A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)

• Status: Completed
• Trial end date: 2016-09-13
• Target enrollment: 0
• Participant gender: All

Summary

This Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Antirheumatic Agents; Methotrexate

Criteria

Inclusion Criteria:

• Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria

• Moderate to severe RA with a DAS28-ESR score >3.2 points

• Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate

• Oral corticosteroids (less than or equal to [equivalent) and nonsteroidal anti-inflammatory drugs (NSAIDs) permitted if on stable dose regimen for greater than or equal to [>/=] 4 weeks prior to baseline

• Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline

• Receiving treatment on an outpatient basis, not including tocilizumab

• Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline

• Rheumatic autoimmune disease other than RA

• Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis

• Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16

• Prior history of or current inflammatory joint disease other than RA

• Exposure to tocilizumab or any other biologic DMARDs at any time prior to baseline

• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening

• Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline

• History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies

• Evidence of serious concomitant disease or disorder

• Known active current or history of recurrent infection

• Any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening

• Active tuberculosis requiring treatment within the previous 3 years

• Positive for hepatitis B or hepatitis C

• History of or current active primary or secondary immunodeficiency

• Pregnant or lactating women

• Neuropathies or other conditions that might interfere with pain evaluation

• Inadequate hematologic, renal, or liver function