A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics



Status:Terminated
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 75
Updated:9/7/2018
Start Date:August 2012
End Date:November 2014

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A Randomised, Double Blind, Placebo-controlled, Multiple Dose, Phase 2b, 24 Week Trial Followed by an Open Label Extension of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics

This trial is conducted in Europe, North America and South America. The aim of this trial is
to investigate the clinical efficacy of NNC0109-0012, a human monoclonal antibody, compared
to placebo when administered as weekly s.c. (subcutaneous, under the skin) injections to
patients with active rheumatoid arthritis (RA) who are inadequate responders to anti-TNFa
biologics and are on a stable background of methotrexate (MTX) therapy.


Inclusion Criteria:

- Informed consent must be obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial, including
activities to determine suitability for the trial.

- A documented diagnosis of RA at least 6 months prior to screening visit, according to
the American College of Rheumatology (EULAR/ACR 2010 criteria) or by standard criteria
(ACR 1987) if diagnosis was made earlier than 2010

- Active RA, characterised by: a. above 5 tender and above 5 swollen joints based on a
28 joint count b. CRP (C-reactive protein) above or equal to 1.0 mg/dL (10 mg/L)

- Patients must be anti-TNF (anti-Tumour Necrosis Factor) inadequate responders to at
least one but not more than two anti-TNF biologics with active disease documented in
medical records at the time of discontinuation

Exclusion Criteria:

- Patients with arthritis due to other autoimmune diseases than RA

- Any active or ongoing bacterial infections within 4 weeks prior to screening visit,
unless treated and resolved with appropriate therapy or any history of recurrent
infections or conditions predisposing to chronic infections (e.g., bronchiectasis,
chronic osteomyelitis)

- History of severe, systemic viral or fungal infections within the past 6 months prior
to screening visit, unless treated and/or resolved with appropriate therapy

- Patients with active malignancy within the previous 5 years with the exception of
adequately treated and cured basal or squamous cell carcinoma of the skin or cervical
carcinoma in situ occurring more than 12 months prior to screening visit

- Females of childbearing potential who are pregnant or breast feeding or intend to
become pregnant

- Any other disease or clinically significant abnormality in laboratory parameters
which, according to the Investigator, might compromise the safety of the patient,
interfere with participation in the trial or compromise the trial objective
We found this trial at
85
sites
Elizabethtown, Kentucky 42701
1954
mi
from 98109
Elizabethtown, KY
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Albany, New York 12208
2351
mi
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Albany, NY
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Albuquerque, New Mexico 87102
1184
mi
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Albuquerque, NM
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Amarillo, Texas 79106
1358
mi
from 98109
Amarillo, TX
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Ann Arbor, Michigan 48106
1902
mi
from 98109
Ann Arbor, MI
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Arlington, Virginia 22206
2319
mi
from 98109
Arlington, VA
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Austin, Texas 78731
1770
mi
from 98109
Austin, TX
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Baltimore, Maryland 21229
2325
mi
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Baltimore, MD
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Battle Creek, Michigan 49018
?
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Battle Creek, MI
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Beckley, West Virginia 25801
2168
mi
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Beckley, WV
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251
mi
from 98109
Bend, OR
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Boca Raton, Florida 33433
2708
mi
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Boca Raton, FL
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Brooklyn, New York 11215
2129
mi
from 98109
Brooklyn, NY
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?
mi
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Buenos Aires,
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Carrollton, Texas 75007
1665
mi
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Carrollton, TX
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Cedar Rapids, Iowa 52401
1542
mi
from 98109
Cedar Rapids, IA
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Chapel Hill, North Carolina 27599
2337
mi
from 98109
Chapel Hill, NC
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Charleston, South Carolina 29407
2419
mi
from 98109
Charleston, SC
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Charlotte, North Carolina 28277
2281
mi
from 98109
Charlotte, NC
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Cincinnati, Ohio 45229
1966
mi
from 98109
Cincinnati, OH
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Clifton, New Jersey 07012
?
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Clifton, NJ
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920 Massachusetts Avenue Northwest
Columbia, Maryland 21045
2322
mi
from 98109
Columbia, MD
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Columbia, South Carolina 29203
2322
mi
from 98109
Columbia, SC
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Columbus, Ohio 43205
2008
mi
from 98109
Columbus, OH
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Cumberland, Maryland 21502
?
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Cumberland, MD
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Decatur, Georgia 30033
2182
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Decatur, GA
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Flowood, Mississippi 39232
?
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Flowood, MS
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Fort Lauderdale, Florida 33316
2719
mi
from 98109
Fort Lauderdale, FL
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800 Scudders Mill Road
Freehold, New Jersey 07728
2386
mi
from 98109
Freehold, NJ
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Gainesville, Florida 32608
2453
mi
from 98109
Gainesville, FL
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Glendale, California 91206
955
mi
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Glendale, CA
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Greensboro, North Carolina 27408
2297
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from 98109
Greensboro, NC
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Hagerstown, Maryland 21740
2265
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Hagerstown, MD
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Hemet, California 92543
?
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Hemet, CA
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Hershey, Pennsylvania 17033
2293
mi
from 98109
Hershey, PA
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Houston, Texas 77030
1892
mi
from 98109
Houston, TX
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Huntington Beach, California 92648
991
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from 98109
Huntington Beach, CA
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Huntsville, Alabama 35801
2038
mi
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Huntsville, AL
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Idaho Falls, Idaho 83404
577
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Idaho Falls, ID
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Jackson, Tennessee 38305
1900
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Jackson, TN
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Jupiter, Florida 33468
?
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Jupiter, FL
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Kansas City, Kansas 66160
1500
mi
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Kansas City, KS
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La Mesa, California 91942
1064
mi
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La Mesa, CA
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Lake Charles, Louisiana 70601
1953
mi
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Lake Charles, LA
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Lake Oswego, Oregon 07035
?
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Lake Oswego, OR
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Lake Success, New York 11042
2413
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Lake Success, NY
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Lakewood, California 90712
?
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Lakewood, CA
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Lincoln, Nebraska 68502
1347
mi
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Lincoln, NE
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Long Beach, California 90807
977
mi
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Long Beach, CA
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Los Angeles, California 90027
956
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Los Angeles, CA
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McKinney, Texas 75071
?
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McKinney, TX
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Memphis, Tennessee 38119
1876
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Memphis, TN
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Mesa, Arizona 85206
1124
mi
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Mesa, AZ
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New Port Richey, Florida 34652
2501
mi
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New Port Richey, FL
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Norman, Oklahoma 73069
1538
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from 98109
Norman, OK
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Ocala, Florida 34471
2485
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Ocala, FL
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Oklahoma City, Oklahoma 73112
1523
mi
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Oklahoma City, OK
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Orangeburg, South Carolina 29118
2351
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Orangeburg, SC
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Orlando, Florida 32804
2544
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Orlando, FL
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Phoenix, Arizona 85053
1116
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Phoenix, AZ
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Placentia, California 92870
978
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Placentia, CA
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Raleigh, North Carolina 27610
2362
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from 98109
Raleigh, NC
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Rock Island, Illinois 61201
1607
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Rock Island, IL
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Saint Louis, Missouri 63110
1721
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Saint Louis, MO
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San Diego, California 92111
1065
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San Diego, CA
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Santa Monica, California 90404
961
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Santa Monica, CA
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Scottsdale, Arizona 85258
?
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Scottsdale, AZ
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Seattle, Washington 98105
2
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Seattle, WA
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Shreveport, Louisiana 71105
1825
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Shreveport, LA
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South Bend, Indiana 46601
1803
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South Bend, IN
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Springfield, Illinois 62702
1705
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Springfield, IL
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Sugar Land, Texas 77479
1887
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Sugar Land, TX
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Tacoma, Washington 98405
26
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Tacoma, WA
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Tampa, Florida 33612
2522
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Tampa, FL
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1927
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Toledo, OH
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Toms River, New Jersey 08755
2418
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Toms River, NJ
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Tulsa, Oklahoma 74135
1558
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Tulsa, OK
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Tuscaloosa, Alabama 35406
2058
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Tuscaloosa, AL
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Upland, California 91786
965
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Upland, CA
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Venice, Florida 34292
?
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Venice, FL
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1726
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Waco, TX
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West Palm Beach, Florida 33409
2692
mi
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West Palm Beach, FL
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Wichita, Kansas 67205
1435
mi
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Wichita, KS
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Wilmington, North Carolina 28401
2455
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Wilmington, NC
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Worcester, Massachusetts 01655
2454
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Worcester, MA
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