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
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Charlotte, North Carolina 28277
348
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Charlotte, NC
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Albany, New York 12208
513
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Albany, NY
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Albuquerque, New Mexico 87102
1333
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Albuquerque, NM
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Amarillo, Texas 79106
1078
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Amarillo, TX
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Ann Arbor, Michigan 48106
164
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Ann Arbor, MI
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Arlington, Virginia 22206
324
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Arlington, VA
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Austin, Texas 78731
1065
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Austin, TX
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Baltimore, Maryland 21229
340
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Baltimore, MD
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Battle Creek, Michigan 49018
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Beckley, West Virginia 25801
180
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Beckley, WV
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1967
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Bend, OR
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Boca Raton, Florida 33433
955
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Boca Raton, FL
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Brooklyn, New York 11215
280
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Brooklyn, NY
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?
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Buenos Aires,
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Carrollton, Texas 75007
906
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Carrollton, TX
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Cedar Rapids, Iowa 52401
471
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Cedar Rapids, IA
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Chapel Hill, North Carolina 27599
353
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Chapel Hill, NC
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Charleston, South Carolina 29407
522
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Charleston, SC
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Cincinnati, Ohio 45229
95
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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
328
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Columbia, MD
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Columbia, South Carolina 29203
426
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Columbia, SC
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Columbus, Ohio 43205
1
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Columbus, OH
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Cumberland, Maryland 21502
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Cumberland, MD
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Decatur, Georgia 30033
433
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Decatur, GA
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Elizabethtown, Kentucky 42701
218
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Elizabethtown, KY
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Flowood, Mississippi 39232
?
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Flowood, MS
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Fort Lauderdale, Florida 33316
972
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Fort Lauderdale, FL
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800 Scudders Mill Road
Freehold, New Jersey 07728
445
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Freehold, NJ
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Gainesville, Florida 32608
716
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Gainesville, FL
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Glendale, California 91206
1970
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Glendale, CA
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Greensboro, North Carolina 27408
321
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Greensboro, NC
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Hagerstown, Maryland 21740
282
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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
337
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Hershey, PA
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Houston, Texas 77030
995
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Houston, TX
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Huntington Beach, California 92648
1969
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Huntsville, Alabama 35801
411
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Huntsville, AL
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Idaho Falls, Idaho 83404
1506
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Idaho Falls, ID
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Jackson, Tennessee 38305
436
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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
620
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La Mesa, California 91942
1942
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Lake Charles, Louisiana 70601
885
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Lake Oswego, Oregon 07035
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Lake Oswego, OR
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Lake Success, New York 11042
492
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Lakewood, California 90712
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Lincoln, Nebraska 68502
721
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Lincoln, NE
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Long Beach, California 90807
1974
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Long Beach, CA
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Los Angeles, California 90027
1973
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McKinney, Texas 75071
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Memphis, Tennessee 38119
503
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Mesa, Arizona 85206
1650
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Mesa, AZ
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New Port Richey, Florida 34652
809
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Norman, Oklahoma 73069
853
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Norman, OK
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Ocala, Florida 34471
748
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Oklahoma City, Oklahoma 73112
849
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Orangeburg, South Carolina 29118
463
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Orlando, Florida 32804
792
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Phoenix, Arizona 85053
1662
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Placentia, California 92870
1956
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Raleigh, North Carolina 27610
375
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Rock Island, Illinois 61201
408
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Saint Louis, Missouri 63110
394
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San Diego, California 92111
1951
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Santa Monica, California 90404
1984
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Scottsdale, Arizona 85258
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Seattle, Washington 98105
2006
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Shreveport, Louisiana 71105
788
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South Bend, Indiana 46601
205
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Springfield, Illinois 62702
349
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Sugar Land, Texas 77479
1009
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Tacoma, Washington 98405
2012
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Tampa, Florida 33612
823
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117
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Toledo, OH
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Toms River, New Jersey 08755
467
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Tulsa, Oklahoma 74135
752
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Tuscaloosa, Alabama 35406
530
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Upland, California 91786
1940
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Venice, Florida 34292
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983
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Waco, TX
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West Palm Beach, Florida 33409
931
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Wichita, Kansas 67205
785
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Wilmington, North Carolina 28401
485
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Worcester, Massachusetts 01655
604
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Worcester, MA
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