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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

Primary Purpose

Inflammation, Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
NNC0109-0012
placebo
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
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

Sites / Locations

  • Novo Nordisk Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

60 mg

120 mg

240 mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)

Secondary Outcome Measures

ACR20, ACR50 and ACR70 improvement of ACR score from baseline
Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
European League Against Rheumatism (EULAR) criteria response
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)
Incidence and type of adverse events (AEs)
Change from baseline in van der Heijde modified Sharp score
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Incidence and type of adverse events (AEs)

Full Information

First Posted
July 6, 2012
Last Updated
September 3, 2018
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01636843
Brief Title
A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Terminated
Study Start Date
October 30, 2012 (Actual)
Primary Completion Date
November 10, 2014 (Actual)
Study Completion Date
November 10, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
298 (Actual)

8. Arms, Groups, and Interventions

Arm Title
60 mg
Arm Type
Experimental
Arm Title
120 mg
Arm Type
Experimental
Arm Title
240 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
NNC0109-0012
Intervention Description
Administered subcutaneously (s.c., under the skin), once weekly.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Administered subcutaneously (s.c., under the skin), once weekly.
Primary Outcome Measure Information:
Title
ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
Time Frame
At week 12 (responder or non-responder)
Secondary Outcome Measure Information:
Title
ACR20, ACR50 and ACR70 improvement of ACR score from baseline
Time Frame
At weeks 12 and 24
Title
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
Title
Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
Time Frame
At weeks 12 and 24
Title
European League Against Rheumatism (EULAR) criteria response
Time Frame
At weeks 12 and 24
Title
Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)
Time Frame
At weeks 12 and 24
Title
Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time Frame
At weeks 12 and 24
Title
Incidence and type of adverse events (AEs)
Time Frame
At weeks 12 and 24
Title
Change from baseline in van der Heijde modified Sharp score
Time Frame
At weeks 12 and 24
Title
ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
Time Frame
Week 52
Title
Incidence and type of adverse events (AEs)
Time Frame
Week 52

10. Eligibility

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

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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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