A Randomised, Double Blind, Placebo-controlled, Multiple ... | EligiMed

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

TerminadoFase 2ClinicalTrials.gov

ID: NCT01636817Tipo: INTERVENTIONALInicio: 1 de ago de 2012Fin estimado: 1 de nov de 2014

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

NNC0109-0012

Administered subcutaneously (s.c., under the skin) once weekly.

drug

placebo

Administered subcutaneously (s.c., under the skin) once weekly.

Ubicaciones

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

Córdoba, Argentina

Novo Nordisk Investigational Site

Rosario, Argentina

Novo Nordisk Investigational Site

San Juan, Argentina

Novo Nordisk Investigational Site

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalNovo Nordisk A/S

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