Rituximab in Rheumatoid Arthritis Lung Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Eric Matteson
Study ID
NCT00578565
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 31, 2007
Status verified
Sep 2012
Primary completion
Jun 30, 2011
Completion
Jun 30, 2011

Study Design

Enrollment
10 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    open label, all subjects will receive rituximab

Primary Outcome Measure

Change in Diffusion Capacity for Carbon Monoxide (DLco) From Baseline to 48 Weeks [ Time Frame: baseline, 48 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Mayo ClinicRochesterMinnesota55905-

Find similar trials in Boston, MA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Brigham and Women's Hospital· Boston, MAMayo Clinic· Rochester, MN

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