Clinical trial NCT01636843: A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Methotrexate
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Inflammation
Rheumatoid Arthritis
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-07-10
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
timeFrame: At week 12 (responder or non-responder)
Secondary outcomes:
measure: ACR20, ACR50 and ACR70 improvement of ACR score from baseline
timeFrame: At weeks 12 and 24
measure: Change in DAS28-CRP (defined as Disease Activity Score for 28 joints with C-reactive protein measure) from baseline
timeFrame: At weeks 12 and 24
measure: Simplified Disease Activity Index (SDAI) remission (SDAI of 3.3 or below)
timeFrame: At weeks 12 and 24
measure: European League Against Rheumatism (EULAR) criteria response
timeFrame: At weeks 12 and 24
measure: Change from baseline in the overall scores of Short Form Health Survey (SF-36v2)
timeFrame: At weeks 12 and 24
measure: Change from baseline in the overall scores of Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: At weeks 12 and 24
measure: Incidence and type of adverse events (AEs)
timeFrame: At weeks 12 and 24
measure: Change from baseline in van der Heijde modified Sharp score
timeFrame: At weeks 12 and 24
measure: ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline)
timeFrame: Week 52
measure: Incidence and type of adverse events (AEs)
timeFrame: Week 52
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: La Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Placentia
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Upland
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Palm Harbor
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Rock Island
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: Springfield
country: United States
facility: Novo Nordisk Investigational Site
state: Illinois
city: South Bend
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Cedar Rapids
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Wichita
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Elizabethtown
country: United States
facility: Novo Nordisk Investigational Site
state: Kentucky
city: Lake Charles
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Hagerstown
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Saint Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Kalispell
country: United States
facility: Novo Nordisk Investigational Site
state: Montana
city: Freehold
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Toms River
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Novo Nordisk Investigational Site
state: New Mexico
city: Brooklyn
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Lake Success
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Norman
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Orangeburg
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Jackson
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Mesquite
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Beckley
country: United States
facility: Novo Nordisk Investigational Site
state: West Virginia
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Novo Nordisk Investigational Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Novo Nordisk Investigational Site
city: Rosario City
country: Argentina
facility: Novo Nordisk Investigational Site
city: San Juan
country: Argentina
facility: Novo Nordisk Investigational Site
city: Tucuman
country: Argentina
facility: Novo Nordisk Investigational Site
city: Tucuman
country: Argentina
facility: Novo Nordisk Investigational Site
city: Anderlecht
country: Belgium
facility: Novo Nordisk Investigational Site
city: Kortrijk
country: Belgium
facility: Novo Nordisk Investigational Site
city: Liege
country: Belgium
facility: Novo Nordisk Investigational Site
city: Saint Oeste
country: Brazil
facility: Novo Nordisk Investigational Site
state: Goias
city: Juiz de Fora
country: Brazil
facility: Novo Nordisk Investigational Site
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Novo Nordisk Investigational Site
state: Parana
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Vila Clementino
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Vila Clementino
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Cuiaba Mount
country: Brazil
facility: Novo Nordisk Investigational Site
city: Curitiba
country: Brazil
facility: Novo Nordisk Investigational Site
city: Rio de Janeiro
country: Brazil
facility: Novo Nordisk Investigational Site
city: Sao Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: Sao Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: Sao Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: Brno
country: Czechia
facility: Novo Nordisk Investigational Site
city: Brno
country: Czechia
facility: Novo Nordisk Investigational Site
city: Hlucin
country: Czechia
facility: Novo Nordisk Investigational Site
city: Pardubice
country: Czechia
facility: Novo Nordisk Investigational Site
city: Prague 3
country: Czechia
facility: Novo Nordisk Investigational Site
city: Prague 4
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 11
country: Czechia
facility: Novo Nordisk Investigational Site
city: Praha 2
country: Czechia
facility: Novo Nordisk Investigational Site
city: Zlin
country: Czechia
facility: Novo Nordisk Investigational Site
city: Echirolles
country: France
facility: Novo Nordisk Investigational Site
city: Nantes Cedex 01
country: France
facility: Novo Nordisk Investigational Site
city: Orleans
country: France
facility: Novo Nordisk Investigational Site
city: Rennes
country: France
facility: Novo Nordisk Investigational Site
city: Aachen
country: Germany
facility: Novo Nordisk Investigational Site
city: Bad Kreuznach
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Hamburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Herne
country: Germany
facility: Novo Nordisk Investigational Site
city: Koein
country: Germany
facility: Novo Nordisk Investigational Site
city: Vogelsang-Gommern
country: Germany
facility: Novo Nordisk Investigational Site
city: Kiskunhalas
country: Hungary
facility: Novo Nordisk Investigational Site
city: Arenzano
country: Italy
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Genova
country: Italy
facility: Novo Nordisk Investigational Site
city: Jesi
country: Italy
facility: Novo Nordisk Investigational Site
city: Rome
country: Italy
facility: Novo Nordisk Investigational Site
city: Verona
country: Italy
facility: Novo Nordisk Investigational Site
city: Guadalajara
country: Mexico
facility: Novo Nordisk Investigational Site
state: Jalisco
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Mexico
country: Mexico
facility: Novo Nordisk Investigational Site
state: México, D.F.
city: Monterrey
country: Mexico
facility: Novo Nordisk Investigational Site
state: Nuevo León
city: Culiacan
country: Mexico
facility: Novo Nordisk Investigational Site
state: Sinaloa
city: Chihuahua
country: Mexico
facility: Novo Nordisk Investigational Site
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
city: Mexico City
country: Mexico
facility: Novo Nordisk Investigational Site
city: Monterrey N.L.
country: Mexico
facility: Novo Nordisk Investigational Site
city: Roma
country: Mexico
facility: Novo Nordisk Investigational Site
city: San Luis Potosi
country: Mexico
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdynia
country: Poland
facility: Novo Nordisk Investigational Site
city: Katowice
country: Poland
facility: Novo Nordisk Investigational Site
city: Krakow
country: Poland
facility: Novo Nordisk Investigational Site
city: Poznan
country: Poland
facility: Novo Nordisk Investigational Site
city: Sroda Wielkopolska
country: Poland
facility: Novo Nordisk Investigational Site
city: Warsaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Warsaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Barnaul
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Barnaul
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Kemerovo
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Petrozavodsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Smolensk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Stavropol
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Guadalajara
country: Spain
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Malaga
country: Spain
facility: Novo Nordisk Investigational Site
city: Sevilla
country: Spain
facility: Novo Nordisk Investigational Site
city: Seville
country: Spain
facility: Novo Nordisk Investigational Site
city: Seville
country: Spain
facility: Novo Nordisk Investigational Site
city: Valencia
country: Spain
facility: Novo Nordisk Investigational Site
city: Donetsk
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Donetsk
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Ivano-Frankivsk
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kharkiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kharkiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kiev
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Lugansk
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Odesa
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Poltava
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Vinnytsia
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Vinnytsia
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Vinnytsya
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Vinnytsya
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Zaporizhzhia
country: Ukraine
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: