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

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ClinicalTrials.gov Identifier: NCT01636843
Recruitment Status : Terminated
First Posted : July 10, 2012
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 repeat subcutaneous (under the skin) injections in to patients with active rheumatoid arthritis (RA) with inadequate responses to methotrexate (MTX) while on a stable background of MTX therapy.

Condition or disease Intervention/treatment Phase
Inflammation Rheumatoid Arthritis Drug: NNC0109-0012 Drug: placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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 Methotrexate
Actual Study Start Date : October 30, 2012
Actual Primary Completion Date : November 10, 2014
Actual Study Completion Date : November 10, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 60 mg Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly.

Experimental: 120 mg Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly.

Experimental: 240 mg Drug: NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly.

Experimental: Placebo Drug: placebo
Administered subcutaneously (s.c., under the skin), once weekly.




Primary Outcome Measures :
  1. ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) [ Time Frame: At week 12 (responder or non-responder) ]

Secondary Outcome Measures :
  1. ACR20, ACR50 and ACR70 improvement of ACR score from baseline [ Time Frame: At weeks 12 and 24 ]
  2. Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline [ Time Frame: At weeks 12 and 24 ]
  3. Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below) [ Time Frame: At weeks 12 and 24 ]
  4. European League Against Rheumatism (EULAR) criteria response [ Time Frame: At weeks 12 and 24 ]
  5. Change from baseline in the overall scores of Short Form Health Survey (SF-36v2) [ Time Frame: At weeks 12 and 24 ]
  6. Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI) [ Time Frame: At weeks 12 and 24 ]
  7. Incidence and type of adverse events (AEs) [ Time Frame: At weeks 12 and 24 ]
  8. Change from baseline in van der Heijde modified Sharp score [ Time Frame: At weeks 12 and 24 ]
  9. ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [ Time Frame: Week 52 ]
  10. Incidence and type of adverse events (AEs) [ Time Frame: Week 52 ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
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. more than 5 tender and more than 5 swollen joints based on a 28 joint count b. C-reactive protein (CRP) above or equal to 1.0 mg/dL (10 mg/L) - Patients can be on methotrexate with or without hydroxychloroquine/chloroquine: a. Methotrexate treatment (above or equal to 15.0 mg/week) for at least 16 weeks, (above or equal to 15.0 mg/week to below or equal to 25 mg/week) for at least 8 weeks prior to screening. Patient can be on MTX as low as 10 mg/week only if due to MTX intolerance b. Hydroxychloroquine (200-400 mg/day per os, oral dosing (p.o.)) or chloroquine (250-500 mg/day p.o.) treatment for at least 8 weeks prior to screening visit 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636843


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Locations
United States, California
Novo Nordisk Investigational Site
Huntington Beach, California, United States, 92646
Novo Nordisk Investigational Site
La Mesa, California, United States, 91942
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90022
Novo Nordisk Investigational Site
Placentia, California, United States, 92870
Novo Nordisk Investigational Site
Upland, California, United States, 91786
United States, Florida
Novo Nordisk Investigational Site
Palm Harbor, Florida, United States, 34684
United States, Illinois
Novo Nordisk Investigational Site
Rock Island, Illinois, United States, 61201
Novo Nordisk Investigational Site
Springfield, Illinois, United States, 62704
United States, Indiana
Novo Nordisk Investigational Site
South Bend, Indiana, United States, 46601
United States, Iowa
Novo Nordisk Investigational Site
Cedar Rapids, Iowa, United States, 52401-2112
United States, Kansas
Novo Nordisk Investigational Site
Wichita, Kansas, United States, 67206
United States, Kentucky
Novo Nordisk Investigational Site
Elizabethtown, Kentucky, United States, 42701-2988
United States, Louisiana
Novo Nordisk Investigational Site
Lake Charles, Louisiana, United States, 70601
United States, Maryland
Novo Nordisk Investigational Site
Hagerstown, Maryland, United States, 21740
United States, Missouri
Novo Nordisk Investigational Site
Saint Louis, Missouri, United States, 63117
United States, Montana
Novo Nordisk Investigational Site
Kalispell, Montana, United States, 59901
United States, New Jersey
Novo Nordisk Investigational Site
Freehold, New Jersey, United States, 07728
Novo Nordisk Investigational Site
Toms River, New Jersey, United States, 08755
United States, New Mexico
Novo Nordisk Investigational Site
Albuquerque, New Mexico, United States, 87102
United States, New York
Novo Nordisk Investigational Site
Brooklyn, New York, United States, 11201-4326
Novo Nordisk Investigational Site
Lake Success, New York, United States, 11042
United States, North Carolina
Novo Nordisk Investigational Site
Charlotte, North Carolina, United States, 28210
United States, Oklahoma
Novo Nordisk Investigational Site
Norman, Oklahoma, United States, 73069
United States, South Carolina
Novo Nordisk Investigational Site
Orangeburg, South Carolina, United States, 29118
United States, Tennessee
Novo Nordisk Investigational Site
Jackson, Tennessee, United States, 38305
Novo Nordisk Investigational Site
Memphis, Tennessee, United States, 38119
United States, Texas
Novo Nordisk Investigational Site
Houston, Texas, United States, 77008
Novo Nordisk Investigational Site
Mesquite, Texas, United States, 75150-5615
United States, West Virginia
Novo Nordisk Investigational Site
Beckley, West Virginia, United States, 25801-2805
Argentina
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B 1900AXI
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B1878GEG
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1425DUH
Novo Nordisk Investigational Site
Buenos Aires, Argentina, CA1199ABB
Novo Nordisk Investigational Site
Ciudad Autonoma Buenos Aires, Argentina, 1113
Novo Nordisk Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, Argentina, 1194
Novo Nordisk Investigational Site
Ciudad de Buenos Aires, Argentina, C1204AAD
Novo Nordisk Investigational Site
Rosario City, Argentina, S2000PBJ
Novo Nordisk Investigational Site
San Juan, Argentina, ZC:5400
Novo Nordisk Investigational Site
Tucuman, Argentina, 4000
Novo Nordisk Investigational Site
Tucuman, Argentina, T4000BRD
Belgium
Novo Nordisk Investigational Site
Anderlecht, Belgium, 1070
Novo Nordisk Investigational Site
Kortrijk, Belgium, 8500
Novo Nordisk Investigational Site
Liege, Belgium, 4000
Brazil
Novo Nordisk Investigational Site
Saint Oeste, Goias, Brazil, 74110-120
Novo Nordisk Investigational Site
Juiz de Fora, Minas Gerais, Brazil, 36010-570
Novo Nordisk Investigational Site
Curitiba, Parana, Brazil, 80030-110
Novo Nordisk Investigational Site
São Paulo, Sao Paulo, Brazil, 01244-030
Novo Nordisk Investigational Site
Vila Clementino, Sao Paulo, Brazil, 04026-000
Novo Nordisk Investigational Site
Vila Clementino, Sao Paulo, Brazil, 04032-060
Novo Nordisk Investigational Site
Cuiaba Mount, Brazil, 78040.360
Novo Nordisk Investigational Site
Curitiba, Brazil, 80440-080
Novo Nordisk Investigational Site
Rio de Janeiro, Brazil, 22271-100
Novo Nordisk Investigational Site
Sao Paulo, Brazil, 01323-903
Novo Nordisk Investigational Site
Sao Paulo, Brazil, 04266-010
Novo Nordisk Investigational Site
Sao Paulo, Brazil, 05437-010
Czechia
Novo Nordisk Investigational Site
Brno, Czechia, 602 00
Novo Nordisk Investigational Site
Brno, Czechia, 625 00
Novo Nordisk Investigational Site
Hlucin, Czechia, 748 01
Novo Nordisk Investigational Site
Pardubice, Czechia, 530 02
Novo Nordisk Investigational Site
Prague 3, Czechia, 130 00
Novo Nordisk Investigational Site
Prague 4, Czechia, 14000
Novo Nordisk Investigational Site
Praha 11, Czechia, 148 00
Novo Nordisk Investigational Site
Praha 2, Czechia, 128 50
Novo Nordisk Investigational Site
Zlin, Czechia, 76001
France
Novo Nordisk Investigational Site
Echirolles, France, 38130
Novo Nordisk Investigational Site
Nantes Cedex 01, France, 44093
Novo Nordisk Investigational Site
Orleans, France, 45032
Novo Nordisk Investigational Site
Rennes, France, 35033
Germany
Novo Nordisk Investigational Site
Aachen, Germany, 52064
Novo Nordisk Investigational Site
Bad Kreuznach, Germany, 5543
Novo Nordisk Investigational Site
Frankfurt, Germany, 60528
Novo Nordisk Investigational Site
Hamburg, Germany, 22081
Novo Nordisk Investigational Site
Herne, Germany, 44649
Novo Nordisk Investigational Site
Koein, Germany, D-50937
Novo Nordisk Investigational Site
Vogelsang-Gommern, Germany, 39245
Hungary
Novo Nordisk Investigational Site
Kiskunhalas, Hungary, 6400
Italy
Novo Nordisk Investigational Site
Arenzano, Italy, 16011
Novo Nordisk Investigational Site
Firenze, Italy, 50139
Novo Nordisk Investigational Site
Genova, Italy, 16132
Novo Nordisk Investigational Site
Jesi, Italy, 60035
Novo Nordisk Investigational Site
Rome, Italy, 161
Novo Nordisk Investigational Site
Verona, Italy, 37134
Mexico
Novo Nordisk Investigational Site
Guadalajara, Jalisco, Mexico, 44600
Novo Nordisk Investigational Site
Mexico City, México, D.F., Mexico, 06100
Novo Nordisk Investigational Site
Mexico, México, D.F., Mexico, 06700
Novo Nordisk Investigational Site
Monterrey, Nuevo León, Mexico, 64000
Novo Nordisk Investigational Site
Culiacan, Sinaloa, Mexico, 80230
Novo Nordisk Investigational Site
Chihuahua, Mexico, 31000
Novo Nordisk Investigational Site
Mexico City, Mexico, 03100
Novo Nordisk Investigational Site
Mexico City, Mexico, 07760
Novo Nordisk Investigational Site
Mexico City, Mexico, C.P. 06700
Novo Nordisk Investigational Site
Monterrey N.L., Mexico, 64000
Novo Nordisk Investigational Site
Roma, Mexico, 06700
Novo Nordisk Investigational Site
San Luis Potosi, Mexico, 78200
Poland
Novo Nordisk Investigational Site
Bialystok, Poland, 15-879
Novo Nordisk Investigational Site
Gdynia, Poland, 81-384
Novo Nordisk Investigational Site
Katowice, Poland, 40-040
Novo Nordisk Investigational Site
Krakow, Poland, 30119
Novo Nordisk Investigational Site
Poznan, Poland, 60-218
Novo Nordisk Investigational Site
Sroda Wielkopolska, Poland, 63-000
Novo Nordisk Investigational Site
Warsaw, Poland, 01-868
Novo Nordisk Investigational Site
Warsaw, Poland, 04-141
Novo Nordisk Investigational Site
Wroclaw, Poland, 50-381
Russian Federation
Novo Nordisk Investigational Site
Barnaul, Russian Federation, 656024
Novo Nordisk Investigational Site
Barnaul, Russian Federation, 656055
Novo Nordisk Investigational Site
Ekaterinburg, Russian Federation, 620102
Novo Nordisk Investigational Site
Kemerovo, Russian Federation, 193257
Novo Nordisk Investigational Site
Moscow, Russian Federation, 115522
Novo Nordisk Investigational Site
Moscow, Russian Federation, 119049
Novo Nordisk Investigational Site
Novosibirsk, Russian Federation, 630008
Novo Nordisk Investigational Site
Petrozavodsk, Russian Federation, 185019
Novo Nordisk Investigational Site
Smolensk, Russian Federation, 214025
Novo Nordisk Investigational Site
St. Petersburg, Russian Federation, 190068
Novo Nordisk Investigational Site
St. Petersburg, Russian Federation, 197341
Novo Nordisk Investigational Site
Stavropol, Russian Federation, 355017
Novo Nordisk Investigational Site
Yaroslavl, Russian Federation, 150003
Spain
Novo Nordisk Investigational Site
Guadalajara, Spain, 19002
Novo Nordisk Investigational Site
Madrid, Spain, 28942
Novo Nordisk Investigational Site
Malaga, Spain, 29009
Novo Nordisk Investigational Site
Sevilla, Spain, 41014
Novo Nordisk Investigational Site
Seville, Spain, 41009
Novo Nordisk Investigational Site
Seville, Spain, 41010
Novo Nordisk Investigational Site
Valencia, Spain, 46010
Ukraine
Novo Nordisk Investigational Site
Donetsk, Ukraine, 83045
Novo Nordisk Investigational Site
Donetsk, Ukraine, 83114
Novo Nordisk Investigational Site
Ivano-Frankivsk, Ukraine, 76018
Novo Nordisk Investigational Site
Kharkiv, Ukraine, 61039
Novo Nordisk Investigational Site
Kharkiv, Ukraine, 61176
Novo Nordisk Investigational Site
Kiev, Ukraine, 1601
Novo Nordisk Investigational Site
Kyiv, Ukraine, 02232
Novo Nordisk Investigational Site
Lugansk, Ukraine, 91045
Novo Nordisk Investigational Site
Odesa, Ukraine, 65026
Novo Nordisk Investigational Site
Poltava, Ukraine, 36011
Novo Nordisk Investigational Site
Vinnytsia, Ukraine, 21018
Novo Nordisk Investigational Site
Vinnytsia, Ukraine, 21029
Novo Nordisk Investigational Site
Vinnytsya, Ukraine, 210029
Novo Nordisk Investigational Site
Vinnytsya, Ukraine, 21029
Novo Nordisk Investigational Site
Zaporizhzhia, Ukraine, 69104
Novo Nordisk Investigational Site
Zaporizhzhia, Ukraine, 69600
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01636843     History of Changes
Other Study ID Numbers: NN8226-3613
2012-000610-11 ( EudraCT Number )
U1111-1127-9324 ( Other Identifier: WHO )
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Inflammation
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors