A Study of the Efficacy and Safety of Tocilizumab in Adults With Rheumatoid Arthritis.

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Biological: tocilizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01988012

ML28698

Details and patient eligibility

About

A multi-center, open-label single-arm study to evaluate the efficacy and safety of tocilizumab administered as a single, weekly injection in adults with rheumatoid arthritis. Combination therapy with methotrexate or other non-biologic disease modifying anti-rheumatic drugs (DMARDs) was permitted.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adults >/= 18 years of age
Diagnosis of active rheumatoid arthritis (RA) according to the revised (1987) American College of Rheumatology (ACR) criteria or European League Against Rheumatism (EULAR)/ACR (2010) criteria
Previously treated with the following: three non-biologic DMARDs, and not treated with any biologic agent OR one biologic agent (alone or in combination with non-biologic DMARDs), and discontinued that agent for a reason
Oral corticosteroids (</= 10 mg/day prednisone or equivalent), non-steroidal anti-inflammatory drug (NSAIDs) and non-biologic DMARDs are permitted if on a stable dose regimen for >/= 4 weeks prior to Baseline
Use of effective contraception throughout the study as defined by protocol; female patients of childbearing potential must not be pregnant

Exclusion criteria

Presence of serious, uncontrolled, clinically significant medical conditions
History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower gastrointestinal (GI) 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 (IV) antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening
Clinically significant findings on lab tests and/or hepatitis B or C, or human immunodeficiency virus (HIV) screenings
Active tuberculosis (TB) requiring treatments 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 erythematosus, 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-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 (either IV or subcutaneous administration) 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 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