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