A Phase IIIB Multicenter, Randomized, Double-Blind, Double-Dummy Study to Compare the Efficacy and Safety of Abatacept Administered Subcutaneously and Intravenously in Subjects With Rheumatoid Arthritis, Receiving Background Methotrexate, and Experiencing an Inadequate Response to Methotrexate

CompletadoFase 3ClinicalTrials.gov

ID: NCT00559585Tipo: INTERVENTIONALInicio: 1 de ene de 2008Fin estimado: 1 de sept de 2014

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to determine whether a weekly subcutaneous dose of abatacept yields clinical efficacy comparable to that of monthly intravenous doses of abatacept in participants with rheumatoid arthritis and an inadequate response to current methotrexate therapy.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Subjects who are considered methotrexate inadequate responders
or more swollen joints (66 joint count) and 12 or more tender joints (68 joint count)

Criterios de exclusión

Subjects who failed one or multiple anti-tumor necrosis factor (TNF) therapies
Subjects who meet diagnostic criteria for any other rheumatic disease (e.g., lupus erythematous)
Subjects with active vasculitis of a major organ system (except for subcutaneous rheumatoid nodules)
Subjects with severe chronic or recurrent bacterial infections
Subjects who have received treatment with rituximab
An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.

Intervenciones

drug

Subcutaneous (SC) Abatacept

Participants received 125 mg weekly SC abatacept injections (with an intravenous \[IV\] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.

drug

Intravenous (IV) Abatacept

Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). 500mg (for body weight up to 60 kg) 750 mg (body weight between 61 and 100 kg) 1g (body weight above 100 kg)infusions

Ubicaciones

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Buenos Aires, Buenos Aires, Argentina

Local Institution

Ciudad Autonoma, Buenos Aires, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Córdoba, Córdoba Province, Argentina

Local Institution

Rosario, Santa Fe, Santa Fe Province, Argentina

Local Institution

Santa Fe, Santa Fe Province, Argentina

Local Institution

San Miguel de Tucumán, Tucumán Province, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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