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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01636817
Other study ID # NN8226-3612
Secondary ID 2012-000609-58U1
Status Terminated
Phase Phase 2
First received
Last updated
Start date August 2012
Est. completion date November 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 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.


Recruitment information / eligibility

Status Terminated
Enrollment 239
Est. completion date November 2014
Est. primary completion date November 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. 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

Study Design


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 Ciudad Autonoma de Buenos Aire
Argentina Novo Nordisk Investigational Site Ciudad de Buenos Aires
Argentina Novo Nordisk Investigational Site Cordoba
Argentina Novo Nordisk Investigational Site Rosario City
Argentina Novo Nordisk Investigational Site San Juan
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 Cuiabá - Mount
Brazil Novo Nordisk Investigational Site Curitiba
Brazil Novo Nordisk Investigational Site Juiz de Fora Minas Gerais
Brazil Novo Nordisk Investigational Site Rio Grande De Sul
Brazil Novo Nordisk Investigational Site Saint Oeste Goias
Brazil Novo Nordisk Investigational Site Santa Efigenia-Belo Horizonte Minas Gerais
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 Hlucin
Czechia Novo Nordisk Investigational Site Praha 2
Czechia Novo Nordisk Investigational Site Zlin
France Novo Nordisk Investigational Site Bois Guillaume
France Novo Nordisk Investigational Site Bordeaux
France Novo Nordisk Investigational Site Echirolles
France Novo Nordisk Investigational Site Lyon Cedex 3
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 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 Debrecen
Hungary Novo Nordisk Investigational Site Veszprem
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 Torrette Di Ancona
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 City México, D.F.
Mexico Novo Nordisk Investigational Site Mexico City
Mexico Novo Nordisk Investigational Site Mexico City
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 Krakow
Poland Novo Nordisk Investigational Site Poznan
Poland Novo Nordisk Investigational Site Sroda Wielkopolska
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
United Kingdom Novo Nordisk Investigational Site Barnsley
United Kingdom Novo Nordisk Investigational Site Eastbourne
United Kingdom Novo Nordisk Investigational Site Maidstone
United Kingdom Novo Nordisk Investigational Site Sheffield
United Kingdom Novo Nordisk Investigational Site Wolverhampton
United States Novo Nordisk Investigational Site Albany New York
United States Novo Nordisk Investigational Site Albuquerque New Mexico
United States Novo Nordisk Investigational Site Amarillo Texas
United States Novo Nordisk Investigational Site Ann Arbor Michigan
United States Novo Nordisk Investigational Site Arlington Virginia
United States Novo Nordisk Investigational Site Austin Texas
United States Novo Nordisk Investigational Site Baltimore Maryland
United States Novo Nordisk Investigational Site Battle Creek Michigan
United States Novo Nordisk Investigational Site Beckley West Virginia
United States Novo Nordisk Investigational Site Bend Oregon
United States Novo Nordisk Investigational Site Boca Raton Florida
United States Novo Nordisk Investigational Site Brooklyn New York
United States Novo Nordisk Investigational Site Carrollton Texas
United States Novo Nordisk Investigational Site Cedar Rapids Iowa
United States Novo Nordisk Investigational Site Chapel Hill North Carolina
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Charleston South Carolina
United States Novo Nordisk Investigational Site Charlotte North Carolina
United States Novo Nordisk Investigational Site Cincinnati Ohio
United States Novo Nordisk Investigational Site Clifton New Jersey
United States Novo Nordisk Investigational Site Columbia South Carolina
United States Novo Nordisk Investigational Site Columbia Maryland
United States Novo Nordisk Investigational Site Columbus Ohio
United States Novo Nordisk Investigational Site Cumberland Maryland
United States Novo Nordisk Investigational Site Decatur Georgia
United States Novo Nordisk Investigational Site Elizabethtown Kentucky
United States Novo Nordisk Investigational Site Flowood Mississippi
United States Novo Nordisk Investigational Site Flowood Mississippi
United States Novo Nordisk Investigational Site Fort Lauderdale Florida
United States Novo Nordisk Investigational Site Freehold New Jersey
United States Novo Nordisk Investigational Site Gainesville Florida
United States Novo Nordisk Investigational Site Glendale California
United States Novo Nordisk Investigational Site Greensboro North Carolina
United States Novo Nordisk Investigational Site Hagerstown Maryland
United States Novo Nordisk Investigational Site Hemet California
United States Novo Nordisk Investigational Site Hershey Pennsylvania
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Houston Texas
United States Novo Nordisk Investigational Site Huntington Beach California
United States Novo Nordisk Investigational Site Huntsville Alabama
United States Novo Nordisk Investigational Site Idaho Falls Idaho
United States Novo Nordisk Investigational Site Jackson Tennessee
United States Novo Nordisk Investigational Site Jupiter Florida
United States Novo Nordisk Investigational Site Kansas City Kansas
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 Oswego Oregon
United States Novo Nordisk Investigational Site Lake Success New York
United States Novo Nordisk Investigational Site Lakewood California
United States Novo Nordisk Investigational Site Lincoln Nebraska
United States Novo Nordisk Investigational Site Long Beach California
United States Novo Nordisk Investigational Site Long Beach California
United States Novo Nordisk Investigational Site Los Angeles California
United States Novo Nordisk Investigational Site McKinney Texas
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Memphis Tennessee
United States Novo Nordisk Investigational Site Mesa Arizona
United States Novo Nordisk Investigational Site New Port Richey Florida
United States Novo Nordisk Investigational Site Norman Oklahoma
United States Novo Nordisk Investigational Site Ocala Florida
United States Novo Nordisk Investigational Site Oklahoma City Oklahoma
United States Novo Nordisk Investigational Site Orangeburg South Carolina
United States Novo Nordisk Investigational Site Orlando Florida
United States Novo Nordisk Investigational Site Phoenix Arizona
United States Novo Nordisk Investigational Site Placentia California
United States Novo Nordisk Investigational Site Raleigh North Carolina
United States Novo Nordisk Investigational Site Rock Island Illinois
United States Novo Nordisk Investigational Site Saint Louis Missouri
United States Novo Nordisk Investigational Site Saint Louis Missouri
United States Novo Nordisk Investigational Site Saint Louis Missouri
United States Novo Nordisk Investigational Site San Diego California
United States Novo Nordisk Investigational Site Santa Monica California
United States Novo Nordisk Investigational Site Scottsdale Arizona
United States Novo Nordisk Investigational Site Seattle Washington
United States Novo Nordisk Investigational Site Shreveport Louisiana
United States Novo Nordisk Investigational Site South Bend Indiana
United States Novo Nordisk Investigational Site Springfield Illinois
United States Novo Nordisk Investigational Site Sugar Land Texas
United States Novo Nordisk Investigational Site Tacoma Washington
United States Novo Nordisk Investigational Site Tampa Florida
United States Novo Nordisk Investigational Site Toledo Ohio
United States Novo Nordisk Investigational Site Toms River New Jersey
United States Novo Nordisk Investigational Site Tulsa Oklahoma
United States Novo Nordisk Investigational Site Tuscaloosa Alabama
United States Novo Nordisk Investigational Site Upland California
United States Novo Nordisk Investigational Site Venice Florida
United States Novo Nordisk Investigational Site Waco Texas
United States Novo Nordisk Investigational Site West Palm Beach Florida
United States Novo Nordisk Investigational Site Wichita Kansas
United States Novo Nordisk Investigational Site Wilmington North Carolina
United States Novo Nordisk Investigational Site Worcester Massachusetts

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,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary ACR20 (defined as 20% improvement in American College of Rheumatology criteria measures) At Week 12 (i.e., responder or non-responder)
Secondary 20%/50%/or 70% 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 Health Assessment Questionnaire - Disability Index (HAQ-DI) 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 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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