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
Metroplex Clinical Research
Dallas, Texas 75231
1546
mi
from 02139
Dallas, TX
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
1017
mi
from 02139
Jacksonville, FL
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Borgess Research Institute
1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
737
mi
from 02139
Kalamazoo, MI
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Sentara Medical Group
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
467
mi
from 02139
Norfolk, VA
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Spartanburg Medical Research
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
776
mi
from 02139
Spartanburg, SC
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Center for Rheumatology
Albany, New York 12206
137
mi
from 02139
Albany, NY
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Aamr Research Clinic
Amarillo, Texas 79106
?
mi
from 02139
Amarillo, TX
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Amarillo Center for Clinical Research
Amarillo, Texas 79124
1716
mi
from 02139
Amarillo, TX
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Clinsite;Research Division of Integrated Health Associates
Ann Arbor, Michigan 48106
?
mi
from 02139
Ann Arbor, MI
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Pinnacle Research Group; Llc, Central
321 East 10th Street
Anniston, Alabama 36207
999
mi
from 02139
Anniston, AL
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The Arthritis Clinic of Northern Virginia, PA
Arlington, Virginia 22205
395
mi
from 02139
Arlington, VA
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Asheville Arthritis & Osteoporosis Center, PA
4 Vanderbilt Park Drive
Asheville, North Carolina 28803
772
mi
from 02139
Asheville, NC
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Atlanta Center for Clinical Research
Atlanta, Georgia 30342
927
mi
from 02139
Atlanta, GA
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University of Colorado Cancer Center
Aurora, Colorado 80045
1755
mi
from 02139
Aurora, CO
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Austin Rheumatology Research PA
Austin, Texas 78705
1691
mi
from 02139
Austin, TX
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Walter F. Chase
Austin, Texas 78705
1690
mi
from 02139
Austin, TX
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Arthritis & Rheumatism; Disease Specialities
21097 Northeast 27th Court
Aventura, Florida 33180
1243
mi
from 02139
Aventura, FL
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Johns Hopkins University; Department of Rheumatology
Baltimore, Maryland 21224
?
mi
from 02139
Baltimore, MD
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The Baton Rouge Clinic, AMC
Baton Rouge, Louisiana 70808
1381
mi
from 02139
Baton Rouge, LA
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Arthritis Associates
Belmont, North Carolina 28012
?
mi
from 02139
Belmont, NC
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Bend Memorial Clinic
Bend, Oregon 97701
2490
mi
from 02139
Bend, OR
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East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18015
248
mi
from 02139
Bethlehem, PA
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Rheumatology Associates, PC
Birmingham, Alabama 35205
1049
mi
from 02139
Birmingham, AL
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St. Alexius Medical Center; Arthritis Clinic
310 North 10th Street
Bismarck, North Dakota 58501
1482
mi
from 02139
Bismarck, ND
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'Intermountain Orthopaedics
Boise, Idaho 83702
2252
mi
from 02139
Boise, ID
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Arthritis & Osteoporosis Center
186 Joralemon Street
Brooklyn, New York 11201
188
mi
from 02139
Brooklyn, NY
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Organizacion Medica de Investigacion
725 Uruguay
Buenos Aires, C1015ABO
5378
mi
from 02139
Buenos Aires,
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Arthritis & Osteoporosis Center P.C.
Camden, Connecticut 06510
?
mi
from 02139
Camden, CT
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Physician's Clinic of Iowa, P.C.
Cedar Rapids, Iowa 52401
1051
mi
from 02139
Cedar Rapids, IA
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Low Country Research Center
Charleston, South Carolina 29406
814
mi
from 02139
Charleston, SC
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Metrolina Medical Research
1700 Abbey Place
Charlotte, North Carolina 28209
722
mi
from 02139
Charlotte, NC
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Carolina Bone and Joint
Charlotte, North Carolina 29425
819
mi
from 02139
Charlotte, NC
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Uni of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
845
mi
from 02139
Chicago, IL
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Deaconess Arthritis Center; Rheumatic Disease Study Group
Cincinnati, Ohio 45219
?
mi
from 02139
Cincinnati, OH
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University Hospitals at Case Medical Center
Cleveland, Ohio 44194
544
mi
from 02139
Cleveland, OH
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Coeur D'Alene Arthritis Clinic
Coeur D'Alene, Idaho 83814
2227
mi
from 02139
Coeur D'Alene, ID
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Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado 80920
1773
mi
from 02139
Colorado Springs, CO
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Csi Research, Inc.
Cumming, Georgia 30041
?
mi
from 02139
Cumming, GA
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Arthritis Care and Diagnostic Center
Dallas, Texas 75321
1546
mi
from 02139
Dallas, TX
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Arthritis Care and Research Centre
Dallas, Texas 75231
?
mi
from 02139
Dallas, TX
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Arthritis Centers of Texas
Dallas, Texas
1547
mi
from 02139
Dallas, TX
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Uni of Texas Southwestern Medical Center; Internal Medicine
Dallas, Texas 75390
?
mi
from 02139
Dallas, TX
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STAT Research, Inc.
Dayton, Ohio 45417
707
mi
from 02139
Dayton, OH
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Seacoast Arthritis and Osteoporosis Center
Dover, New Hampshire 03820
?
mi
from 02139
Dover, NH
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St Luke's Whiteside Research
Duluth, Minnesota 55805
?
mi
from 02139
Duluth, MN
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St. Mary'S Duluth Clinic Health System; Rheumatology Dept
Duluth, Minnesota 55805
?
mi
from 02139
Duluth, MN
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St. Paul Rheumatology, PA
Eagan, Minnesota 55121
1112
mi
from 02139
Eagan, MN
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Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky 42701
?
mi
from 02139
Elizabethtown, KY
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Arthritis Associates
Erie, Pennsylvania 16508
460
mi
from 02139
Erie, PA
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Rheumatology Associates of NW Pa
Erie, Pennsylvania 16508
?
mi
from 02139
Erie, PA
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Pro Research
Eugene, Oregon 97401
2576
mi
from 02139
Eugene, OR
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Evanston Northwestern Healthcare; Rheumatology
Evanston, Illinois 60201
?
mi
from 02139
Evanston, IL
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David S. Rosenberg, M.D
Florissant, Missouri 63031
1035
mi
from 02139
Florissant, MO
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Jackson Arthritis Clinic
4436 Mangum Drive
Flowood, Mississippi 39232
1248
mi
from 02139
Flowood, MS
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Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina 29644
799
mi
from 02139
Fountain Inn, SC
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Rheumatic Disease Center
Glendale, Wisconsin 53217
854
mi
from 02139
Glendale, WI
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Physician's East
Greenville, North Carolina 27834
574
mi
from 02139
Greenville, NC
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Mark Fisher Md, Facr, Llc
Haddon Heights, New Jersey 08035
?
mi
from 02139
Haddon Heights, NJ
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Unifour Medical Research Associates
Hickory Grove, South Carolina 28602
?
mi
from 02139
Hickory Grove, SC
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CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas 71913
1300
mi
from 02139
Hot Springs, AR
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
986
mi
from 02139
Huntsville, AL
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Iu Outpatient Clinical Research Facility
Indianapolis, Indiana 46202
?
mi
from 02139
Indianapolis, IN
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Diagnostic Rheumatology and Research PC
Indianapolis, Indiana 46227
802
mi
from 02139
Indianapolis, IN
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West Tennessee Research Institute
Jackson, Tennessee 38305
1056
mi
from 02139
Jackson, TN
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Rheumatology, P.C.; Medical Arts Building
Kalamazoo, Michigan 49009
?
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Kalamazoo, MI
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Uni of Kansas Medical Center
Kansas City, Kansas 66160
?
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Kansas City, KS
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Rheumatology Consultants Pllc
Knoxville, Tennessee 37909
820
mi
from 02139
Knoxville, TN
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Allergy & Rheumatology Centre
La Jolla, California 92037
?
mi
from 02139
La Jolla, CA
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Portland Rheumatology Clinic, Llc
Lake Oswego, Oregon 97035
2531
mi
from 02139
Lake Oswego, OR
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Fiechtner Research, Inc.
Lansing, Michigan 48910
684
mi
from 02139
Lansing, MI
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Rheumatolgy Consultants of Deleware
1532 Savannah Road
Lewes, Delaware 19958
327
mi
from 02139
Lewes, DE
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Bluegrass Comm Research, Inc.
470 Cooper Drive
Lexington, Kentucky 40515
767
mi
from 02139
Lexington, KY
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Little Rock Diagnostic Clinic
Little Rock, Arkansas 72205
1257
mi
from 02139
Little Rock, AR
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Private Practice
Long Beach, California 90808
?
mi
from 02139
Long Beach, CA
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Valerius Medical Group & Research Ctr of Greater Long Beach
10861 Cherry Street
Los Alamitos, California 90720
2587
mi
from 02139
Los Alamitos, CA
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Uni of Southern California School of Medicine
Los Angeles, California 90033
?
mi
from 02139
Los Angeles, CA
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Pacific Arthritis Care Center
Los Angeles, California 90045
2588
mi
from 02139
Los Angeles, CA
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Kentuckiana Center For Better Bone & Joint Healthx
Louisville, Kentucky 40202
?
mi
from 02139
Louisville, KY
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Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas 79424
1775
mi
from 02139
Lubbock, TX
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Marietta Rheumatology Associates
Marietta, Georgia 30060
931
mi
from 02139
Marietta, GA
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David Mandel Inc
Mayfield, Ohio 44143
?
mi
from 02139
Mayfield, OH
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The Arthritis Group, Pc
Memphis, Tennessee 38104
1131
mi
from 02139
Memphis, TN
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Ramesh Gupta
Memphis, Tennessee 38119
1132
mi
from 02139
Memphis, TN
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Idaho Arthritis Center
Meridian, Idaho
2261
mi
from 02139
Meridian, ID
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Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona 85202
2284
mi
from 02139
Mesa, AZ
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Arthrocare, Arthritis Care and Research, P.C.
Mesa, Arizona 85208
?
mi
from 02139
Mesa, AZ
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Southwest Rheumatology, PA
Mesquite, Texas 75150
1537
mi
from 02139
Mesquite, TX
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Paramount Medical Research
Middleburg Heights, Ohio 44130
555
mi
from 02139
Middleburg Heights, OH
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Park Nicollet Inst. ; Rtrc
Minneapolis, Minnesota 55416
?
mi
from 02139
Minneapolis, MN
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Quad City Rheumatology, Sc
Moline, Illinois 61265
?
mi
from 02139
Moline, IL
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Illinois Bone & Joint Inst.
Morton Grove, Illinois 60053
?
mi
from 02139
Morton Grove, IL
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Medical Specialists Clinical Research Center
Munster, Indiana 46321
?
mi
from 02139
Munster, IN
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Nashua Rheumatology - Foundation Medical Partners
Nashua, New Hampshire 03060
33
mi
from 02139
Nashua, NH
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Javed Rheumatology Associates
Newark, Delaware 19713
304
mi
from 02139
Newark, DE
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Medical Uni of South Carolina
171 Ashley Avenue
North Charleston, South Carolina 29425
819
mi
from 02139
North Charleston, SC
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Health Research of Oklahoma
Oklahoma City, Oklahoma 73103
1489
mi
from 02139
Oklahoma City, OK
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Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
1489
mi
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Oklahoma City, OK
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Southern Tier Arthritis and Rheumatism
Olean, New York 14760
375
mi
from 02139
Olean, NY
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Westroads Medical Group
Omaha, Nebraska 68114
1282
mi
from 02139
Omaha, NE
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Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
3111 Gundersen Drive
Onalaska, Wisconsin 54605
1015
mi
from 02139
Onalaska, WI
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Arthritis Center Palm Harbor
32615 US Highway 19 North
Palm Harbor, Florida 34684
1183
mi
from 02139
Palm Harbor, FL
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