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
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

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

External Links

•   Clinical Trials at Novo Nordisk