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
164
4
27
1.5
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 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 Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
| 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.
|
| Placebo Comparator: Placebo
|
Drug: placebo
Administered subcutaneously (s.c., under the skin) once weekly.
|
Outcome Measures
Primary Outcome Measures
- ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) [At Week 12 (i.e., responder or non-responder)]
Secondary Outcome Measures
- 20%/50%/or 70% improvement of ACR score from baseline [At Weeks 12 and 24]
- Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline [At Weeks 12 and 24]
- Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below) [At Weeks 12 and 24]
- European League Against Rheumatism (EULAR) criteria response [At Weeks 12 and 24]
- Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI) [At Weeks 12 and 24]
- Change from baseline in the overall scores of Short Form Health Survey (SF-36v2) [At Weeks 12 and 24]
- Incidence and type of adverse events (AEs) [At Weeks 12 and 24]
- Change from baseline in van der Heijde modified sharp score [At Weeks 12 and 24]
- ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [Week 52]
- 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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novo Nordisk Investigational Site | Huntsville | Alabama | United States | 35801 |
| 2 | Novo Nordisk Investigational Site | Tuscaloosa | Alabama | United States | 35406 |
| 3 | Novo Nordisk Investigational Site | Mesa | Arizona | United States | 85202 |
| 4 | Novo Nordisk Investigational Site | Phoenix | Arizona | United States | 85037 |
| 5 | Novo Nordisk Investigational Site | Scottsdale | Arizona | United States | 85258-4523 |
| 6 | Novo Nordisk Investigational Site | Glendale | California | United States | 91204 |
| 7 | Novo Nordisk Investigational Site | Hemet | California | United States | 92543 |
| 8 | Novo Nordisk Investigational Site | Huntington Beach | California | United States | 92646 |
| 9 | Novo Nordisk Investigational Site | La Mesa | California | United States | 91942 |
| 10 | Novo Nordisk Investigational Site | Lakewood | California | United States | 90712 |
| 11 | Novo Nordisk Investigational Site | Long Beach | California | United States | 90806 |
| 12 | Novo Nordisk Investigational Site | Long Beach | California | United States | 90808-2146 |
| 13 | Novo Nordisk Investigational Site | Los Angeles | California | United States | 90022 |
| 14 | Novo Nordisk Investigational Site | Placentia | California | United States | 92870 |
| 15 | Novo Nordisk Investigational Site | San Diego | California | United States | 92101 |
| 16 | Novo Nordisk Investigational Site | Santa Monica | California | United States | 90409 |
| 17 | Novo Nordisk Investigational Site | Upland | California | United States | 91786 |
| 18 | Novo Nordisk Investigational Site | Boca Raton | Florida | United States | 33486 |
| 19 | Novo Nordisk Investigational Site | Fort Lauderdale | Florida | United States | 33334 |
| 20 | Novo Nordisk Investigational Site | Gainesville | Florida | United States | 32607 |
| 21 | Novo Nordisk Investigational Site | Jupiter | Florida | United States | 33468 |
| 22 | Novo Nordisk Investigational Site | New Port Richey | Florida | United States | 34652 |
| 23 | Novo Nordisk Investigational Site | Ocala | Florida | United States | 34474 |
| 24 | Novo Nordisk Investigational Site | Orlando | Florida | United States | 32804 |
| 25 | Novo Nordisk Investigational Site | Tampa | Florida | United States | 33613 |
| 26 | Novo Nordisk Investigational Site | Venice | Florida | United States | 34292 |
| 27 | Novo Nordisk Investigational Site | West Palm Beach | Florida | United States | 33407 |
| 28 | Novo Nordisk Investigational Site | Decatur | Georgia | United States | 30033 |
| 29 | Novo Nordisk Investigational Site | Idaho Falls | Idaho | United States | 83404 |
| 30 | Novo Nordisk Investigational Site | Rock Island | Illinois | United States | 61201 |
| 31 | Novo Nordisk Investigational Site | Springfield | Illinois | United States | 62704 |
| 32 | Novo Nordisk Investigational Site | South Bend | Indiana | United States | 46601 |
| 33 | Novo Nordisk Investigational Site | Cedar Rapids | Iowa | United States | 52401-2112 |
| 34 | Novo Nordisk Investigational Site | Kansas City | Kansas | United States | 66160 |
| 35 | Novo Nordisk Investigational Site | Wichita | Kansas | United States | 67206 |
| 36 | Novo Nordisk Investigational Site | Elizabethtown | Kentucky | United States | 42701-2988 |
| 37 | Novo Nordisk Investigational Site | Lake Charles | Louisiana | United States | 70601 |
| 38 | Novo Nordisk Investigational Site | Shreveport | Louisiana | United States | 71105 |
| 39 | Novo Nordisk Investigational Site | Baltimore | Maryland | United States | 21239 |
| 40 | Novo Nordisk Investigational Site | Columbia | Maryland | United States | 21045 |
| 41 | Novo Nordisk Investigational Site | Cumberland | Maryland | United States | 21502 |
| 42 | Novo Nordisk Investigational Site | Hagerstown | Maryland | United States | 21740 |
| 43 | Novo Nordisk Investigational Site | Worcester | Massachusetts | United States | 01605 |
| 44 | Novo Nordisk Investigational Site | Ann Arbor | Michigan | United States | 48109-0100 |
| 45 | Novo Nordisk Investigational Site | Battle Creek | Michigan | United States | 49018 |
| 46 | Novo Nordisk Investigational Site | Flowood | Mississippi | United States | 39232-9306 |
| 47 | Novo Nordisk Investigational Site | Flowood | Mississippi | United States | 39232 |
| 48 | Novo Nordisk Investigational Site | Saint Louis | Missouri | United States | 63117 |
| 49 | Novo Nordisk Investigational Site | Saint Louis | Missouri | United States | 63139-2338 |
| 50 | Novo Nordisk Investigational Site | Saint Louis | Missouri | United States | 63141-6819 |
| 51 | Novo Nordisk Investigational Site | Lincoln | Nebraska | United States | 68516 |
| 52 | Novo Nordisk Investigational Site | Clifton | New Jersey | United States | 07012 |
| 53 | Novo Nordisk Investigational Site | Freehold | New Jersey | United States | 07728 |
| 54 | Novo Nordisk Investigational Site | Toms River | New Jersey | United States | 08755 |
| 55 | Novo Nordisk Investigational Site | Albuquerque | New Mexico | United States | 87102 |
| 56 | Novo Nordisk Investigational Site | Albany | New York | United States | 12206 |
| 57 | Novo Nordisk Investigational Site | Brooklyn | New York | United States | 11201-4326 |
| 58 | Novo Nordisk Investigational Site | Lake Success | New York | United States | 11042 |
| 59 | Novo Nordisk Investigational Site | Chapel Hill | North Carolina | United States | 27599 |
| 60 | Novo Nordisk Investigational Site | Charlotte | North Carolina | United States | 28210 |
| 61 | Novo Nordisk Investigational Site | Greensboro | North Carolina | United States | 27408 |
| 62 | Novo Nordisk Investigational Site | Raleigh | North Carolina | United States | 27617 |
| 63 | Novo Nordisk Investigational Site | Wilmington | North Carolina | United States | 28401-6442 |
| 64 | Novo Nordisk Investigational Site | Cincinnati | Ohio | United States | 45219 |
| 65 | Novo Nordisk Investigational Site | Columbus | Ohio | United States | 43203 |
| 66 | Novo Nordisk Investigational Site | Toledo | Ohio | United States | 43606 |
| 67 | Novo Nordisk Investigational Site | Norman | Oklahoma | United States | 73069 |
| 68 | Novo Nordisk Investigational Site | Oklahoma City | Oklahoma | United States | 73103 |
| 69 | Novo Nordisk Investigational Site | Tulsa | Oklahoma | United States | 74135 |
| 70 | Novo Nordisk Investigational Site | Bend | Oregon | United States | 97701 |
| 71 | Novo Nordisk Investigational Site | Lake Oswego | Oregon | United States | 07035 |
| 72 | Novo Nordisk Investigational Site | Hershey | Pennsylvania | United States | 17033-2360 |
| 73 | Novo Nordisk Investigational Site | Charleston | South Carolina | United States | 29406 |
| 74 | Novo Nordisk Investigational Site | Charleston | South Carolina | United States | 29407-7757 |
| 75 | Novo Nordisk Investigational Site | Columbia | South Carolina | United States | 29204-2409 |
| 76 | Novo Nordisk Investigational Site | Orangeburg | South Carolina | United States | 29118 |
| 77 | Novo Nordisk Investigational Site | Jackson | Tennessee | United States | 38305 |
| 78 | Novo Nordisk Investigational Site | Memphis | Tennessee | United States | 38104 |
| 79 | Novo Nordisk Investigational Site | Memphis | Tennessee | United States | 38119 |
| 80 | Novo Nordisk Investigational Site | Amarillo | Texas | United States | 79124 |
| 81 | Novo Nordisk Investigational Site | Austin | Texas | United States | 78721 |
| 82 | Novo Nordisk Investigational Site | Carrollton | Texas | United States | 75007 |
| 83 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77008 |
| 84 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77034 |
| 85 | Novo Nordisk Investigational Site | Houston | Texas | United States | 77090 |
| 86 | Novo Nordisk Investigational Site | McKinney | Texas | United States | 75071 |
| 87 | Novo Nordisk Investigational Site | Sugar Land | Texas | United States | 77479 |
| 88 | Novo Nordisk Investigational Site | Waco | Texas | United States | 76708-3244 |
| 89 | Novo Nordisk Investigational Site | Arlington | Virginia | United States | 22205 |
| 90 | Novo Nordisk Investigational Site | Seattle | Washington | United States | 98122 |
| 91 | Novo Nordisk Investigational Site | Tacoma | Washington | United States | 98405 |
| 92 | Novo Nordisk Investigational Site | Beckley | West Virginia | United States | 25801-2805 |
| 93 | Novo Nordisk Investigational Site | Buenos Aires | Argentina | B 1900AXI | |
| 94 | Novo Nordisk Investigational Site | Buenos Aires | Argentina | B1878GEG | |
| 95 | Novo Nordisk Investigational Site | Buenos Aires | Argentina | CA1199ABB | |
| 96 | Novo Nordisk Investigational Site | Ciudad Autonoma de Buenos Aire | Argentina | ||
| 97 | Novo Nordisk Investigational Site | Ciudad de Buenos Aires | Argentina | 1194 | |
| 98 | Novo Nordisk Investigational Site | Cordoba | Argentina | X5002HWE | |
| 99 | Novo Nordisk Investigational Site | Rosario City | Argentina | S2000PBJ | |
| 100 | Novo Nordisk Investigational Site | San Juan | Argentina | ZC:5400 | |
| 101 | Novo Nordisk Investigational Site | Tucuman | Argentina | 4000 | |
| 102 | Novo Nordisk Investigational Site | Anderlecht | Belgium | 1070 | |
| 103 | Novo Nordisk Investigational Site | Kortrijk | Belgium | 8500 | |
| 104 | Novo Nordisk Investigational Site | Liege | Belgium | 4000 | |
| 105 | Novo Nordisk Investigational Site | Saint Oeste | Goias | Brazil | 74110-120 |
| 106 | Novo Nordisk Investigational Site | Juiz de Fora | Minas Gerais | Brazil | 36010-570 |
| 107 | Novo Nordisk Investigational Site | Santa Efigenia-Belo Horizonte | Minas Gerais | Brazil | 30150-221 |
| 108 | Novo Nordisk Investigational Site | São Paulo | Sao Paulo | Brazil | 01244-030 |
| 109 | Novo Nordisk Investigational Site | Vila Clementino | Sao Paulo | Brazil | 04026-000 |
| 110 | Novo Nordisk Investigational Site | Vila Clementino | Sao Paulo | Brazil | 04032-060 |
| 111 | Novo Nordisk Investigational Site | Cuiabá - Mount | Brazil | 78040-360 | |
| 112 | Novo Nordisk Investigational Site | Curitiba | Brazil | 80440-080 | |
| 113 | Novo Nordisk Investigational Site | Rio Grande De Sul | Brazil | 91350-200 | |
| 114 | Novo Nordisk Investigational Site | Sao Paulo | Brazil | 04266-010 | |
| 115 | Novo Nordisk Investigational Site | Hlucin | Czechia | 748 01 | |
| 116 | Novo Nordisk Investigational Site | Praha 2 | Czechia | 128 50 | |
| 117 | Novo Nordisk Investigational Site | Zlin | Czechia | 76001 | |
| 118 | Novo Nordisk Investigational Site | Bois Guillaume | France | 76230 | |
| 119 | Novo Nordisk Investigational Site | Bordeaux | France | 35033 | |
| 120 | Novo Nordisk Investigational Site | Echirolles | France | 38130 | |
| 121 | Novo Nordisk Investigational Site | Lyon Cedex 3 | France | 69437 | |
| 122 | Novo Nordisk Investigational Site | Nantes Cedex 01 | France | 44093 | |
| 123 | Novo Nordisk Investigational Site | Orleans | France | 45032 | |
| 124 | Novo Nordisk Investigational Site | Rennes | France | 35033 | |
| 125 | Novo Nordisk Investigational Site | Bad Kreuznach | Germany | 5543 | |
| 126 | Novo Nordisk Investigational Site | Frankfurt | Germany | 60528 | |
| 127 | Novo Nordisk Investigational Site | Hamburg | Germany | 22081 | |
| 128 | Novo Nordisk Investigational Site | Herne | Germany | 44649 | |
| 129 | Novo Nordisk Investigational Site | Koein | Germany | D-50937 | |
| 130 | Novo Nordisk Investigational Site | Vogelsang-Gommern | Germany | 39245 | |
| 131 | Novo Nordisk Investigational Site | Debrecen | Hungary | 4031 | |
| 132 | Novo Nordisk Investigational Site | Veszprem | Hungary | 8200 | |
| 133 | Novo Nordisk Investigational Site | Arenzano | Italy | 16011 | |
| 134 | Novo Nordisk Investigational Site | Firenze | Italy | 50139 | |
| 135 | Novo Nordisk Investigational Site | Genova | Italy | 16132 | |
| 136 | Novo Nordisk Investigational Site | Jesi | Italy | 60035 | |
| 137 | Novo Nordisk Investigational Site | Rome | Italy | 161 | |
| 138 | Novo Nordisk Investigational Site | Torrette Di Ancona | Italy | 60126 | |
| 139 | Novo Nordisk Investigational Site | Verona | Italy | 37134 | |
| 140 | Novo Nordisk Investigational Site | Guadalajara | Jalisco | Mexico | 44600 |
| 141 | Novo Nordisk Investigational Site | Mexico City | México, D.F. | Mexico | 06100 |
| 142 | Novo Nordisk Investigational Site | Monterrey | Nuevo León | Mexico | 64000 |
| 143 | Novo Nordisk Investigational Site | Culiacan | Sinaloa | Mexico | 80230 |
| 144 | Novo Nordisk Investigational Site | Chihuahua | Mexico | 31000 | |
| 145 | Novo Nordisk Investigational Site | Mexico City | Mexico | 07760 | |
| 146 | Novo Nordisk Investigational Site | Mexico City | Mexico | C.P. 06700 | |
| 147 | Novo Nordisk Investigational Site | Monterrey N.L. | Mexico | 64000 | |
| 148 | Novo Nordisk Investigational Site | Roma | Mexico | 06700 | |
| 149 | Novo Nordisk Investigational Site | San Luis Potosi | Mexico | 78200 | |
| 150 | Novo Nordisk Investigational Site | Krakow | Poland | 30119 | |
| 151 | Novo Nordisk Investigational Site | Poznan | Poland | 61-218 | |
| 152 | Novo Nordisk Investigational Site | Sroda Wielkopolska | Poland | 63-000 | |
| 153 | Novo Nordisk Investigational Site | Guadalajara | Spain | 19002 | |
| 154 | Novo Nordisk Investigational Site | Madrid | Spain | 28942 | |
| 155 | Novo Nordisk Investigational Site | Malaga | Spain | 29009 | |
| 156 | Novo Nordisk Investigational Site | Sevilla | Spain | 41014 | |
| 157 | Novo Nordisk Investigational Site | Seville | Spain | 41009 | |
| 158 | Novo Nordisk Investigational Site | Seville | Spain | 41010 | |
| 159 | Novo Nordisk Investigational Site | Valencia | Spain | 46010 | |
| 160 | Novo Nordisk Investigational Site | Barnsley | United Kingdom | S75 2EP | |
| 161 | Novo Nordisk Investigational Site | Eastbourne | United Kingdom | BN21 2UD | |
| 162 | Novo Nordisk Investigational Site | Maidstone | United Kingdom | ME169QQ | |
| 163 | Novo Nordisk Investigational Site | Sheffield | United Kingdom | SJO 2SJ | |
| 164 | Novo Nordisk Investigational Site | Wolverhampton | United Kingdom | WV10 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