An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01951170

ML28703

Details and patient eligibility

About

This open-label, single-arm study will evaluate the efficacy and safety of tocilizumab in patients with active moderate to severe rheumatoid arthritis. Participants will receive a subcutaneous dose of tocilizumab 162 mg once weekly. The anticipated time on study treatment is 24 weeks.

Enrollment

52 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients at least 18 years of age
Patients with a diagnosis of active moderate to severe rheumatoid arthritis (RA)
Oral corticosteroids and nonsteroidal anti-inflammatory are permitted if on a stable dose regimen for >/= 4 weeks prior baseline
Permitted non-biologic disease-modifying anti-rheumatic drugs (DMARDs) used alone or in combination are allowed if at a stable dose for at least 4 weeks prior to baseline
Receiving treatment on an outpatient basis, not including tocilizumab
Females of childbearing potential and males with female partners of childbearing potential may participate in this study only if using a reliable means of contraception for at least 5 months following the last dose tocilizumab
Previous or current treatment with methotrexate with an inadequate response to methotrexate, intolerance to methotrexate or treatment with methotrexate was considered as inappropriate
Evidence of one or more erosions in hands or feet assessed by X-ray attributable to RA or magnetic resonance imaging (MRI) of wrist of metacarpophalangeal (MCP) joints of dominant hand

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 rheumatoid arthritis
Functional Class IV as defined by the American College of Rheumatology (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 current inflammatory joint disease other than RA
Exposure to tocilizumab at any time prior to baseline
Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of screening
Previous treatment with any cell-depleting therapies
Treatment with intravenous (IV) gamma globulin, plasmapheresis within 6 months of baseline
Intraarticular (IA) or parenteral corticosteroids within 4 weeks prior to baseline
Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation
Treatment with 2 or more anti-tumor necrosis factor (TNF) agents or any other biologic agent at any time prior to screening
Evidence of serious uncontrolled concomitant disease (e.g., cardiovascular, nervous system, pulmonary)
History of diverticulitis, diverticulosis requiring antibiotic treatment, or chromic ulcerative lower gastrointestinal (GI) disease such as Crohn's disease, ulcerative colitis, or other symptomatic lower genitourinary (GU) conditions that might predispose to perforation
Known active current or history of recurrent infections