A Study on Safety and Efficacy of Tocilizumab (RoActemra/Actemra) Alone or in Combination With Non-Biologic Antirheumatics in Participants With Rheumatoid Arthritis (OSCAR)

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Non-Biologic DMARDs; Drug: Methotrexate; Drug: Tocilizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01987479

ML28702

2013-000342-19 (EudraCT Number)

Details and patient eligibility

About

This multi-center, open-label single arm Phase IIIb study will evaluate the safety and efficacy of subcutaneous (SC) tocilizumab administered as monotherapy and/or in combination with methotrexate or other non-biologic disease modifying antirheumatic drugs (DMARDs) in participants with rheumatoid arthritis (RA) with an inadequate response to non-biologic DMARDs.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
• Oral corticosteroids (≤10 mg/day prednisone or equivalent), nonsteroidal anti-inflammatory drugs (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for greater than or equal to (≥]) 4 weeks prior to Baseline.
• Use of effective contraception throughout the study as defined by protocol; female participants of childbearing potential cannot be pregnant.

Exclusion criteria

• Presence of clinically significant medical conditions.
• History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal disease that might predispose to perforation.
• Current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections.
• Any infection requiring hospitalization or treatment with intravenous antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
• Clinically significant findings on laboratory tests.
• Positive hepatitis B surface antigen or hepatitis C antibody.
• Active tuberculosis requiring treatment within the previous 3 years.
• Evidence of active malignant disease, malignancies diagnosed within the previous 10 years, or breast cancer diagnosed within the previous 20 years.
• History of alcohol, drug, or chemical abuse within 1 year prior to Screening.
• Neuropathies or other conditions that might interfere with pain evaluation.
• 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, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g., vasculitis, pulmonary fibrosis or Felty's syndrome). Secondary Sjögren's syndrome with RA is permitted.
• Functional Class IV as defined by the ACR Classification of Functional Status in RA.
• Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16 years.
• Prior history of or current inflammatory joint disease other than RA.
• Exposure to tocilizumab (either intravenous or SC) 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, including investigational agents or approved therapies, with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
• Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
• Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Tocilizumab Alone or in Combination with Methotrexate or DMARD

Experimental group

Description:

Participants will receive a weekly SC injection of tocilizumab 162 milligrams (mg) as monotherapy or in combination with methotrexate or other non-biologic DMARDs for 24 weeks.

Treatment:

Drug: Tocilizumab

Drug: Methotrexate

Drug: Non-Biologic DMARDs