A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics
NCT ID: NCT01636817
Last Updated: 2018-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
239 participants
INTERVENTIONAL
2012-08-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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60 mg
NNC0109-0012
Administered subcutaneously (s.c., under the skin) once weekly.
120 mg
NNC0109-0012
Administered subcutaneously (s.c., under the skin) once weekly.
240 mg
NNC0109-0012
Administered subcutaneously (s.c., under the skin) once weekly.
Placebo
placebo
Administered subcutaneously (s.c., under the skin) once weekly.
Interventions
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NNC0109-0012
Administered subcutaneously (s.c., under the skin) once weekly.
placebo
Administered subcutaneously (s.c., under the skin) once weekly.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Huntsville, Alabama, United States
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Tuscaloosa, Alabama, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Glendale, California, United States
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Hemet, California, United States
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Huntington Beach, California, United States
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La Mesa, California, United States
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Lakewood, California, United States
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Long Beach, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Placentia, California, United States
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San Diego, California, United States
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Santa Monica, California, United States
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Upland, California, United States
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Boca Raton, Florida, United States
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Fort Lauderdale, Florida, United States
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Gainesville, Florida, United States
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Jupiter, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Orlando, Florida, United States
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Tampa, Florida, United States
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Venice, Florida, United States
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West Palm Beach, Florida, United States
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Decatur, Georgia, United States
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Idaho Falls, Idaho, United States
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Rock Island, Illinois, United States
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Springfield, Illinois, United States
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South Bend, Indiana, United States
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Cedar Rapids, Iowa, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Elizabethtown, Kentucky, United States
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Lake Charles, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Columbia, Maryland, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Worcester, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Battle Creek, Michigan, United States
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Flowood, Mississippi, United States
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Flowood, Mississippi, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Lincoln, Nebraska, United States
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Clifton, New Jersey, United States
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Freehold, New Jersey, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
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Brooklyn, New York, United States
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Lake Success, New York, United States
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Chapel Hill, North Carolina, United States
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Charlotte, North Carolina, United States
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Greensboro, North Carolina, United States
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Raleigh, North Carolina, United States
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Wilmington, North Carolina, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Toledo, Ohio, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bend, Oregon, United States
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Lake Oswego, Oregon, United States
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Hershey, Pennsylvania, United States
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Charleston, South Carolina, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Orangeburg, South Carolina, United States
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Jackson, Tennessee, United States
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Memphis, Tennessee, United States
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Memphis, Tennessee, United States
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Amarillo, Texas, United States
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Austin, Texas, United States
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Carrollton, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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McKinney, Texas, United States
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Sugar Land, Texas, United States
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Waco, Texas, United States
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Arlington, Virginia, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Beckley, West Virginia, United States
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Ciudad Autonoma de Buenos Aire, , Argentina
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Ciudad de Buenos Aires, , Argentina
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Córdoba, , Argentina
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Rosario, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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Anderlecht, , Belgium
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Kortrijk, , Belgium
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Liège, , Belgium
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Saint Oeste, Goiás, Brazil
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Juiz de Fora, Minas Gerais, Brazil
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Santa Efigenia-Belo Horizonte, Minas Gerais, Brazil
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São Paulo, São Paulo, Brazil
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Vila Clementino, São Paulo, Brazil
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Vila Clementino, São Paulo, Brazil
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Cuiabá - Mount, , Brazil
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Curitiba, , Brazil
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Rio Grande de Sul, , Brazil
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São Paulo, , Brazil
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Hlučín, , Czechia
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Prague, , Czechia
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Zlín, , Czechia
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Bois-Guillaume, , France
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Bordeaux, , France
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Échirolles, , France
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Lyon, , France
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Nantes, , France
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Orléans, , France
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Rennes, , France
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Bad Kreuznach, , Germany
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Frankfurt, , Germany
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Hamburg, , Germany
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Herne, , Germany
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Koein, , Germany
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Vogelsang-Gommern, , Germany
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Debrecen, , Hungary
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Veszprém, , Hungary
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Arenzano, , Italy
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Florence, , Italy
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Genova, , Italy
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Iesi, , Italy
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Rome, , Italy
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Torrette Di Ancona, , Italy
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Verona, , Italy
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Guadalajara, Jalisco, Mexico
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Mexico City, México, D.F., Mexico
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Monterrey, Nuevo León, Mexico
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Culiacán, Sinaloa, Mexico
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Chihuahua City, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Monterrey N.L., , Mexico
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Roma, , Mexico
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San Luis Potosí City, , Mexico
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Krakow, , Poland
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Poznan, , Poland
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Środa Wielkopolska, , Poland
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Guadalajara, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Seville, , Spain
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Seville, , Spain
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Valencia, , Spain
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Barnsley, , United Kingdom
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Eastbourne, , United Kingdom
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Maidstone, , United Kingdom
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Sheffield, , United Kingdom
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Wolverhampton, , United Kingdom
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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2012-000609-58
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1127-9273
Identifier Type: OTHER
Identifier Source: secondary_id
NN8226-3612
Identifier Type: -
Identifier Source: org_study_id
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