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

NCT ID: NCT01988012

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab

Adults with rheumatoid arthritis will be treated with tocilizumab for 24 weeks followed by an 8 week follow-up period without treatment.

Group Type: EXPERIMENTAL

tocilizumab

Intervention Type: BIOLOGICAL

162 milligram (mg) administered subcutaneously once weekly for 24 weeks

Interventions

tocilizumab

162 milligram (mg) administered subcutaneously once weekly for 24 weeks

Intervention Type: BIOLOGICAL

Other Intervention Names

RoActemra/Actemra

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Beer Yaacov, , Israel

Beersheba, , Israel

Haifa, , Israel

Haifa, , Israel

Haifa, , Israel

Jerusalem, , Israel

Jerusalem, , Israel

Kfar Saba, , Israel

Petah Tikva, , Israel

Petah Tikva, , Israel

Ramat Gan, , Israel

Ramat Gan, , Israel

Tel Aviv, , Israel

Countries

Israel

References

Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Devenport J, Petho-Schramm A. Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis. Rheumatology (Oxford). 2019 Jun 1;58(6):1056-1064. doi: 10.1093/rheumatology/key393.

Reference Type: DERIVED

PMID: 30649524 (View on PubMed)

Choy E, Caporali R, Xavier R, Fautrel B, Sanmarti R, Bao M, Bernasconi C, Petho-Schramm A. Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries. Rheumatology (Oxford). 2018 Mar 1;57(3):499-507. doi: 10.1093/rheumatology/kex443.

Reference Type: DERIVED

PMID: 29244149 (View on PubMed)

Other Identifiers

ML28698

Identifier Type: -

Identifier Source: org_study_id