An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Non-steroidal anti-inflammatory drugs; Drug: Oral corticosteroids; Drug: Tocilizumab; Drug: Disease-modifying anti-rheumatic drugs

Study type: Interventional

Funder types: Industry

Identifiers

NCT00720798

WA18696

Details and patient eligibility

About

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.

Enrollment: 2,067 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,067 participants in 1 patient group

Tocilizumab

Experimental group

Description:

Participants received tocilizumab 8 mg/kg intravenously every 4 weeks till the end of the study (up to 7 years, 7 months). In addition, participants may have also received disease-modifying anti-rheumatic drugs, non-steroidal anti-inflammatory drugs, and oral corticosteroids at the discretion of the investigator.

Treatment:

Drug: Oral corticosteroids

Drug: Non-steroidal anti-inflammatory drugs

Drug: Disease-modifying anti-rheumatic drugs

Drug: Tocilizumab