsening dyspnea at rest or on exertion

⁃ Diagnosis of UIP or NSIP by either of the following:

⁃ Open or video-assisted thoracic surgery (VATS) lung biopsy showing definite or probable UIP or NSIP

⁃ HRCT scan showing definite or probable UIP or NSIP AND abnormal pulmonary function tests (reduced FVC or decreased diffusing capacity of carbon monoxide (DLco) or impaired gas exchange at rest or with exercise) AND insidious onset of otherwise unexplained dyspnea or exertion and bibasilar, inspiratory crackles on auscultation

⁃ FVC > 50% of predicted value at Screening

⁃ DLco >30% of predicted value at Screening

• No change of disease-modifying anti-rheumatic drug (DMARD) treatment within the last 3 months

Locations
United States
Massachusetts
Brigham and Women's Hospital
Boston
Minnesota
Mayo Clinic
Rochester
Time Frame
Start Date: May 2007
Completion Date: June 2011
Participants
Target number of participants: 10
Treatments
Experimental: 1
open label, all subjects will receive rituximab
Sponsors
Collaborators: Genentech, Inc., National Center for Research Resources (NCRR)
Leads: Eric Matteson

This content was sourced from clinicaltrials.gov

Similar Clinical Trials