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
Uni of Chicago
5801 South Ellis Avenue
Chicago, Illinois 60637
1730
mi
from 91732
Chicago, IL
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Jacksonville Center for Clinical Research
4085 University Blvd S # 1
Jacksonville, Florida 32216
2134
mi
from 91732
Jacksonville, FL
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Borgess Research Institute
1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
1838
mi
from 91732
Kalamazoo, MI
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Sentara Medical Group
6161 Kempsville Circle
Norfolk, Virginia 23502
(757) 261-4986
2342
mi
from 91732
Norfolk, VA
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Spartanburg Medical Research
485 Simuel Road.
Spartanburg, South Carolina 29303
(864) 583-1556
2040
mi
from 91732
Spartanburg, SC
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Center for Rheumatology
Albany, New York 12206
2439
mi
from 91732
Albany, NY
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Aamr Research Clinic
Amarillo, Texas 79106
?
mi
from 91732
Amarillo, TX
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Amarillo Center for Clinical Research
Amarillo, Texas 79124
922
mi
from 91732
Amarillo, TX
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Clinsite;Research Division of Integrated Health Associates
Ann Arbor, Michigan 48106
?
mi
from 91732
Ann Arbor, MI
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Pinnacle Research Group; Llc, Central
321 East 10th Street
Anniston, Alabama 36207
1839
mi
from 91732
Anniston, AL
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The Arthritis Clinic of Northern Virginia, PA
Arlington, Virginia 22205
2278
mi
from 91732
Arlington, VA
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Asheville Arthritis & Osteoporosis Center, PA
4 Vanderbilt Park Drive
Asheville, North Carolina 28803
2003
mi
from 91732
Asheville, NC
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Atlanta Center for Clinical Research
Atlanta, Georgia 30342
1918
mi
from 91732
Atlanta, GA
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University of Colorado Cancer Center
Aurora, Colorado 80045
825
mi
from 91732
Aurora, CO
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Austin Rheumatology Research PA
Austin, Texas 78705
1212
mi
from 91732
Austin, TX
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Walter F. Chase
Austin, Texas 78705
1213
mi
from 91732
Austin, TX
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Arthritis & Rheumatism; Disease Specialities
21097 Northeast 27th Court
Aventura, Florida 33180
2319
mi
from 91732
Aventura, FL
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Johns Hopkins University; Department of Rheumatology
Baltimore, Maryland 21224
?
mi
from 91732
Baltimore, MD
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The Baton Rouge Clinic, AMC
Baton Rouge, Louisiana 70808
1582
mi
from 91732
Baton Rouge, LA
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Arthritis Associates
Belmont, North Carolina 28012
?
mi
from 91732
Belmont, NC
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Bend Memorial Clinic
Bend, Oregon 97701
714
mi
from 91732
Bend, OR
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East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18015
2363
mi
from 91732
Bethlehem, PA
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Rheumatology Associates, PC
Birmingham, Alabama 35205
1785
mi
from 91732
Birmingham, AL
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St. Alexius Medical Center; Arthritis Clinic
310 North 10th Street
Bismarck, North Dakota 58501
1257
mi
from 91732
Bismarck, ND
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'Intermountain Orthopaedics
Boise, Idaho 83702
666
mi
from 91732
Boise, ID
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Arthritis & Osteoporosis Center
186 Joralemon Street
Brooklyn, New York 11201
2433
mi
from 91732
Brooklyn, NY
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Organizacion Medica de Investigacion
725 Uruguay
Buenos Aires, C1015ABO
6112
mi
from 91732
Buenos Aires,
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Arthritis & Osteoporosis Center P.C.
Camden, Connecticut 06510
?
mi
from 91732
Camden, CT
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Physician's Clinic of Iowa, P.C.
Cedar Rapids, Iowa 52401
1526
mi
from 91732
Cedar Rapids, IA
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Low Country Research Center
Charleston, South Carolina 29406
2176
mi
from 91732
Charleston, SC
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Metrolina Medical Research
1700 Abbey Place
Charlotte, North Carolina 28209
2102
mi
from 91732
Charlotte, NC
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Carolina Bone and Joint
Charlotte, North Carolina 29425
2184
mi
from 91732
Charlotte, NC
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Deaconess Arthritis Center; Rheumatic Disease Study Group
Cincinnati, Ohio 45219
?
mi
from 91732
Cincinnati, OH
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University Hospitals at Case Medical Center
Cleveland, Ohio 44194
2033
mi
from 91732
Cleveland, OH
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Coeur D'Alene Arthritis Clinic
Coeur D'Alene, Idaho 83814
941
mi
from 91732
Coeur D'Alene, ID
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Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado 80920
802
mi
from 91732
Colorado Springs, CO
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Csi Research, Inc.
Cumming, Georgia 30041
?
mi
from 91732
Cumming, GA
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Arthritis Care and Diagnostic Center
Dallas, Texas 75321
1224
mi
from 91732
Dallas, TX
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Arthritis Care and Research Centre
Dallas, Texas 75231
?
mi
from 91732
Dallas, TX
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Metroplex Clinical Research
Dallas, Texas 75231
1224
mi
from 91732
Dallas, TX
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Arthritis Centers of Texas
Dallas, Texas
1224
mi
from 91732
Dallas, TX
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Uni of Texas Southwestern Medical Center; Internal Medicine
Dallas, Texas 75390
?
mi
from 91732
Dallas, TX
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STAT Research, Inc.
Dayton, Ohio 45417
1894
mi
from 91732
Dayton, OH
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Seacoast Arthritis and Osteoporosis Center
Dover, New Hampshire 03820
?
mi
from 91732
Dover, NH
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St Luke's Whiteside Research
Duluth, Minnesota 55805
?
mi
from 91732
Duluth, MN
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St. Mary'S Duluth Clinic Health System; Rheumatology Dept
Duluth, Minnesota 55805
?
mi
from 91732
Duluth, MN
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St. Paul Rheumatology, PA
Eagan, Minnesota 55121
1511
mi
from 91732
Eagan, MN
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Center for Arthritis and Osteoporosis
Elizabethtown, Kentucky 42701
?
mi
from 91732
Elizabethtown, KY
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Arthritis Associates
Erie, Pennsylvania 16508
2116
mi
from 91732
Erie, PA
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Rheumatology Associates of NW Pa
Erie, Pennsylvania 16508
?
mi
from 91732
Erie, PA
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Pro Research
Eugene, Oregon 97401
740
mi
from 91732
Eugene, OR
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Evanston Northwestern Healthcare; Rheumatology
Evanston, Illinois 60201
?
mi
from 91732
Evanston, IL
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David S. Rosenberg, M.D
Florissant, Missouri 63031
1567
mi
from 91732
Florissant, MO
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Jackson Arthritis Clinic
4436 Mangum Drive
Flowood, Mississippi 39232
1612
mi
from 91732
Flowood, MS
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Palmetto Clinical Trial Services Llc
Fountain Inn, South Carolina 29644
2031
mi
from 91732
Fountain Inn, SC
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Rheumatic Disease Center
Glendale, Wisconsin 53217
1728
mi
from 91732
Glendale, WI
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Physician's East
Greenville, North Carolina 27834
2290
mi
from 91732
Greenville, NC
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Mark Fisher Md, Facr, Llc
Haddon Heights, New Jersey 08035
?
mi
from 91732
Haddon Heights, NJ
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Unifour Medical Research Associates
Hickory Grove, South Carolina 28602
?
mi
from 91732
Hickory Grove, SC
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CHI St. Vincent Medical Group Hot Springs
Hot Springs, Arkansas 71913
1422
mi
from 91732
Hot Springs, AR
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
1784
mi
from 91732
Huntsville, AL
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Iu Outpatient Clinical Research Facility
Indianapolis, Indiana 46202
?
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from 91732
Indianapolis, IN
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Diagnostic Rheumatology and Research PC
Indianapolis, Indiana 46227
1793
mi
from 91732
Indianapolis, IN
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West Tennessee Research Institute
Jackson, Tennessee 38305
1653
mi
from 91732
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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from 91732
Kansas City, KS
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Rheumatology Consultants Pllc
Knoxville, Tennessee 37909
1918
mi
from 91732
Knoxville, TN
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Allergy & Rheumatology Centre
La Jolla, California 92037
?
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from 91732
La Jolla, CA
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Portland Rheumatology Clinic, Llc
Lake Oswego, Oregon 97035
821
mi
from 91732
Lake Oswego, OR
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Fiechtner Research, Inc.
Lansing, Michigan 48910
1893
mi
from 91732
Lansing, MI
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Rheumatolgy Consultants of Deleware
1532 Savannah Road
Lewes, Delaware 19958
2382
mi
from 91732
Lewes, DE
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Bluegrass Comm Research, Inc.
470 Cooper Drive
Lexington, Kentucky 40515
1881
mi
from 91732
Lexington, KY
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Little Rock Diagnostic Clinic
Little Rock, Arkansas 72205
1460
mi
from 91732
Little Rock, AR
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Private Practice
Long Beach, California 90808
?
mi
from 91732
Long Beach, CA
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Valerius Medical Group & Research Ctr of Greater Long Beach
10861 Cherry Street
Los Alamitos, California 90720
18
mi
from 91732
Los Alamitos, CA
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Uni of Southern California School of Medicine
Los Angeles, California 90033
?
mi
from 91732
Los Angeles, CA
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Pacific Arthritis Care Center
Los Angeles, California 90045
13
mi
from 91732
Los Angeles, CA
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Kentuckiana Center For Better Bone & Joint Healthx
Louisville, Kentucky 40202
?
mi
from 91732
Louisville, KY
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Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas 79424
923
mi
from 91732
Lubbock, TX
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Marietta Rheumatology Associates
Marietta, Georgia 30060
1908
mi
from 91732
Marietta, GA
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David Mandel Inc
Mayfield, Ohio 44143
?
mi
from 91732
Mayfield, OH
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The Arthritis Group, Pc
Memphis, Tennessee 38104
1589
mi
from 91732
Memphis, TN
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Ramesh Gupta
Memphis, Tennessee 38119
1586
mi
from 91732
Memphis, TN
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Idaho Arthritis Center
Meridian, Idaho
664
mi
from 91732
Meridian, ID
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Arizona Arthritis & Rheumatology Research, PLLC
Mesa, Arizona 85202
355
mi
from 91732
Mesa, AZ
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Arthrocare, Arthritis Care and Research, P.C.
Mesa, Arizona 85208
?
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from 91732
Mesa, AZ
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Southwest Rheumatology, PA
Mesquite, Texas 75150
1233
mi
from 91732
Mesquite, TX
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Paramount Medical Research
Middleburg Heights, Ohio 44130
2025
mi
from 91732
Middleburg Heights, OH
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Park Nicollet Inst. ; Rtrc
Minneapolis, Minnesota 55416
?
mi
from 91732
Minneapolis, MN
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Quad City Rheumatology, Sc
Moline, Illinois 61265
?
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from 91732
Moline, IL
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Illinois Bone & Joint Inst.
Morton Grove, Illinois 60053
?
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from 91732
Morton Grove, IL
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Medical Specialists Clinical Research Center
Munster, Indiana 46321
?
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from 91732
Munster, IN
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Nashua Rheumatology - Foundation Medical Partners
Nashua, New Hampshire 03060
2556
mi
from 91732
Nashua, NH
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Javed Rheumatology Associates
Newark, Delaware 19713
2345
mi
from 91732
Newark, DE
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Medical Uni of South Carolina
171 Ashley Avenue
North Charleston, South Carolina 29425
2184
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from 91732
North Charleston, SC
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Health Research of Oklahoma
Oklahoma City, Oklahoma 73103
1165
mi
from 91732
Oklahoma City, OK
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Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
1165
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from 91732
Oklahoma City, OK
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Southern Tier Arthritis and Rheumatism
Olean, New York 14760
2201
mi
from 91732
Olean, NY
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Westroads Medical Group
Omaha, Nebraska 68114
1295
mi
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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
1582
mi
from 91732
Onalaska, WI
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Arthritis Center Palm Harbor
32615 US Highway 19 North
Palm Harbor, Florida 34684
2117
mi
from 91732
Palm Harbor, FL
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