A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT02011334

ML28700

Details and patient eligibility

About

This multi-center, open-label, single-arm, Phase IIIb study will evaluate the safety and efficacy of subcutaneous RoActemra/Actemra alone or in combination with non-biologic disease modifying antirheumatic drugs (DMARDs) in rheumatoid arthritis patients in Latin America with an inadequate response to non-biologic DMARDs.

Enrollment

285 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients >/= 18 years of age.
Patients with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria.
Patients with moderate to severe RA (DAS-ESR 28 >/= 3.2).
Receiving non-study treatment on an outpatient basis.
Oral corticosteroids (</= 10 mg/day prednisone or equivalent), NSAIDs and non-biologic DMARDs are permitted if on a stable dose regimen for >/= 4 weeks prior to Baseline.
Inadequate response to previous non-biologic DMARD therapy.
Use of effective contraception throughout the study as defined by protocol; female patients 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 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 IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening.
Clinically significant findings on lab tests and/or hepatits B or C, or HIV screenings.
Active TB 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-Rheumatoid Arthritis (Appendix 2).
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.
Previous exposure to RoActemra/Actemra (either IV or SC).
Prior treatment with a biologic agent.
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.