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NCT01636843 Clinical Trial

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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01636843
Other study ID # NN8226-3613
Secondary ID 2012-000610-11U1
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 30, 2012
Est. completion date November 10, 2014

Study information
Verified date September 2018
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 298
Est. completion date November 10, 2014
Est. primary completion date November 10, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• NNC0109-0012
Administered subcutaneously (s.c., under the skin), once weekly.
• placebo
Administered subcutaneously (s.c., under the skin), once weekly.

Locations
Country Name City State
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Buenos Aires
Argentina Novo Nordisk Investigational Site Ciudad Autonoma Buenos Aires
Argentina Novo Nordisk Investigational Site Ciudad Autonoma de Buenos Aire
Argentina Novo Nordisk Investigational Site Ciudad de Buenos Aires
Argentina Novo Nordisk Investigational Site Ciudad de Buenos Aires
Argentina Novo Nordisk Investigational Site Rosario City
Argentina Novo Nordisk Investigational Site San Juan
Argentina Novo Nordisk Investigational Site Tucuman
Argentina Novo Nordisk Investigational Site Tucuman
Belgium Novo Nordisk Investigational Site Anderlecht
Belgium Novo Nordisk Investigational Site Kortrijk
Belgium Novo Nordisk Investigational Site Liege
Brazil Novo Nordisk Investigational Site Cuiaba Mount
Brazil Novo Nordisk Investigational Site Curitiba
Brazil Novo Nordisk Investigational Site Curitiba Parana
Brazil Novo Nordisk Investigational Site Juiz de Fora Minas Gerais
Brazil Novo Nordisk Investigational Site Rio de Janeiro
Brazil Novo Nordisk Investigational Site Saint Oeste Goias
Brazil Novo Nordisk Investigational Site Sao Paulo
Brazil Novo Nordisk Investigational Site Sao Paulo
Brazil Novo Nordisk Investigational Site Sao Paulo
Brazil Novo Nordisk Investigational Site São Paulo Sao Paulo
Brazil Novo Nordisk Investigational Site Vila Clementino Sao Paulo
Brazil Novo Nordisk Investigational Site Vila Clementino Sao Paulo
Czechia Novo Nordisk Investigational Site Brno
Czechia Novo Nordisk Investigational Site Brno
Czechia Novo Nordisk Investigational Site Hlucin
Czechia Novo Nordisk Investigational Site Pardubice
Czechia Novo Nordisk Investigational Site Prague 3
Czechia Novo Nordisk Investigational Site Prague 4
Czechia Novo Nordisk Investigational Site Praha 11
Czechia Novo Nordisk Investigational Site Praha 2
Czechia Novo Nordisk Investigational Site Zlin
France Novo Nordisk Investigational Site Echirolles
France Novo Nordisk Investigational Site Nantes Cedex 01
France Novo Nordisk Investigational Site Orleans
France Novo Nordisk Investigational Site Rennes
Germany Novo Nordisk Investigational Site Aachen
Germany Novo Nordisk Investigational Site Bad Kreuznach
Germany Novo Nordisk Investigational Site Frankfurt
Germany Novo Nordisk Investigational Site Hamburg
Germany Novo Nordisk Investigational Site Herne
Germany Novo Nordisk Investigational Site Koein
Germany Novo Nordisk Investigational Site Vogelsang-Gommern
Hungary Novo Nordisk Investigational Site Kiskunhalas
Italy Novo Nordisk Investigational Site Arenzano
Italy Novo Nordisk Investigational Site Firenze
Italy Novo Nordisk Investigational Site Genova
Italy Novo Nordisk Investigational Site Jesi
Italy Novo Nordisk Investigational Site Rome
Italy Novo Nordisk Investigational Site Verona
Mexico Novo Nordisk Investigational Site Chihuahua
Mexico Novo Nordisk Investigational Site Culiacan Sinaloa
Mexico Novo Nordisk Investigational Site Guadalajara Jalisco
Mexico Novo Nordisk Investigational Site Mexico México, D.F.
Mexico Novo Nordisk Investigational Site Mexico City
Mexico Novo Nordisk Investigational Site Mexico City
Mexico Novo Nordisk Investigational Site Mexico City
Mexico Novo Nordisk Investigational Site Mexico City México, D.F.
Mexico Novo Nordisk Investigational Site Monterrey Nuevo León
Mexico Novo Nordisk Investigational Site Monterrey N.L.
Mexico Novo Nordisk Investigational Site Roma
Mexico Novo Nordisk Investigational Site San Luis Potosi
Poland Novo Nordisk Investigational Site Bialystok
Poland Novo Nordisk Investigational Site Gdynia
Poland Novo Nordisk Investigational Site Katowice
Poland Novo Nordisk Investigational Site Krakow
Poland Novo Nordisk Investigational Site Poznan
Poland Novo Nordisk Investigational Site Sroda Wielkopolska
Poland Novo Nordisk Investigational Site Warsaw
Poland Novo Nordisk Investigational Site Warsaw
Poland Novo Nordisk Investigational Site Wroclaw
Russian Federation Novo Nordisk Investigational Site Barnaul
Russian Federation Novo Nordisk Investigational Site Barnaul
Russian Federation Novo Nordisk Investigational Site Ekaterinburg
Russian Federation Novo Nordisk Investigational Site Kemerovo
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Moscow
Russian Federation Novo Nordisk Investigational Site Novosibirsk
Russian Federation Novo Nordisk Investigational Site Petrozavodsk
Russian Federation Novo Nordisk Investigational Site Smolensk
Russian Federation Novo Nordisk Investigational Site St. Petersburg
Russian Federation Novo Nordisk Investigational Site St. Petersburg
Russian Federation Novo Nordisk Investigational Site Stavropol
Russian Federation Novo Nordisk Investigational Site Yaroslavl
Spain Novo Nordisk Investigational Site Guadalajara
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Malaga
Spain Novo Nordisk Investigational Site Sevilla
Spain Novo Nordisk Investigational Site Seville
Spain Novo Nordisk Investigational Site Seville
Spain Novo Nordisk Investigational Site Valencia
Ukraine Novo Nordisk Investigational Site Donetsk
Ukraine Novo Nordisk Investigational Site Donetsk
Ukraine Novo Nordisk Investigational Site Ivano-Frankivsk
Ukraine Novo Nordisk Investigational Site Kharkiv
Ukraine Novo Nordisk Investigational Site Kharkiv
Ukraine Novo Nordisk Investigational Site Kiev
Ukraine Novo Nordisk Investigational Site Kyiv
Ukraine Novo Nordisk Investigational Site Lugansk
Ukraine Novo Nordisk Investigational Site Odesa
Ukraine Novo Nordisk Investigational Site Poltava
Ukraine Novo Nordisk Investigational Site Vinnytsia
Ukraine Novo Nordisk Investigational Site Vinnytsia
Ukraine Novo Nordisk Investigational Site Vinnytsya
Ukraine Novo Nordisk Investigational Site Vinnytsya
Ukraine Novo Nordisk Investigational Site Zaporizhzhia
Ukraine Novo Nordisk Investigational Site Zaporizhzhia
United States Novo Nordisk Investigational Site Albuquerque New Mexico
United States Novo Nordisk Investigational Site Beckley West Virginia
United States Novo Nordisk Investigational Site Brooklyn New York
United States Novo Nordisk Investigational Site Cedar Rapids Iowa
United States Novo Nordisk Investigational Site Charlotte North Carolina
United States Novo Nordisk Investigational Site Elizabethtown Kentucky
United States Novo Nordisk Investigational Site Freehold New Jersey
United States Novo Nordisk Investigational Site Hagerstown Maryland
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Huntington Beach California
United States Novo Nordisk Investigational Site Jackson Tennessee
United States Novo Nordisk Investigational Site Kalispell Montana
United States Novo Nordisk Investigational Site La Mesa California
United States Novo Nordisk Investigational Site Lake Charles Louisiana
United States Novo Nordisk Investigational Site Lake Success New York
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Mesquite Texas
United States Novo Nordisk Investigational Site Norman Oklahoma
United States Novo Nordisk Investigational Site Orangeburg South Carolina
United States Novo Nordisk Investigational Site Palm Harbor Florida
United States Novo Nordisk Investigational Site Placentia California
United States Novo Nordisk Investigational Site Rock Island Illinois
United States Novo Nordisk Investigational Site Saint Louis Missouri
United States Novo Nordisk Investigational Site South Bend Indiana
United States Novo Nordisk Investigational Site Springfield Illinois
United States Novo Nordisk Investigational Site Toms River New Jersey
United States Novo Nordisk Investigational Site Upland California
United States Novo Nordisk Investigational Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Czechia,  France,  Germany,  Hungary,  Italy,  Mexico,  Poland,  Russian Federation,  Spain,  Ukraine, 

Outcome
Type Measure Description Time frame Safety issue
Primary ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) At week 12 (responder or non-responder)
Secondary ACR20, ACR50 and ACR70 improvement of ACR score from baseline At weeks 12 and 24
Secondary Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline At weeks 12 and 24
Secondary Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below) At weeks 12 and 24
Secondary European League Against Rheumatism (EULAR) criteria response At weeks 12 and 24
Secondary Change from baseline in the overall scores of Short Form Health Survey (SF-36v2) At weeks 12 and 24
Secondary Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI) At weeks 12 and 24
Secondary Incidence and type of adverse events (AEs) At weeks 12 and 24
Secondary Change from baseline in van der Heijde modified Sharp score At weeks 12 and 24
Secondary ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) Week 52
Secondary Incidence and type of adverse events (AEs) Week 52
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