Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/26/2018
Start Date:June 2012
End Date:June 2015

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A Phase IIb, Randomized, Multi-Center, Double-Blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Clazakizumab in Subjects With Moderate to Severe Active Rheumatoid Arthritis Who Have Experienced an Inadequate Response to TNF Inhibitors

The primary purpose of this study is to identify an appropriate dose of study medication.


For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com

Inclusion Criteria:

- Diagnosis of active Rheumatoid Arthritis (RA) by standard criteria (American
Rheumatism association (ARA) [1987] or American College of Rheumatology/European
League Against Rheumatism (ACR/EULAR) [2010]) at least 16 weeks prior to screening

- ACR global functional status class of 1 to 3

- Documented evidence of inadequate response tumor necrosis factor (TNF) inhibitors

- All subjects must have been receiving treatment with a minimum dose of 15 mg per week
of Methotrexate for at least 12 weeks and at a stable dose for 28 days prior to
screening. A dose as low as 10 mg Methotrexate is permitted if 15 mg could not be
reached, due to toxicity. In Japan, Korea and Taiwan, a minimum dose of 7.5 mg per
week is permitted. Additional treatment with Hydroxychloroquine or Chloroquine is
permitted, if it is at a dose approved for the treatment of RA and the dose has been
stable for at least 28 days prior to screening

- Minimum of 6 swollen and 6 tender joints on a 66/68 joint count at screening and at
baseline (Day 1)

- Elevated High-sensitivity (hs) CRP and/or ESR

Exclusion Criteria:

- Active serious infection

- History of or active tuberculosis (TB)

- Elevated liver function tests (LFTs)
We found this trial at
22
sites
Knoxville, Tennessee 37909
2106
mi
from 98109
Knoxville, TN
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Albuquerque, New Mexico 87102
1184
mi
from 98109
Albuquerque, NM
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Albuquerque, New Mexico
1184
mi
from 98109
Albuquerque, NM
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Charleston, South Carolina 29406
2423
mi
from 98109
Charleston, SC
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2282
mi
from 98109
Charlotte, NC
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1966
mi
from 98109
Cincinnati, OH
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Eagan, Minnesota 55121
1399
mi
from 98109
Eagan, MN
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Greenville, North Carolina 27834
2426
mi
from 98109
Greenville, NC
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Hot Springs, Arkansas 71913
1759
mi
from 98109
Hot Springs, AR
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2038
mi
from 98109
Huntsville, AL
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Lincoln, Nebraska 68512
1346
mi
from 98109
Lincoln, NE
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979
mi
from 98109
Long Beach, CA
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Middleburg Heights, Ohio 44130
2019
mi
from 98109
Middleburg Heights, OH
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Nashville, Tennessee 37203
1971
mi
from 98109
Nashville, TN
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Oklahoma City, Oklahoma 73103
1522
mi
from 98109
Oklahoma City, OK
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Oklahoma City, Oklahoma 73103
1522
mi
from 98109
Oklahoma City, OK
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Palm Desert, California 92260
1010
mi
from 98109
Palm Desert, CA
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Quilmes, Buenos Aires
6929
mi
from 98109
Quilmes,
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Sarasota, Florida 34239
2552
mi
from 98109
Sarasota, FL
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Seattle, Washington 98104
2
mi
from 98109
Seattle, WA
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Tulsa, Oklahoma 74135
1564
mi
from 98109
Tulsa, OK
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Worcester, Massachusetts 01610
2454
mi
from 98109
Worcester, MA
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