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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Trial Summary
Trial Overview
Inclusion Criteria

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
145
sites
Arthritis Northwest, Spokane
105 West 8th Avenue
Spokane, Washington 99204
1201
mi
from
Spokane, WA
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
1060
mi
from
Jacksonville, FL
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Borgess Research Institute
1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
720
mi
from
Kalamazoo, MI
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Sentara Medical Group
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
1187
mi
from
Norfolk, VA
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Spartanburg Medical Research
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
900
mi
from
Spartanburg, SC
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Center for Rheumatology
Albany, New York 12206
1308
mi
from
Albany, NY
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Aamr Research Clinic
Amarillo, Texas 79106
?
mi
from
Amarillo, TX
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Amarillo Center for Clinical Research
Amarillo, Texas 79124
283
mi
from
Amarillo, TX
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Clinsite;Research Division of Integrated Health Associates
Ann Arbor, Michigan 48106
?
mi
from
Ann Arbor, MI
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Pinnacle Research Group; Llc, Central
321 East 10th Street
Anniston, Alabama 36207
729
mi
from
Anniston, AL
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The Arthritis Clinic of Northern Virginia, PA
Arlington, Virginia 22205
1123
mi
from
Arlington, VA
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Asheville Arthritis & Osteoporosis Center, PA
4 Vanderbilt Park Drive
Asheville, North Carolina 28803
859
mi
from
Asheville, NC
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Atlanta Center for Clinical Research
Atlanta, Georgia 30342
798
mi
from
Atlanta, GA
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University of Colorado Cancer Center
Aurora, Colorado 80045
402
mi
from
Aurora, CO
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Austin Rheumatology Research PA
Austin, Texas 78705
517
mi
from
Austin, TX
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Walter F. Chase
Austin, Texas 78705
517
mi
from
Austin, TX
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Arthritis & Rheumatism; Disease Specialities
21097 Northeast 27th Court
Aventura, Florida 33180
1314
mi
from
Aventura, FL
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Johns Hopkins University; Department of Rheumatology
Baltimore, Maryland 21224
?
mi
from
Baltimore, MD
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The Baton Rouge Clinic, AMC
Baton Rouge, Louisiana 70808
631
mi
from
Baton Rouge, LA
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Arthritis Associates
Belmont, North Carolina 28012
?
mi
from
Belmont, NC
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Bend Memorial Clinic
Bend, Oregon 97701
1296
mi
from
Bend, OR
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East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18015
1217
mi
from
Bethlehem, PA
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Rheumatology Associates, PC
Birmingham, Alabama 35205
684
mi
from
Birmingham, AL
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St. Alexius Medical Center; Arthritis Clinic
310 North 10th Street
Bismarck, North Dakota 58501
643
mi
from
Bismarck, ND
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'Intermountain Orthopaedics
Boise, Idaho 83702
1041
mi
from
Boise, ID
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Arthritis & Osteoporosis Center
186 Joralemon Street
Brooklyn, New York 11201
1287
mi
from
Brooklyn, NY
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Organizacion Medica de Investigacion
725 Uruguay
Buenos Aires, C1015ABO
5601
mi
from
Buenos Aires,
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Arthritis & Osteoporosis Center P.C.
Camden, Connecticut 06510
?
mi
from
Camden, CT
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Physician's Clinic of Iowa, P.C.
Cedar Rapids, Iowa 52401
437
mi
from
Cedar Rapids, IA
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Low Country Research Center
Charleston, South Carolina 29406
1054
mi
from
Charleston, SC
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Metrolina Medical Research
1700 Abbey Place
Charlotte, North Carolina 28209
958
mi
from
Charlotte, NC
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Carolina Bone and Joint
Charlotte, North Carolina 29425
1063
mi
from
Charlotte, NC
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Uni of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
609
mi
from
Chicago, IL
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Deaconess Arthritis Center; Rheumatic Disease Study Group
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
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University Hospitals at Case Medical Center
Cleveland, Ohio 44194
898
mi
from
Cleveland, OH
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Coeur D'Alene Arthritis Clinic
Coeur D'Alene, Idaho 83814
1176
mi
from
Coeur D'Alene, ID
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Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado 80920
386
mi
from
Colorado Springs, CO
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Csi Research, Inc.
Cumming, Georgia 30041
?
mi
from
Cumming, GA
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Arthritis Care and Diagnostic Center
Dallas, Texas 75321
348
mi
from
Dallas, TX
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Arthritis Care and Research Centre
Dallas, Texas 75231
?
mi
from
Dallas, TX
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Metroplex Clinical Research
Dallas, Texas 75231
348
mi
from
Dallas, TX
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Arthritis Centers of Texas
Dallas, Texas
348
mi
from
Dallas, TX
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Uni of Texas Southwestern Medical Center; Internal Medicine
Dallas, Texas 75390
?
mi
from
Dallas, TX
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STAT Research, Inc.
Dayton, Ohio 45417
743
mi
from
Dayton, OH
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Seacoast Arthritis and Osteoporosis Center
Dover, New Hampshire 03820
?
mi
from
Dover, NH
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St Luke's Whiteside Research
Duluth, Minnesota 55805
?
mi
from
Duluth, MN
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St. Mary'S Duluth Clinic Health System; Rheumatology Dept
Duluth, Minnesota 55805
?
mi
from
Duluth, MN
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St. Paul Rheumatology, PA
Eagan, Minnesota 55121
546
mi
from
Eagan, MN
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Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky 42701
?
mi
from
Elizabethtown, KY
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Arthritis Associates
Erie, Pennsylvania 16508
983
mi
from
Erie, PA
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Rheumatology Associates of NW Pa
Erie, Pennsylvania 16508
?
mi
from
Erie, PA
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Pro Research
Eugene, Oregon 97401
1382
mi
from
Eugene, OR
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Evanston Northwestern Healthcare; Rheumatology
Evanston, Illinois 60201
?
mi
from
Evanston, IL
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David S. Rosenberg, M.D
Florissant, Missouri 63031
412
mi
from
Florissant, MO
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Jackson Arthritis Clinic
4436 Mangum Drive
Flowood, Mississippi 39232
575
mi
from
Flowood, MS
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Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina 29644
895
mi
from
Fountain Inn, SC
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Rheumatic Disease Center
Glendale, Wisconsin 53217
638
mi
from
Glendale, WI
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Physician's East
Greenville, North Carolina 27834
1139
mi
from
Greenville, NC
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Mark Fisher Md, Facr, Llc
Haddon Heights, New Jersey 08035
?
mi
from
Haddon Heights, NJ
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Unifour Medical Research Associates
Hickory Grove, South Carolina 28602
?
mi
from
Hickory Grove, SC
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CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas 71913
349
mi
from
Hot Springs, AR
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
659
mi
from
Huntsville, AL
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Iu Outpatient Clinical Research Facility
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
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Diagnostic Rheumatology and Research PC
Indianapolis, Indiana 46227
643
mi
from
Indianapolis, IN
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West Tennessee Research Institute
Jackson, Tennessee 38305
520
mi
from
Jackson, TN
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Rheumatology, P.C.; Medical Arts Building
Kalamazoo, Michigan 49009
?
mi
from
Kalamazoo, MI
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Uni of Kansas Medical Center
Kansas City, Kansas 66160
?
mi
from
Kansas City, KS
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Rheumatology Consultants Pllc
Knoxville, Tennessee 37909
772
mi
from
Knoxville, TN
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Allergy & Rheumatology Centre
La Jolla, California 92037
?
mi
from
La Jolla, CA
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Portland Rheumatology Clinic, Llc
Lake Oswego, Oregon 97035
1382
mi
from
Lake Oswego, OR
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Fiechtner Research, Inc.
Lansing, Michigan 48910
778
mi
from
Lansing, MI
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Rheumatolgy Consultants of Deleware
1532 Savannah Road
Lewes, Delaware 19958
1228
mi
from
Lewes, DE
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Bluegrass Comm Research, Inc.
470 Cooper Drive
Lexington, Kentucky 40515
725
mi
from
Lexington, KY
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Little Rock Diagnostic Clinic
Little Rock, Arkansas 72205
369
mi
from
Little Rock, AR
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Private Practice
Long Beach, California 90808
?
mi
from
Long Beach, CA
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Valerius Medical Group & Research Ctr of Greater Long Beach
10861 Cherry Street
Los Alamitos, California 90720
1164
mi
from
Los Alamitos, CA
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Uni of Southern California School of Medicine
Los Angeles, California 90033
?
mi
from
Los Angeles, CA
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Pacific Arthritis Care Center
Los Angeles, California 90045
1168
mi
from
Los Angeles, CA
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Kentuckiana Center For Better Bone & Joint Healthx
Louisville, Kentucky 40202
?
mi
from
Louisville, KY
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Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas 79424
372
mi
from
Lubbock, TX
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Marietta Rheumatology Associates
Marietta, Georgia 30060
788
mi
from
Marietta, GA
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David Mandel Inc
Mayfield, Ohio 44143
?
mi
from
Mayfield, OH
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The Arthritis Group, Pc
Memphis, Tennessee 38104
470
mi
from
Memphis, TN
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Ramesh Gupta
Memphis, Tennessee 38119
467
mi
from
Memphis, TN
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Idaho Arthritis Center
Meridian, Idaho
1050
mi
from
Meridian, ID
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Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona 85202
844
mi
from
Mesa, AZ
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Arthrocare, Arthritis Care and Research, P.C.
Mesa, Arizona 85208
?
mi
from
Mesa, AZ
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Southwest Rheumatology, PA
Mesquite, Texas 75150
346
mi
from
Mesquite, TX
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Paramount Medical Research
Middleburg Heights, Ohio 44130
887
mi
from
Middleburg Heights, OH
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Park Nicollet Inst. ; Rtrc
Minneapolis, Minnesota 55416
?
mi
from
Minneapolis, MN
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Quad City Rheumatology, Sc
Moline, Illinois 61265
?
mi
from
Moline, IL
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Illinois Bone & Joint Inst.
Morton Grove, Illinois 60053
?
mi
from
Morton Grove, IL
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Medical Specialists Clinical Research Center
Munster, Indiana 46321
?
mi
from
Munster, IN
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Nashua Rheumatology - Foundation Medical Partners
Nashua, New Hampshire 03060
1425
mi
from
Nashua, NH
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Javed Rheumatology Associates
Newark, Delaware 19713
1194
mi
from
Newark, DE
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Medical Uni of South Carolina
171 Ashley Avenue
North Charleston, South Carolina 29425
1063
mi
from
North Charleston, SC
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Health Research of Oklahoma
Oklahoma City, Oklahoma 73103
157
mi
from
Oklahoma City, OK
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Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
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Southern Tier Arthritis and Rheumatism
Olean, New York 14760
1067
mi
from
Olean, NY
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Westroads Medical Group
Omaha, Nebraska 68114
260
mi
from
Omaha, NE
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Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
3111 Gundersen Drive
Onalaska, Wisconsin 54605
546
mi
from
Onalaska, WI
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