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

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Terminated
CT.gov ID
NCT01636817
Collaborator
(none)
239
Enrollment
164
Locations
4
Arms
27
Duration (Months)
1.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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 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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
239 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 Anti-TNFa Biologics
Study Start Date :
Aug 1, 2012
Actual Primary Completion Date :
Nov 1, 2014
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

ArmIntervention/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.

Placebo Comparator: Placebo

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

Outcome Measures

Primary Outcome Measures

  1. ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) [At Week 12 (i.e., responder or non-responder)]

Secondary Outcome Measures

  1. 20%/50%/or 70% improvement of ACR score from baseline [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 [At Weeks 12 and 24]

  3. Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below) [At Weeks 12 and 24]

  4. European League Against Rheumatism (EULAR) criteria response [At Weeks 12 and 24]

  5. Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI) [At Weeks 12 and 24]

  6. Change from baseline in the overall scores of Short Form Health Survey (SF-36v2) [At Weeks 12 and 24]

  7. Incidence and type of adverse events (AEs) [At Weeks 12 and 24]

  8. Change from baseline in van der Heijde modified sharp score [At Weeks 12 and 24]

  9. ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [Week 52]

  10. Incidence and type of adverse events (AEs) [Week 52]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteHuntsvilleAlabamaUnited States35801
2Novo Nordisk Investigational SiteTuscaloosaAlabamaUnited States35406
3Novo Nordisk Investigational SiteMesaArizonaUnited States85202
4Novo Nordisk Investigational SitePhoenixArizonaUnited States85037
5Novo Nordisk Investigational SiteScottsdaleArizonaUnited States85258-4523
6Novo Nordisk Investigational SiteGlendaleCaliforniaUnited States91204
7Novo Nordisk Investigational SiteHemetCaliforniaUnited States92543
8Novo Nordisk Investigational SiteHuntington BeachCaliforniaUnited States92646
9Novo Nordisk Investigational SiteLa MesaCaliforniaUnited States91942
10Novo Nordisk Investigational SiteLakewoodCaliforniaUnited States90712
11Novo Nordisk Investigational SiteLong BeachCaliforniaUnited States90806
12Novo Nordisk Investigational SiteLong BeachCaliforniaUnited States90808-2146
13Novo Nordisk Investigational SiteLos AngelesCaliforniaUnited States90022
14Novo Nordisk Investigational SitePlacentiaCaliforniaUnited States92870
15Novo Nordisk Investigational SiteSan DiegoCaliforniaUnited States92101
16Novo Nordisk Investigational SiteSanta MonicaCaliforniaUnited States90409
17Novo Nordisk Investigational SiteUplandCaliforniaUnited States91786
18Novo Nordisk Investigational SiteBoca RatonFloridaUnited States33486
19Novo Nordisk Investigational SiteFort LauderdaleFloridaUnited States33334
20Novo Nordisk Investigational SiteGainesvilleFloridaUnited States32607
21Novo Nordisk Investigational SiteJupiterFloridaUnited States33468
22Novo Nordisk Investigational SiteNew Port RicheyFloridaUnited States34652
23Novo Nordisk Investigational SiteOcalaFloridaUnited States34474
24Novo Nordisk Investigational SiteOrlandoFloridaUnited States32804
25Novo Nordisk Investigational SiteTampaFloridaUnited States33613
26Novo Nordisk Investigational SiteVeniceFloridaUnited States34292
27Novo Nordisk Investigational SiteWest Palm BeachFloridaUnited States33407
28Novo Nordisk Investigational SiteDecaturGeorgiaUnited States30033
29Novo Nordisk Investigational SiteIdaho FallsIdahoUnited States83404
30Novo Nordisk Investigational SiteRock IslandIllinoisUnited States61201
31Novo Nordisk Investigational SiteSpringfieldIllinoisUnited States62704
32Novo Nordisk Investigational SiteSouth BendIndianaUnited States46601
33Novo Nordisk Investigational SiteCedar RapidsIowaUnited States52401-2112
34Novo Nordisk Investigational SiteKansas CityKansasUnited States66160
35Novo Nordisk Investigational SiteWichitaKansasUnited States67206
36Novo Nordisk Investigational SiteElizabethtownKentuckyUnited States42701-2988
37Novo Nordisk Investigational SiteLake CharlesLouisianaUnited States70601
38Novo Nordisk Investigational SiteShreveportLouisianaUnited States71105
39Novo Nordisk Investigational SiteBaltimoreMarylandUnited States21239
40Novo Nordisk Investigational SiteColumbiaMarylandUnited States21045
41Novo Nordisk Investigational SiteCumberlandMarylandUnited States21502
42Novo Nordisk Investigational SiteHagerstownMarylandUnited States21740
43Novo Nordisk Investigational SiteWorcesterMassachusettsUnited States01605
44Novo Nordisk Investigational SiteAnn ArborMichiganUnited States48109-0100
45Novo Nordisk Investigational SiteBattle CreekMichiganUnited States49018
46Novo Nordisk Investigational SiteFlowoodMississippiUnited States39232-9306
47Novo Nordisk Investigational SiteFlowoodMississippiUnited States39232
48Novo Nordisk Investigational SiteSaint LouisMissouriUnited States63117
49Novo Nordisk Investigational SiteSaint LouisMissouriUnited States63139-2338
50Novo Nordisk Investigational SiteSaint LouisMissouriUnited States63141-6819
51Novo Nordisk Investigational SiteLincolnNebraskaUnited States68516
52Novo Nordisk Investigational SiteCliftonNew JerseyUnited States07012
53Novo Nordisk Investigational SiteFreeholdNew JerseyUnited States07728
54Novo Nordisk Investigational SiteToms RiverNew JerseyUnited States08755
55Novo Nordisk Investigational SiteAlbuquerqueNew MexicoUnited States87102
56Novo Nordisk Investigational SiteAlbanyNew YorkUnited States12206
57Novo Nordisk Investigational SiteBrooklynNew YorkUnited States11201-4326
58Novo Nordisk Investigational SiteLake SuccessNew YorkUnited States11042
59Novo Nordisk Investigational SiteChapel HillNorth CarolinaUnited States27599
60Novo Nordisk Investigational SiteCharlotteNorth CarolinaUnited States28210
61Novo Nordisk Investigational SiteGreensboroNorth CarolinaUnited States27408
62Novo Nordisk Investigational SiteRaleighNorth CarolinaUnited States27617
63Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401-6442
64Novo Nordisk Investigational SiteCincinnatiOhioUnited States45219
65Novo Nordisk Investigational SiteColumbusOhioUnited States43203
66Novo Nordisk Investigational SiteToledoOhioUnited States43606
67Novo Nordisk Investigational SiteNormanOklahomaUnited States73069
68Novo Nordisk Investigational SiteOklahoma CityOklahomaUnited States73103
69Novo Nordisk Investigational SiteTulsaOklahomaUnited States74135
70Novo Nordisk Investigational SiteBendOregonUnited States97701
71Novo Nordisk Investigational SiteLake OswegoOregonUnited States07035
72Novo Nordisk Investigational SiteHersheyPennsylvaniaUnited States17033-2360
73Novo Nordisk Investigational SiteCharlestonSouth CarolinaUnited States29406
74Novo Nordisk Investigational SiteCharlestonSouth CarolinaUnited States29407-7757
75Novo Nordisk Investigational SiteColumbiaSouth CarolinaUnited States29204-2409
76Novo Nordisk Investigational SiteOrangeburgSouth CarolinaUnited States29118
77Novo Nordisk Investigational SiteJacksonTennesseeUnited States38305
78Novo Nordisk Investigational SiteMemphisTennesseeUnited States38104
79Novo Nordisk Investigational SiteMemphisTennesseeUnited States38119
80Novo Nordisk Investigational SiteAmarilloTexasUnited States79124
81Novo Nordisk Investigational SiteAustinTexasUnited States78721
82Novo Nordisk Investigational SiteCarrolltonTexasUnited States75007
83Novo Nordisk Investigational SiteHoustonTexasUnited States77008
84Novo Nordisk Investigational SiteHoustonTexasUnited States77034
85Novo Nordisk Investigational SiteHoustonTexasUnited States77090
86Novo Nordisk Investigational SiteMcKinneyTexasUnited States75071
87Novo Nordisk Investigational SiteSugar LandTexasUnited States77479
88Novo Nordisk Investigational SiteWacoTexasUnited States76708-3244
89Novo Nordisk Investigational SiteArlingtonVirginiaUnited States22205
90Novo Nordisk Investigational SiteSeattleWashingtonUnited States98122
91Novo Nordisk Investigational SiteTacomaWashingtonUnited States98405
92Novo Nordisk Investigational SiteBeckleyWest VirginiaUnited States25801-2805
93Novo Nordisk Investigational SiteBuenos AiresArgentinaB 1900AXI
94Novo Nordisk Investigational SiteBuenos AiresArgentinaB1878GEG
95Novo Nordisk Investigational SiteBuenos AiresArgentinaCA1199ABB
96Novo Nordisk Investigational SiteCiudad Autonoma de Buenos AireArgentina
97Novo Nordisk Investigational SiteCiudad de Buenos AiresArgentina1194
98Novo Nordisk Investigational SiteCordobaArgentinaX5002HWE
99Novo Nordisk Investigational SiteRosario CityArgentinaS2000PBJ
100Novo Nordisk Investigational SiteSan JuanArgentinaZC:5400
101Novo Nordisk Investigational SiteTucumanArgentina4000
102Novo Nordisk Investigational SiteAnderlechtBelgium1070
103Novo Nordisk Investigational SiteKortrijkBelgium8500
104Novo Nordisk Investigational SiteLiegeBelgium4000
105Novo Nordisk Investigational SiteSaint OesteGoiasBrazil74110-120
106Novo Nordisk Investigational SiteJuiz de ForaMinas GeraisBrazil36010-570
107Novo Nordisk Investigational SiteSanta Efigenia-Belo HorizonteMinas GeraisBrazil30150-221
108Novo Nordisk Investigational SiteSão PauloSao PauloBrazil01244-030
109Novo Nordisk Investigational SiteVila ClementinoSao PauloBrazil04026-000
110Novo Nordisk Investigational SiteVila ClementinoSao PauloBrazil04032-060
111Novo Nordisk Investigational SiteCuiabá - MountBrazil78040-360
112Novo Nordisk Investigational SiteCuritibaBrazil80440-080
113Novo Nordisk Investigational SiteRio Grande De SulBrazil91350-200
114Novo Nordisk Investigational SiteSao PauloBrazil04266-010
115Novo Nordisk Investigational SiteHlucinCzechia748 01
116Novo Nordisk Investigational SitePraha 2Czechia128 50
117Novo Nordisk Investigational SiteZlinCzechia76001
118Novo Nordisk Investigational SiteBois GuillaumeFrance76230
119Novo Nordisk Investigational SiteBordeauxFrance35033
120Novo Nordisk Investigational SiteEchirollesFrance38130
121Novo Nordisk Investigational SiteLyon Cedex 3France69437
122Novo Nordisk Investigational SiteNantes Cedex 01France44093
123Novo Nordisk Investigational SiteOrleansFrance45032
124Novo Nordisk Investigational SiteRennesFrance35033
125Novo Nordisk Investigational SiteBad KreuznachGermany5543
126Novo Nordisk Investigational SiteFrankfurtGermany60528
127Novo Nordisk Investigational SiteHamburgGermany22081
128Novo Nordisk Investigational SiteHerneGermany44649
129Novo Nordisk Investigational SiteKoeinGermanyD-50937
130Novo Nordisk Investigational SiteVogelsang-GommernGermany39245
131Novo Nordisk Investigational SiteDebrecenHungary4031
132Novo Nordisk Investigational SiteVeszpremHungary8200
133Novo Nordisk Investigational SiteArenzanoItaly16011
134Novo Nordisk Investigational SiteFirenzeItaly50139
135Novo Nordisk Investigational SiteGenovaItaly16132
136Novo Nordisk Investigational SiteJesiItaly60035
137Novo Nordisk Investigational SiteRomeItaly161
138Novo Nordisk Investigational SiteTorrette Di AnconaItaly60126
139Novo Nordisk Investigational SiteVeronaItaly37134
140Novo Nordisk Investigational SiteGuadalajaraJaliscoMexico44600
141Novo Nordisk Investigational SiteMexico CityMéxico, D.F.Mexico06100
142Novo Nordisk Investigational SiteMonterreyNuevo LeónMexico64000
143Novo Nordisk Investigational SiteCuliacanSinaloaMexico80230
144Novo Nordisk Investigational SiteChihuahuaMexico31000
145Novo Nordisk Investigational SiteMexico CityMexico07760
146Novo Nordisk Investigational SiteMexico CityMexicoC.P. 06700
147Novo Nordisk Investigational SiteMonterrey N.L.Mexico64000
148Novo Nordisk Investigational SiteRomaMexico06700
149Novo Nordisk Investigational SiteSan Luis PotosiMexico78200
150Novo Nordisk Investigational SiteKrakowPoland30119
151Novo Nordisk Investigational SitePoznanPoland61-218
152Novo Nordisk Investigational SiteSroda WielkopolskaPoland63-000
153Novo Nordisk Investigational SiteGuadalajaraSpain19002
154Novo Nordisk Investigational SiteMadridSpain28942
155Novo Nordisk Investigational SiteMalagaSpain29009
156Novo Nordisk Investigational SiteSevillaSpain41014
157Novo Nordisk Investigational SiteSevilleSpain41009
158Novo Nordisk Investigational SiteSevilleSpain41010
159Novo Nordisk Investigational SiteValenciaSpain46010
160Novo Nordisk Investigational SiteBarnsleyUnited KingdomS75 2EP
161Novo Nordisk Investigational SiteEastbourneUnited KingdomBN21 2UD
162Novo Nordisk Investigational SiteMaidstoneUnited KingdomME169QQ
163Novo Nordisk Investigational SiteSheffieldUnited KingdomSJO 2SJ
164Novo Nordisk Investigational SiteWolverhamptonUnited KingdomWV10 0QP

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01636817
Other Study ID Numbers:
  • NN8226-3612
  • 2012-000609-58
  • U1111-1127-9273
First Posted:
Jul 10, 2012
Last Update Posted:
Sep 5, 2018
Last Verified:
Sep 1, 2018
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2018