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

NCT ID: NCT01951170

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-08-31

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Study Design

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

Study Groups

Tocilizumab

Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.

Group Type: EXPERIMENTAL

Tocilizumab

Intervention Type: DRUG

162 milligrams (mg) tocilizumab was administered subcutaneously once weekly for 24 weeks

Interventions

Tocilizumab

162 milligrams (mg) tocilizumab was administered subcutaneously once weekly for 24 weeks

Intervention Type: DRUG

Other Intervention Names

RoActemra®/Actemra®

Eligibility Criteria

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

• 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

Camperdown, New South Wales, Australia

Coffs Harbour, New South Wales, Australia

Kogarah, New South Wales, Australia

Southport, Queensland, Australia

Adelaide, South Australia, Australia

Hobart, Tasmania, Australia

Geelong, Victoria, Australia

Ivanhoe, Victoria, Australia

Malvern East, Victoria, Australia

Morwell, Victoria, Australia

Countries

Australia

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)

Bird P, Peterfy C, Countryman P, Griffiths H, Barrett R, Youssef P, Joshua F, Hall S. AC-CUTE: An Open-Label Study to Evaluate Progression of Structural Joint Damage and Inflammation in Subjects with Moderate to Severe Rheumatoid Arthritis. Int J Rheumatol. 2018 Apr 12;2018:8721753. doi: 10.1155/2018/8721753. eCollection 2018.

Reference Type: DERIVED

PMID: 29849651 (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

ML28703

Identifier Type: -

Identifier Source: org_study_id