A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Don't Have a Response to Anti-TNF-α Therapy (SCRIPT)



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:May 15, 2007
End Date:May 18, 2018

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A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy

This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in
patients with active rheumatoid arthritis who have an inadequate response to at least one
anti-TNF-alpha therapy. Patients will be randomized to receive placebo, 200mg of intravenous
ocrelizumab, or 500mg of i.v. ocrelizumab on days 1 and 15. A repeat course of i.v. treatment
will be administered at weeks 24 and 26. All patients will receive stable doses of either
concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive
additional DMARDs. The anticipated time on study treatment is 1-2 years. Target sample size
is 1000.


Inclusion Criteria:

- Adult patients, ≥ 18 years of age

- Rheumatoid arthritis for ≥ 3 months

- Inadequate response to previous or current treatment with at least one anti-TNF-alpha
agent

- Receiving either leflunomide or methotrexate for ≥ 12 weeks, with a stable dose for
the last 4 weeks

Exclusion Criteria:

- Rheumatic autoimmune disease or inflammatory joint disease, other than RA

- Any surgical procedure in past 12 weeks,or planned within 48 weeks of baseline
We found this trial at
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Sugar Land, Texas 77479
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4085 University Blvd S # 1
Jacksonville, Florida 32216
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1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
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6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
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485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
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Albany, New York 12206
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Amarillo, Texas 79106
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321 East 10th Street
Anniston, Alabama 36207
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4 Vanderbilt Park Drive
Asheville, North Carolina 28803
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Atlanta, Georgia 30342
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Aurora, Colorado 80045
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Austin, Texas 78705
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21097 Northeast 27th Court
Aventura, Florida 33180
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Baton Rouge, Louisiana 70808
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Belmont, North Carolina 28012
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Bend, Oregon 97701
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Bethlehem, Pennsylvania 18015
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Birmingham, Alabama 35205
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310 North 10th Street
Bismarck, North Dakota 58501
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Boise, Idaho 83702
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186 Joralemon Street
Brooklyn, New York 11201
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725 Uruguay
Buenos Aires, C1015ABO
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Camden, Connecticut 06510
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Cedar Rapids, Iowa 52401
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Charleston, South Carolina 29406
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1700 Abbey Place
Charlotte, North Carolina 28209
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Charlotte, North Carolina 29425
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5801 South Ellis Avenue
Chicago, Illinois 60637
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Coeur D'Alene, Idaho 83814
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Cumming, Georgia 30041
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Eagan, Minnesota 55121
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Elizabethtown, Kentucky 42701
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Erie, Pennsylvania 16508
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Eugene, Oregon 97401
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Florissant, Missouri 63031
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4436 Mangum Drive
Flowood, Mississippi 39232
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Fountain Inn, South Carolina 29644
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Glendale, Wisconsin 53217
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Greenville, North Carolina 27834
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La Jolla, California 92037
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Lansing, Michigan 48910
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470 Cooper Drive
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Los Alamitos, California 90720
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Mayfield, Ohio 44143
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Memphis, Tennessee 38119
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North Charleston, South Carolina 29425
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Onalaska, Wisconsin 54605
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