Long-term Extension Study of Safety During Treatment With Tocilizumab (MRA) in Patients Completing Treatment in MRA Core Studies

CompletadoFase 3ClinicalTrials.gov

ID: NCT00720798Tipo: INTERVENTIONALInicio: 1 de sept de 2005Fin estimado: 1 de abr de 2013

Traducción no disponible, mostrando original

Resumen

This single-arm study evaluated the long-term efficacy and safety of tocilizumab in participants who had completed treatment in the tocilizumab core studies (NCT00106522 \[Roche protocol WA18062\], NCT00106574 \[Roche protocol WA18063\], and NCT00109408 \[Roche protocol WA17824\]) of adults with rheumatoid arthritis. Participants received tocilizumab alone or in combination with standard anti-rheumatic treatment.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Patients who have completed participation in 1 of the core studies in adult rheumatoid arthritis.

Criterios de exclusión

Treatment with any investigational agent since the last administration of study drug in the core studies.
Treatment with iv gamma globulin, plasmapheresis, or prosorba column since the last administration of study drug in the core studies.
Treatment with an anti-TNF or anti-IL1 agent, a T-cell co-stimulation modulator, or any biologic since the last administration of study drug in the core studies.
Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
Previous treatment with any cell-depleting therapies, including investigational agents.
Parenteral, intramuscular, or intra-articular corticosteroids within 6 weeks prior to baseline in this study.

Intervenciones

drug

Tocilizumab

For participants weighing \> 100 kg, the maximum dose of tocilizumab was 800 mg. Tocilizumab was supplied as a sterile solution in vials.

drug

Disease-modifying anti-rheumatic drugs

Disease-modifying anti-rheumatic drugs included methotrexate, chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide. These drugs could be used alone or in combination, except for the combination of methotrexate and leflunomide, which was not allowed.

drug

Non-steroidal anti-inflammatory drugs

Participants could be treated with non-steroidal anti-inflammatory drugs up to the maximum recommended dose throughout the study. The choice and doses of non-steroidal anti-inflammatory drugs were at the discretion of the investigator.

drug

Oral corticosteroids

Oral corticosteroids (≤ 10 mg/day) were permitted during the study.

Ubicaciones

Buenos Aires, Argentina

Rosario, Argentina

San Juan Bautista, Argentina

Patrocinadores

PrincipalHoffmann-La Roche

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