A Double-Blind, Randomized, Parallel-Arm, Multicenter Study to Determine the Dose Response of Methotrexate (MTX) in Combination Therapy With Adalimumab in Subjects With Early Rheumatoid Arthritis (CONCERTO)

CompletadoFase 3ClinicalTrials.gov

ID: NCT01185301Tipo: INTERVENTIONALInicio: 1 de oct de 2010Fin estimado: 1 de sept de 2012

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine the effects of different doses of methotrexate (MTX) when taken with adalimumab in subjects with early rheumatoid arthritis (RA).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Male and female subjects at least 18 years of age
Subject has a diagnosis of Rheumatoid Arthritis (RA) as defined by either the 1987-revised American College of Rheumatology (ACR) classification criteria or the new ACR/ European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider
Subject must meet the following criteria:
Disease Activity Score of C-reactive Protein (DAS28\[CRP\]) ≥ 3.2 (at the Baseline visit only)
At least 6 swollen joints out of 66 assessed (at the Screening and Baseline visits)
At least 8 tender joints out of 68 assessed (at the Screening and Baseline visits)
C-reactive protein (CRP) ≥ 1.5 mg/dL (at the Screening visit only), or erythrocyte sedimentation rate (ESR) ≥ 28 mm/1h (at the Screening and Baseline visits)
Fulfill at least one of the following three criteria: Rheumatoid Factor (RF) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-CCP) antibody positive
Subject is judged to be in good health as determined by the Principal Investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (CXR), and a 12-lead electrocardiogram (ECG) performed during Screening

Criterios de exclusión

Subject has previous exposure to any systemic biologic therapy including adalimumab
Subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (DMARDs) or with methotrexate (MTX)
Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study)
Subject has chronic arthritis diagnosed before age 17 years
History of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active Hepatitis C infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB)
Hepatitis B virus: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the hepatitis B virus DNA (HBV DNA) polymerase chain reaction (PCR) qualitative test
Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the Baseline Visit or oral anti-infectives within 14 days prior to the Baseline visit
Female subject who is pregnant or breast-feeding or considering becoming pregnant

Intervenciones

biological

adalimumab

Pre-filled syringe every other week

drug

methotrexate

weekly oral capsule dosing

Ubicaciones

Site Reference ID/Investigator# 44924

Buenos Aires, Argentina

Site Reference ID/Investigator# 44926

Buenos Aires, Argentina

Site Reference ID/Investigator# 44925

Rosario, Santa Fe, Argentina

Site Reference ID/Investigator# 47302

San Juan, Argentina

Patrocinadores

PrincipalAbbVie (prior sponsor, Abbott)

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

A Double-Blind, Randomized, Parallel-Arm, Multicenter Stu... | EligiMed