A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 80
Updated:4/21/2016
Start Date:June 2004
End Date:June 2013

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An Open Label Study of the Efficacy and Safety of Re-treatments With Rituximab (MabThera/Rituxan) in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-TNFa Therapies

This study will assess the long-term safety and efficacy of repeating treatment with
MabThera, in combination with methotrexate and steroids, in patients who were previously
randomized into MabThera study WA17042. The anticipated time on study treatment is until
Mabthera is available on the local market and the target sample size is 100-500 individuals.


Inclusion Criteria:

- adult patients 18-80 years of age with active RA;

- patients who participated in MabThera study WA17042, and completed to at least the
Week 24 visit;

- eligible for re-treatment, based on clinical symptoms;

- patients of reproductive potential must be using reliable contraceptive methods.

Exclusion Criteria:

- patients who participated in MabThera study WA17042 but withdrew into the safety
follow-up;

- current treatment with any other disease-modifying antirheumatic drug (apart from
methotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;

- development of any new contraindications to receiving MabThera;

- women who are pregnant or breast-feeding.
We found this trial at
52
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Shreverport, LA
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Albany, NY
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Amarillo, TX
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Baltimore, MD
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Boca Raton, FL
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Boise, ID
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Boston, MA
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Bruxelles,
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Burlington, VT
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Chapel Hill, NC
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Chicago, IL
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Cincinnati, OH
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Coeur D'Alene, ID
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Dallas, TX
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Danbury, CT
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Dayton, OH
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Delray Beach, FL
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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2315
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Fort Lauderdale, FL
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Fullerton, CA
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Greenville, North Carolina 27834
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Greenville, NC
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Houston, TX
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Indianapolis, IN
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Jupiter, FL
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Kalamazoo, MI
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Lansing, MI
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Little Rock, AR
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Los Angeles, CA
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Madison, WI
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Manhasset, NY
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Mayfield, OH
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Meridian, ID
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Mesa, AZ
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New York, NY
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Oklahoma City, OK
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Orlando, FL
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349
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Paradise Valley, AZ
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Pasadena, CA
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Philadelphia, PA
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Rancho Mirage, California 90070
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Rancho Mirage, CA
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Rochester, MN
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Rochester, NY
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Saint Louis, MO
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Salt Lake City, UT
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Santa Maria, CA
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Seattle, WA
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Smithtown, NY
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Spokane, WA
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St Louis, MO
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427
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Tucson, AZ
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1253
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Tulsa, OK
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Waco, TX
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