Clinical trial NCT01636817: A Trial of NNC0109-0012, an Anti-IL-20 Biologic, in Patients With Active Rheumatoid Arthritis Who Are Inadequate Responders to Anti-TNFa Biologics
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 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: 239
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 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.


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. 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

Primary outcomes:
measure: ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures)
timeFrame: At Week 12 (i.e., responder or non-responder)
Secondary outcomes:
measure: 20%/50%/or 70% 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 Health Assessment Questionnaire - Disability Index (HAQ-DI)
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: 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: Huntsville
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Tuscaloosa
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Mesa
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Phoenix
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Scottsdale
country: United States
facility: Novo Nordisk Investigational Site
state: Arizona
city: Glendale
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Hemet
country: United States
facility: Novo Nordisk Investigational Site
state: California
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: Lakewood
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Long Beach
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: San Diego
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Santa Monica
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Upland
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Boca Raton
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Jupiter
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Ocala
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Orlando
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Tampa
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Venice
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Novo Nordisk Investigational Site
state: Florida
city: Decatur
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Idaho Falls
country: United States
facility: Novo Nordisk Investigational Site
state: Idaho
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: Kansas City
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
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: Shreveport
country: United States
facility: Novo Nordisk Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Columbia
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Cumberland
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Hagerstown
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Worcester
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Battle Creek
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Flowood
country: United States
facility: Novo Nordisk Investigational Site
state: Mississippi
city: Flowood
country: United States
facility: Novo Nordisk Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Saint Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Lincoln
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Clifton
country: United States
facility: Novo Nordisk Investigational Site
state: New Jersey
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: Albany
country: United States
facility: Novo Nordisk Investigational Site
state: New York
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: Chapel Hill
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Charlotte
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Greensboro
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Raleigh
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Novo Nordisk Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Columbus
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Toledo
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Norman
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Tulsa
country: United States
facility: Novo Nordisk Investigational Site
state: Oklahoma
city: Bend
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Lake Oswego
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Hershey
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Novo Nordisk Investigational Site
state: South Carolina
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: Memphis
country: United States
facility: Novo Nordisk Investigational Site
state: Tennessee
city: Amarillo
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Austin
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Carrollton
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: McKinney
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Sugar Land
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Waco
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Arlington
country: United States
facility: Novo Nordisk Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
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: 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: Cordoba
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: 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: Santa Efigenia-Belo Horizonte
country: Brazil
facility: Novo Nordisk Investigational Site
state: Minas Gerais
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: Cuiabá - Mount
country: Brazil
facility: Novo Nordisk Investigational Site
city: Curitiba
country: Brazil
facility: Novo Nordisk Investigational Site
city: Rio Grande De Sul
country: Brazil
facility: Novo Nordisk Investigational Site
city: Sao Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
city: Hlucin
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: Bois Guillaume
country: France
facility: Novo Nordisk Investigational Site
city: Bordeaux
country: France
facility: Novo Nordisk Investigational Site
city: Echirolles
country: France
facility: Novo Nordisk Investigational Site
city: Lyon Cedex 3
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: 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: Debrecen
country: Hungary
facility: Novo Nordisk Investigational Site
city: Veszprem
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: Torrette Di Ancona
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: 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: 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: 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: 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: Barnsley
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Eastbourne
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Maidstone
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Wolverhampton
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: