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
'Intermountain Orthopaedics
Boise, Idaho 83702
1716
mi
from 43215
Boise, ID
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
673
mi
from 43215
Jacksonville, FL
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Borgess Research Institute
1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
208
mi
from 43215
Kalamazoo, MI
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Sentara Medical Group
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
427
mi
from 43215
Norfolk, VA
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Spartanburg Medical Research
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
349
mi
from 43215
Spartanburg, SC
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Center for Rheumatology
Albany, New York 12206
514
mi
from 43215
Albany, NY
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Aamr Research Clinic
Amarillo, Texas 79106
?
mi
from 43215
Amarillo, TX
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Amarillo Center for Clinical Research
Amarillo, Texas 79124
1078
mi
from 43215
Amarillo, TX
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Clinsite;Research Division of Integrated Health Associates
Ann Arbor, Michigan 48106
?
mi
from 43215
Ann Arbor, MI
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Pinnacle Research Group; Llc, Central
321 East 10th Street
Anniston, Alabama 36207
462
mi
from 43215
Anniston, AL
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The Arthritis Clinic of Northern Virginia, PA
Arlington, Virginia 22205
324
mi
from 43215
Arlington, VA
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Asheville Arthritis & Osteoporosis Center, PA
4 Vanderbilt Park Drive
Asheville, North Carolina 28803
305
mi
from 43215
Asheville, NC
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Atlanta Center for Clinical Research
Atlanta, Georgia 30342
427
mi
from 43215
Atlanta, GA
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University of Colorado Cancer Center
Aurora, Colorado 80045
1154
mi
from 43215
Aurora, CO
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Austin Rheumatology Research PA
Austin, Texas 78705
1065
mi
from 43215
Austin, TX
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Walter F. Chase
Austin, Texas 78705
1064
mi
from 43215
Austin, TX
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Arthritis & Rheumatism; Disease Specialities
21097 Northeast 27th Court
Aventura, Florida 33180
981
mi
from 43215
Aventura, FL
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Johns Hopkins University; Department of Rheumatology
Baltimore, Maryland 21224
?
mi
from 43215
Baltimore, MD
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The Baton Rouge Clinic, AMC
Baton Rouge, Louisiana 70808
802
mi
from 43215
Baton Rouge, LA
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Arthritis Associates
Belmont, North Carolina 28012
?
mi
from 43215
Belmont, NC
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Bend Memorial Clinic
Bend, Oregon 97701
1966
mi
from 43215
Bend, OR
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East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18015
407
mi
from 43215
Bethlehem, PA
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Rheumatology Associates, PC
Birmingham, Alabama 35205
493
mi
from 43215
Birmingham, AL
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St. Alexius Medical Center; Arthritis Clinic
310 North 10th Street
Bismarck, North Dakota 58501
1005
mi
from 43215
Bismarck, ND
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Arthritis & Osteoporosis Center
186 Joralemon Street
Brooklyn, New York 11201
478
mi
from 43215
Brooklyn, NY
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Organizacion Medica de Investigacion
725 Uruguay
Buenos Aires, C1015ABO
5385
mi
from 43215
Buenos Aires,
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Arthritis & Osteoporosis Center P.C.
Camden, Connecticut 06510
?
mi
from 43215
Camden, CT
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Physician's Clinic of Iowa, P.C.
Cedar Rapids, Iowa 52401
471
mi
from 43215
Cedar Rapids, IA
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Low Country Research Center
Charleston, South Carolina 29406
514
mi
from 43215
Charleston, SC
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Metrolina Medical Research
1700 Abbey Place
Charlotte, North Carolina 28209
352
mi
from 43215
Charlotte, NC
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Carolina Bone and Joint
Charlotte, North Carolina 29425
524
mi
from 43215
Charlotte, NC
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Uni of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
270
mi
from 43215
Chicago, IL
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Deaconess Arthritis Center; Rheumatic Disease Study Group
Cincinnati, Ohio 45219
?
mi
from 43215
Cincinnati, OH
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University Hospitals at Case Medical Center
Cleveland, Ohio 44194
138
mi
from 43215
Cleveland, OH
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Coeur D'Alene Arthritis Clinic
Coeur D'Alene, Idaho 83814
1748
mi
from 43215
Coeur D'Alene, ID
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Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado 80920
1163
mi
from 43215
Colorado Springs, CO
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Csi Research, Inc.
Cumming, Georgia 30041
?
mi
from 43215
Cumming, GA
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Arthritis Care and Diagnostic Center
Dallas, Texas 75321
911
mi
from 43215
Dallas, TX
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Arthritis Care and Research Centre
Dallas, Texas 75231
?
mi
from 43215
Dallas, TX
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Metroplex Clinical Research
Dallas, Texas 75231
911
mi
from 43215
Dallas, TX
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Arthritis Centers of Texas
Dallas, Texas
911
mi
from 43215
Dallas, TX
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Uni of Texas Southwestern Medical Center; Internal Medicine
Dallas, Texas 75390
?
mi
from 43215
Dallas, TX
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STAT Research, Inc.
Dayton, Ohio 45417
66
mi
from 43215
Dayton, OH
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Seacoast Arthritis and Osteoporosis Center
Dover, New Hampshire 03820
?
mi
from 43215
Dover, NH
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St Luke's Whiteside Research
Duluth, Minnesota 55805
?
mi
from 43215
Duluth, MN
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St. Mary'S Duluth Clinic Health System; Rheumatology Dept
Duluth, Minnesota 55805
?
mi
from 43215
Duluth, MN
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St. Paul Rheumatology, PA
Eagan, Minnesota 55121
616
mi
from 43215
Eagan, MN
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Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky 42701
?
mi
from 43215
Elizabethtown, KY
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Arthritis Associates
Erie, Pennsylvania 16508
211
mi
from 43215
Erie, PA
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Rheumatology Associates of NW Pa
Erie, Pennsylvania 16508
?
mi
from 43215
Erie, PA
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Pro Research
Eugene, Oregon 97401
2055
mi
from 43215
Eugene, OR
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Evanston Northwestern Healthcare; Rheumatology
Evanston, Illinois 60201
?
mi
from 43215
Evanston, IL
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David S. Rosenberg, M.D
Florissant, Missouri 63031
398
mi
from 43215
Florissant, MO
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Jackson Arthritis Clinic
4436 Mangum Drive
Flowood, Mississippi 39232
659
mi
from 43215
Flowood, MS
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Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina 29644
367
mi
from 43215
Fountain Inn, SC
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Rheumatic Disease Center
Glendale, Wisconsin 53217
335
mi
from 43215
Glendale, WI
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Physician's East
Greenville, North Carolina 27834
429
mi
from 43215
Greenville, NC
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Mark Fisher Md, Facr, Llc
Haddon Heights, New Jersey 08035
?
mi
from 43215
Haddon Heights, NJ
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Unifour Medical Research Associates
Hickory Grove, South Carolina 28602
?
mi
from 43215
Hickory Grove, SC
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CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas 71913
667
mi
from 43215
Hot Springs, AR
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
411
mi
from 43215
Huntsville, AL
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Iu Outpatient Clinical Research Facility
Indianapolis, Indiana 46202
?
mi
from 43215
Indianapolis, IN
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Diagnostic Rheumatology and Research PC
Indianapolis, Indiana 46227
166
mi
from 43215
Indianapolis, IN
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West Tennessee Research Institute
Jackson, Tennessee 38305
436
mi
from 43215
Jackson, TN
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Rheumatology, P.C.; Medical Arts Building
Kalamazoo, Michigan 49009
?
mi
from 43215
Kalamazoo, MI
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Uni of Kansas Medical Center
Kansas City, Kansas 66160
?
mi
from 43215
Kansas City, KS
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Rheumatology Consultants Pllc
Knoxville, Tennessee 37909
282
mi
from 43215
Knoxville, TN
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Allergy & Rheumatology Centre
La Jolla, California 92037
?
mi
from 43215
La Jolla, CA
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Portland Rheumatology Clinic, Llc
Lake Oswego, Oregon 97035
2027
mi
from 43215
Lake Oswego, OR
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Fiechtner Research, Inc.
Lansing, Michigan 48910
206
mi
from 43215
Lansing, MI
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Rheumatolgy Consultants of Deleware
1532 Savannah Road
Lewes, Delaware 19958
428
mi
from 43215
Lewes, DE
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Bluegrass Comm Research, Inc.
470 Cooper Drive
Lexington, Kentucky 40515
155
mi
from 43215
Lexington, KY
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Little Rock Diagnostic Clinic
Little Rock, Arkansas 72205
624
mi
from 43215
Little Rock, AR
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Private Practice
Long Beach, California 90808
?
mi
from 43215
Long Beach, CA
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Valerius Medical Group & Research Ctr of Greater Long Beach
10861 Cherry Street
Los Alamitos, California 90720
1969
mi
from 43215
Los Alamitos, CA
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Uni of Southern California School of Medicine
Los Angeles, California 90033
?
mi
from 43215
Los Angeles, CA
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Pacific Arthritis Care Center
Los Angeles, California 90045
1972
mi
from 43215
Los Angeles, CA
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Kentuckiana Center For Better Bone & Joint Healthx
Louisville, Kentucky 40202
?
mi
from 43215
Louisville, KY
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Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas 79424
1134
mi
from 43215
Lubbock, TX
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Marietta Rheumatology Associates
Marietta, Georgia 30060
423
mi
from 43215
Marietta, GA
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David Mandel Inc
Mayfield, Ohio 44143
?
mi
from 43215
Mayfield, OH
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The Arthritis Group, Pc
Memphis, Tennessee 38104
507
mi
from 43215
Memphis, TN
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Ramesh Gupta
Memphis, Tennessee 38119
508
mi
from 43215
Memphis, TN
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Idaho Arthritis Center
Meridian, Idaho
1725
mi
from 43215
Meridian, ID
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Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona 85202
1654
mi
from 43215
Mesa, AZ
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Arthrocare, Arthritis Care and Research, P.C.
Mesa, Arizona 85208
?
mi
from 43215
Mesa, AZ
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Southwest Rheumatology, PA
Mesquite, Texas 75150
901
mi
from 43215
Mesquite, TX
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Paramount Medical Research
Middleburg Heights, Ohio 44130
115
mi
from 43215
Middleburg Heights, OH
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Park Nicollet Inst. ; Rtrc
Minneapolis, Minnesota 55416
?
mi
from 43215
Minneapolis, MN
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Quad City Rheumatology, Sc
Moline, Illinois 61265
?
mi
from 43215
Moline, IL
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Illinois Bone & Joint Inst.
Morton Grove, Illinois 60053
?
mi
from 43215
Morton Grove, IL
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Medical Specialists Clinical Research Center
Munster, Indiana 46321
?
mi
from 43215
Munster, IN
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Nashua Rheumatology - Foundation Medical Partners
Nashua, New Hampshire 03060
629
mi
from 43215
Nashua, NH
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Javed Rheumatology Associates
Newark, Delaware 19713
386
mi
from 43215
Newark, DE
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Medical Uni of South Carolina
171 Ashley Avenue
North Charleston, South Carolina 29425
524
mi
from 43215
North Charleston, SC
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Health Research of Oklahoma
Oklahoma City, Oklahoma 73103
849
mi
from 43215
Oklahoma City, OK
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Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
848
mi
from 43215
Oklahoma City, OK
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Southern Tier Arthritis and Rheumatism
Olean, New York 14760
280
mi
from 43215
Olean, NY
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Westroads Medical Group
Omaha, Nebraska 68114
688
mi
from 43215
Omaha, NE
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Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
3111 Gundersen Drive
Onalaska, Wisconsin 54605
498
mi
from 43215
Onalaska, WI
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Arthritis Center Palm Harbor
32615 US Highway 19 North
Palm Harbor, Florida 34684
822
mi
from 43215
Palm Harbor, FL
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