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
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New Port Richey, Florida 34652
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Albany, New York 12208
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Albuquerque, New Mexico 87102
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Amarillo, Texas 79106
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Ann Arbor, Michigan 48106
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Arlington, Virginia 22206
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Austin, Texas 78731
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Baltimore, Maryland 21229
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Battle Creek, Michigan 49018
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Beckley, West Virginia 25801
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Boca Raton, Florida 33433
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Brooklyn, New York 11215
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Buenos Aires,
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Carrollton, Texas 75007
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Cedar Rapids, Iowa 52401
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Chapel Hill, North Carolina 27599
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Charleston, South Carolina 29407
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Charlotte, North Carolina 28277
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Cincinnati, Ohio 45229
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Clifton, New Jersey 07012
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920 Massachusetts Avenue Northwest
Columbia, Maryland 21045
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Columbia, South Carolina 29203
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Columbus, Ohio 43205
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Cumberland, Maryland 21502
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Decatur, Georgia 30033
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Elizabethtown, Kentucky 42701
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Flowood, Mississippi 39232
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Fort Lauderdale, Florida 33316
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800 Scudders Mill Road
Freehold, New Jersey 07728
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Gainesville, Florida 32608
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Glendale, California 91206
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Greensboro, North Carolina 27408
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Hagerstown, Maryland 21740
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Hemet, California 92543
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Hershey, Pennsylvania 17033
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Houston, Texas 77030
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Huntington Beach, California 92648
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Huntsville, Alabama 35801
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Idaho Falls, Idaho 83404
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Jackson, Tennessee 38305
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Jupiter, Florida 33468
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Kansas City, Kansas 66160
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La Mesa, California 91942
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Lake Charles, Louisiana 70601
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Lake Oswego, Oregon 07035
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Lake Success, New York 11042
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Lakewood, California 90712
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Lincoln, Nebraska 68502
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Long Beach, California 90807
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Los Angeles, California 90027
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McKinney, Texas 75071
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Memphis, Tennessee 38119
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Mesa, Arizona 85206
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Norman, Oklahoma 73069
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Ocala, Florida 34471
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Oklahoma City, Oklahoma 73112
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Orangeburg, South Carolina 29118
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Orlando, Florida 32804
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Placentia, California 92870
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Raleigh, North Carolina 27610
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Rock Island, Illinois 61201
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Saint Louis, Missouri 63110
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Shreveport, Louisiana 71105
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South Bend, Indiana 46601
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Springfield, Illinois 62702
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Sugar Land, Texas 77479
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Tacoma, Washington 98405
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Tampa, Florida 33612
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Toms River, New Jersey 08755
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Tulsa, Oklahoma 74135
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Tuscaloosa, Alabama 35406
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Upland, California 91786
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Venice, Florida 34292
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West Palm Beach, Florida 33409
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Wichita, Kansas 67205
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Wilmington, North Carolina 28401
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Worcester, Massachusetts 01655
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