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

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01636843
• Collaborator: (none)
• Enrollment: 298
• Locations: 140
• Arms: 4
• Actual Duration (Months): 24.3
• Patients Per Site: 2.1
• Patients Per Site Per Month: 0.1

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 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 Design

• Study Type: Interventional
• 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: Oct 30, 2012
• Actual Primary Completion Date: Nov 10, 2014
• Actual Study Completion Date: Nov 10, 2014

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

1. ACR20, ACR50 and ACR70 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 Short Form Health Survey (SF-36v2) [At weeks 12 and 24]

6. Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI) [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. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Huntington Beach	California	United States	92646
2	Novo Nordisk Investigational Site	La Mesa	California	United States	91942
3	Novo Nordisk Investigational Site	Los Angeles	California	United States	90022
4	Novo Nordisk Investigational Site	Placentia	California	United States	92870
5	Novo Nordisk Investigational Site	Upland	California	United States	91786
6	Novo Nordisk Investigational Site	Palm Harbor	Florida	United States	34684
7	Novo Nordisk Investigational Site	Rock Island	Illinois	United States	61201
8	Novo Nordisk Investigational Site	Springfield	Illinois	United States	62704
9	Novo Nordisk Investigational Site	South Bend	Indiana	United States	46601
10	Novo Nordisk Investigational Site	Cedar Rapids	Iowa	United States	52401-2112
11	Novo Nordisk Investigational Site	Wichita	Kansas	United States	67206
12	Novo Nordisk Investigational Site	Elizabethtown	Kentucky	United States	42701-2988
13	Novo Nordisk Investigational Site	Lake Charles	Louisiana	United States	70601
14	Novo Nordisk Investigational Site	Hagerstown	Maryland	United States	21740
15	Novo Nordisk Investigational Site	Saint Louis	Missouri	United States	63117
16	Novo Nordisk Investigational Site	Kalispell	Montana	United States	59901
17	Novo Nordisk Investigational Site	Freehold	New Jersey	United States	07728
18	Novo Nordisk Investigational Site	Toms River	New Jersey	United States	08755
19	Novo Nordisk Investigational Site	Albuquerque	New Mexico	United States	87102
20	Novo Nordisk Investigational Site	Brooklyn	New York	United States	11201-4326
21	Novo Nordisk Investigational Site	Lake Success	New York	United States	11042
22	Novo Nordisk Investigational Site	Charlotte	North Carolina	United States	28210
23	Novo Nordisk Investigational Site	Norman	Oklahoma	United States	73069
24	Novo Nordisk Investigational Site	Orangeburg	South Carolina	United States	29118
25	Novo Nordisk Investigational Site	Jackson	Tennessee	United States	38305
26	Novo Nordisk Investigational Site	Memphis	Tennessee	United States	38119
27	Novo Nordisk Investigational Site	Houston	Texas	United States	77008
28	Novo Nordisk Investigational Site	Mesquite	Texas	United States	75150-5615
29	Novo Nordisk Investigational Site	Beckley	West Virginia	United States	25801-2805
30	Novo Nordisk Investigational Site	Buenos Aires		Argentina	B 1900AXI
31	Novo Nordisk Investigational Site	Buenos Aires		Argentina	B1878GEG
32	Novo Nordisk Investigational Site	Buenos Aires		Argentina	C1425DUH
33	Novo Nordisk Investigational Site	Buenos Aires		Argentina	CA1199ABB
34	Novo Nordisk Investigational Site	Ciudad Autonoma Buenos Aires		Argentina	1113
35	Novo Nordisk Investigational Site	Ciudad Autonoma de Buenos Aire		Argentina
36	Novo Nordisk Investigational Site	Ciudad de Buenos Aires		Argentina	1194
37	Novo Nordisk Investigational Site	Ciudad de Buenos Aires		Argentina	C1204AAD
38	Novo Nordisk Investigational Site	Rosario City		Argentina	S2000PBJ
39	Novo Nordisk Investigational Site	San Juan		Argentina	ZC:5400
40	Novo Nordisk Investigational Site	Tucuman		Argentina	4000
41	Novo Nordisk Investigational Site	Tucuman		Argentina	T4000BRD
42	Novo Nordisk Investigational Site	Anderlecht		Belgium	1070
43	Novo Nordisk Investigational Site	Kortrijk		Belgium	8500
44	Novo Nordisk Investigational Site	Liege		Belgium	4000
45	Novo Nordisk Investigational Site	Saint Oeste	Goias	Brazil	74110-120
46	Novo Nordisk Investigational Site	Juiz de Fora	Minas Gerais	Brazil	36010-570
47	Novo Nordisk Investigational Site	Curitiba	Parana	Brazil	80030-110
48	Novo Nordisk Investigational Site	São Paulo	Sao Paulo	Brazil	01244-030
49	Novo Nordisk Investigational Site	Vila Clementino	Sao Paulo	Brazil	04026-000
50	Novo Nordisk Investigational Site	Vila Clementino	Sao Paulo	Brazil	04032-060
51	Novo Nordisk Investigational Site	Cuiaba Mount		Brazil	78040.360
52	Novo Nordisk Investigational Site	Curitiba		Brazil	80440-080
53	Novo Nordisk Investigational Site	Rio de Janeiro		Brazil	22271-100
54	Novo Nordisk Investigational Site	Sao Paulo		Brazil	01323-903
55	Novo Nordisk Investigational Site	Sao Paulo		Brazil	04266-010
56	Novo Nordisk Investigational Site	Sao Paulo		Brazil	05437-010
57	Novo Nordisk Investigational Site	Brno		Czechia	602 00
58	Novo Nordisk Investigational Site	Brno		Czechia	625 00
59	Novo Nordisk Investigational Site	Hlucin		Czechia	748 01
60	Novo Nordisk Investigational Site	Pardubice		Czechia	530 02
61	Novo Nordisk Investigational Site	Prague 3		Czechia	130 00
62	Novo Nordisk Investigational Site	Prague 4		Czechia	14000
63	Novo Nordisk Investigational Site	Praha 11		Czechia	148 00
64	Novo Nordisk Investigational Site	Praha 2		Czechia	128 50
65	Novo Nordisk Investigational Site	Zlin		Czechia	76001
66	Novo Nordisk Investigational Site	Echirolles		France	38130
67	Novo Nordisk Investigational Site	Nantes Cedex 01		France	44093
68	Novo Nordisk Investigational Site	Orleans		France	45032
69	Novo Nordisk Investigational Site	Rennes		France	35033
70	Novo Nordisk Investigational Site	Aachen		Germany	52064
71	Novo Nordisk Investigational Site	Bad Kreuznach		Germany	5543
72	Novo Nordisk Investigational Site	Frankfurt		Germany	60528
73	Novo Nordisk Investigational Site	Hamburg		Germany	22081
74	Novo Nordisk Investigational Site	Herne		Germany	44649
75	Novo Nordisk Investigational Site	Koein		Germany	D-50937
76	Novo Nordisk Investigational Site	Vogelsang-Gommern		Germany	39245
77	Novo Nordisk Investigational Site	Kiskunhalas		Hungary	6400
78	Novo Nordisk Investigational Site	Arenzano		Italy	16011
79	Novo Nordisk Investigational Site	Firenze		Italy	50139
80	Novo Nordisk Investigational Site	Genova		Italy	16132
81	Novo Nordisk Investigational Site	Jesi		Italy	60035
82	Novo Nordisk Investigational Site	Rome		Italy	161
83	Novo Nordisk Investigational Site	Verona		Italy	37134
84	Novo Nordisk Investigational Site	Guadalajara	Jalisco	Mexico	44600
85	Novo Nordisk Investigational Site	Mexico City	México, D.F.	Mexico	06100
86	Novo Nordisk Investigational Site	Mexico	México, D.F.	Mexico	06700
87	Novo Nordisk Investigational Site	Monterrey	Nuevo León	Mexico	64000
88	Novo Nordisk Investigational Site	Culiacan	Sinaloa	Mexico	80230
89	Novo Nordisk Investigational Site	Chihuahua		Mexico	31000
90	Novo Nordisk Investigational Site	Mexico City		Mexico	03100
91	Novo Nordisk Investigational Site	Mexico City		Mexico	07760
92	Novo Nordisk Investigational Site	Mexico City		Mexico	C.P. 06700
93	Novo Nordisk Investigational Site	Monterrey N.L.		Mexico	64000
94	Novo Nordisk Investigational Site	Roma		Mexico	06700
95	Novo Nordisk Investigational Site	San Luis Potosi		Mexico	78200
96	Novo Nordisk Investigational Site	Bialystok		Poland	15-879
97	Novo Nordisk Investigational Site	Gdynia		Poland	81-384
98	Novo Nordisk Investigational Site	Katowice		Poland	40-040
99	Novo Nordisk Investigational Site	Krakow		Poland	30119
100	Novo Nordisk Investigational Site	Poznan		Poland	60-218
101	Novo Nordisk Investigational Site	Sroda Wielkopolska		Poland	63-000
102	Novo Nordisk Investigational Site	Warsaw		Poland	01-868
103	Novo Nordisk Investigational Site	Warsaw		Poland	04-141
104	Novo Nordisk Investigational Site	Wroclaw		Poland	50-381
105	Novo Nordisk Investigational Site	Barnaul		Russian Federation	656024
106	Novo Nordisk Investigational Site	Barnaul		Russian Federation	656055
107	Novo Nordisk Investigational Site	Ekaterinburg		Russian Federation	620102
108	Novo Nordisk Investigational Site	Kemerovo		Russian Federation	193257
109	Novo Nordisk Investigational Site	Moscow		Russian Federation	115522
110	Novo Nordisk Investigational Site	Moscow		Russian Federation	119049
111	Novo Nordisk Investigational Site	Novosibirsk		Russian Federation	630008
112	Novo Nordisk Investigational Site	Petrozavodsk		Russian Federation	185019
113	Novo Nordisk Investigational Site	Smolensk		Russian Federation	214025
114	Novo Nordisk Investigational Site	St. Petersburg		Russian Federation	190068
115	Novo Nordisk Investigational Site	St. Petersburg		Russian Federation	197341
116	Novo Nordisk Investigational Site	Stavropol		Russian Federation	355017
117	Novo Nordisk Investigational Site	Yaroslavl		Russian Federation	150003
118	Novo Nordisk Investigational Site	Guadalajara		Spain	19002
119	Novo Nordisk Investigational Site	Madrid		Spain	28942
120	Novo Nordisk Investigational Site	Malaga		Spain	29009
121	Novo Nordisk Investigational Site	Sevilla		Spain	41014
122	Novo Nordisk Investigational Site	Seville		Spain	41009
123	Novo Nordisk Investigational Site	Seville		Spain	41010
124	Novo Nordisk Investigational Site	Valencia		Spain	46010
125	Novo Nordisk Investigational Site	Donetsk		Ukraine	83045
126	Novo Nordisk Investigational Site	Donetsk		Ukraine	83114
127	Novo Nordisk Investigational Site	Ivano-Frankivsk		Ukraine	76018
128	Novo Nordisk Investigational Site	Kharkiv		Ukraine	61039
129	Novo Nordisk Investigational Site	Kharkiv		Ukraine	61176
130	Novo Nordisk Investigational Site	Kiev		Ukraine	1601
131	Novo Nordisk Investigational Site	Kyiv		Ukraine	02232
132	Novo Nordisk Investigational Site	Lugansk		Ukraine	91045
133	Novo Nordisk Investigational Site	Odesa		Ukraine	65026
134	Novo Nordisk Investigational Site	Poltava		Ukraine	36011
135	Novo Nordisk Investigational Site	Vinnytsia		Ukraine	21018
136	Novo Nordisk Investigational Site	Vinnytsia		Ukraine	21029
137	Novo Nordisk Investigational Site	Vinnytsya		Ukraine	210029
138	Novo Nordisk Investigational Site	Vinnytsya		Ukraine	21029
139	Novo Nordisk Investigational Site	Zaporizhzhia		Ukraine	69104
140	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01636843
• Other Study ID Numbers: NN8226-3613; 2012-000610-11; U1111-1127-9324
• First Posted: Jul 10, 2012
• Last Update Posted: Sep 5, 2018
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation

Study Results

No Results Posted as of Sep 5, 2018