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
Oklahoma Center for Arthritis Therapy & Research, Inc.
Tulsa, Oklahoma 74104
1560
mi
from 98109
Tulsa, OK
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
2456
mi
from 98109
Jacksonville, FL
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Borgess Research Institute
1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
1817
mi
from 98109
Kalamazoo, MI
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Sentara Medical Group
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
2435
mi
from 98109
Norfolk, VA
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Spartanburg Medical Research
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
2238
mi
from 98109
Spartanburg, SC
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Center for Rheumatology
Albany, New York 12206
2351
mi
from 98109
Albany, NY
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Aamr Research Clinic
Amarillo, Texas 79106
?
mi
from 98109
Amarillo, TX
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Amarillo Center for Clinical Research
Amarillo, Texas 79124
1358
mi
from 98109
Amarillo, TX
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Clinsite;Research Division of Integrated Health Associates
Ann Arbor, Michigan 48106
?
mi
from 98109
Ann Arbor, MI
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Pinnacle Research Group; Llc, Central
321 East 10th Street
Anniston, Alabama 36207
2117
mi
from 98109
Anniston, AL
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The Arthritis Clinic of Northern Virginia, PA
Arlington, Virginia 22205
2319
mi
from 98109
Arlington, VA
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Asheville Arthritis & Osteoporosis Center, PA
4 Vanderbilt Park Drive
Asheville, North Carolina 28803
2190
mi
from 98109
Asheville, NC
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Atlanta Center for Clinical Research
Atlanta, Georgia 30342
2174
mi
from 98109
Atlanta, GA
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University of Colorado Cancer Center
Aurora, Colorado 80045
1026
mi
from 98109
Aurora, CO
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Austin Rheumatology Research PA
Austin, Texas 78705
1770
mi
from 98109
Austin, TX
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Walter F. Chase
Austin, Texas 78705
1772
mi
from 98109
Austin, TX
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Arthritis & Rheumatism; Disease Specialities
21097 Northeast 27th Court
Aventura, Florida 33180
2724
mi
from 98109
Aventura, FL
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Johns Hopkins University; Department of Rheumatology
Baltimore, Maryland 21224
?
mi
from 98109
Baltimore, MD
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The Baton Rouge Clinic, AMC
Baton Rouge, Louisiana 70808
2028
mi
from 98109
Baton Rouge, LA
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Arthritis Associates
Belmont, North Carolina 28012
?
mi
from 98109
Belmont, NC
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Bend Memorial Clinic
Bend, Oregon 97701
249
mi
from 98109
Bend, OR
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East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18015
2342
mi
from 98109
Bethlehem, PA
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Rheumatology Associates, PC
Birmingham, Alabama 35205
2080
mi
from 98109
Birmingham, AL
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St. Alexius Medical Center; Arthritis Clinic
310 North 10th Street
Bismarck, North Dakota 58501
1010
mi
from 98109
Bismarck, ND
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'Intermountain Orthopaedics
Boise, Idaho 83702
406
mi
from 98109
Boise, ID
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Arthritis & Osteoporosis Center
186 Joralemon Street
Brooklyn, New York 11201
2403
mi
from 98109
Brooklyn, NY
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Organizacion Medica de Investigacion
725 Uruguay
Buenos Aires, C1015ABO
6918
mi
from 98109
Buenos Aires,
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Arthritis & Osteoporosis Center P.C.
Camden, Connecticut 06510
?
mi
from 98109
Camden, CT
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Physician's Clinic of Iowa, P.C.
Cedar Rapids, Iowa 52401
1542
mi
from 98109
Cedar Rapids, IA
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Low Country Research Center
Charleston, South Carolina 29406
2412
mi
from 98109
Charleston, SC
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Metrolina Medical Research
1700 Abbey Place
Charlotte, North Carolina 28209
2283
mi
from 98109
Charlotte, NC
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Carolina Bone and Joint
Charlotte, North Carolina 29425
2422
mi
from 98109
Charlotte, NC
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Uni of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
1737
mi
from 98109
Chicago, IL
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Deaconess Arthritis Center; Rheumatic Disease Study Group
Cincinnati, Ohio 45219
?
mi
from 98109
Cincinnati, OH
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University Hospitals at Case Medical Center
Cleveland, Ohio 44194
2016
mi
from 98109
Cleveland, OH
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Coeur D'Alene Arthritis Clinic
Coeur D'Alene, Idaho 83814
259
mi
from 98109
Coeur D'Alene, ID
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Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado 80920
1067
mi
from 98109
Colorado Springs, CO
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Csi Research, Inc.
Cumming, Georgia 30041
?
mi
from 98109
Cumming, GA
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Arthritis Care and Diagnostic Center
Dallas, Texas 75321
1681
mi
from 98109
Dallas, TX
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Arthritis Care and Research Centre
Dallas, Texas 75231
?
mi
from 98109
Dallas, TX
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Metroplex Clinical Research
Dallas, Texas 75231
1681
mi
from 98109
Dallas, TX
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Arthritis Centers of Texas
Dallas, Texas
1681
mi
from 98109
Dallas, TX
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Uni of Texas Southwestern Medical Center; Internal Medicine
Dallas, Texas 75390
?
mi
from 98109
Dallas, TX
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STAT Research, Inc.
Dayton, Ohio 45417
1957
mi
from 98109
Dayton, OH
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Seacoast Arthritis and Osteoporosis Center
Dover, New Hampshire 03820
?
mi
from 98109
Dover, NH
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St Luke's Whiteside Research
Duluth, Minnesota 55805
?
mi
from 98109
Duluth, MN
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St. Mary'S Duluth Clinic Health System; Rheumatology Dept
Duluth, Minnesota 55805
?
mi
from 98109
Duluth, MN
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St. Paul Rheumatology, PA
Eagan, Minnesota 55121
1399
mi
from 98109
Eagan, MN
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Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky 42701
?
mi
from 98109
Elizabethtown, KY
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Arthritis Associates
Erie, Pennsylvania 16508
2077
mi
from 98109
Erie, PA
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Rheumatology Associates of NW Pa
Erie, Pennsylvania 16508
?
mi
from 98109
Erie, PA
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Pro Research
Eugene, Oregon 97401
250
mi
from 98109
Eugene, OR
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Evanston Northwestern Healthcare; Rheumatology
Evanston, Illinois 60201
?
mi
from 98109
Evanston, IL
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David S. Rosenberg, M.D
Florissant, Missouri 63031
1709
mi
from 98109
Florissant, MO
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Jackson Arthritis Clinic
4436 Mangum Drive
Flowood, Mississippi 39232
1986
mi
from 98109
Flowood, MS
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Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina 29644
2240
mi
from 98109
Fountain Inn, SC
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Rheumatic Disease Center
Glendale, Wisconsin 53217
1683
mi
from 98109
Glendale, WI
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Physician's East
Greenville, North Carolina 27834
2426
mi
from 98109
Greenville, NC
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Mark Fisher Md, Facr, Llc
Haddon Heights, New Jersey 08035
?
mi
from 98109
Haddon Heights, NJ
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Unifour Medical Research Associates
Hickory Grove, South Carolina 28602
?
mi
from 98109
Hickory Grove, SC
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CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas 71913
1760
mi
from 98109
Hot Springs, AR
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
2038
mi
from 98109
Huntsville, AL
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Iu Outpatient Clinical Research Facility
Indianapolis, Indiana 46202
?
mi
from 98109
Indianapolis, IN
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Diagnostic Rheumatology and Research PC
Indianapolis, Indiana 46227
1868
mi
from 98109
Indianapolis, IN
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West Tennessee Research Institute
Jackson, Tennessee 38305
1900
mi
from 98109
Jackson, TN
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Rheumatology, P.C.; Medical Arts Building
Kalamazoo, Michigan 49009
?
mi
from 98109
Kalamazoo, MI
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Uni of Kansas Medical Center
Kansas City, Kansas 66160
?
mi
from 98109
Kansas City, KS
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Rheumatology Consultants Pllc
Knoxville, Tennessee 37909
2106
mi
from 98109
Knoxville, TN
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Allergy & Rheumatology Centre
La Jolla, California 92037
?
mi
from 98109
La Jolla, CA
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Portland Rheumatology Clinic, Llc
Lake Oswego, Oregon 97035
153
mi
from 98109
Lake Oswego, OR
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Fiechtner Research, Inc.
Lansing, Michigan 48910
1852
mi
from 98109
Lansing, MI
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Rheumatolgy Consultants of Deleware
1532 Savannah Road
Lewes, Delaware 19958
2414
mi
from 98109
Lewes, DE
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Bluegrass Comm Research, Inc.
470 Cooper Drive
Lexington, Kentucky 40515
2005
mi
from 98109
Lexington, KY
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Little Rock Diagnostic Clinic
Little Rock, Arkansas 72205
1779
mi
from 98109
Little Rock, AR
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Private Practice
Long Beach, California 90808
?
mi
from 98109
Long Beach, CA
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Valerius Medical Group & Research Ctr of Greater Long Beach
10861 Cherry Street
Los Alamitos, California 90720
980
mi
from 98109
Los Alamitos, CA
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Uni of Southern California School of Medicine
Los Angeles, California 90033
?
mi
from 98109
Los Angeles, CA
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Pacific Arthritis Care Center
Los Angeles, California 90045
962
mi
from 98109
Los Angeles, CA
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Kentuckiana Center For Better Bone & Joint Healthx
Louisville, Kentucky 40202
?
mi
from 98109
Louisville, KY
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Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas 79424
1440
mi
from 98109
Lubbock, TX
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Marietta Rheumatology Associates
Marietta, Georgia 30060
2163
mi
from 98109
Marietta, GA
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David Mandel Inc
Mayfield, Ohio 44143
?
mi
from 98109
Mayfield, OH
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The Arthritis Group, Pc
Memphis, Tennessee 38104
1867
mi
from 98109
Memphis, TN
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Ramesh Gupta
Memphis, Tennessee 38119
1864
mi
from 98109
Memphis, TN
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Idaho Arthritis Center
Meridian, Idaho
399
mi
from 98109
Meridian, ID
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Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona 85202
1125
mi
from 98109
Mesa, AZ
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Arthrocare, Arthritis Care and Research, P.C.
Mesa, Arizona 85208
?
mi
from 98109
Mesa, AZ
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Southwest Rheumatology, PA
Mesquite, Texas 75150
1685
mi
from 98109
Mesquite, TX
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Paramount Medical Research
Middleburg Heights, Ohio 44130
2019
mi
from 98109
Middleburg Heights, OH
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Park Nicollet Inst. ; Rtrc
Minneapolis, Minnesota 55416
?
mi
from 98109
Minneapolis, MN
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Quad City Rheumatology, Sc
Moline, Illinois 61265
?
mi
from 98109
Moline, IL
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Illinois Bone & Joint Inst.
Morton Grove, Illinois 60053
?
mi
from 98109
Morton Grove, IL
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Medical Specialists Clinical Research Center
Munster, Indiana 46321
?
mi
from 98109
Munster, IN
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Nashua Rheumatology - Foundation Medical Partners
Nashua, New Hampshire 03060
2454
mi
from 98109
Nashua, NH
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Javed Rheumatology Associates
Newark, Delaware 19713
2355
mi
from 98109
Newark, DE
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Medical Uni of South Carolina
171 Ashley Avenue
North Charleston, South Carolina 29425
2422
mi
from 98109
North Charleston, SC
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Health Research of Oklahoma
Oklahoma City, Oklahoma 73103
1522
mi
from 98109
Oklahoma City, OK
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Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
1523
mi
from 98109
Oklahoma City, OK
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Southern Tier Arthritis and Rheumatism
Olean, New York 14760
2154
mi
from 98109
Olean, NY
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Westroads Medical Group
Omaha, Nebraska 68114
1361
mi
from 98109
Omaha, NE
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Gundersen Clinic Ltd;Sec. Rheumatology/Dept. of Internal Med
3111 Gundersen Drive
Onalaska, Wisconsin 54605
1513
mi
from 98109
Onalaska, WI
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