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

NCT01951170 | Completed Phase 3 Results

• 1 other identifier: ML28703
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 10

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Genant-modified Total Sharp Score (mTSS)

  The mTSS is a measure of joint damage that combines scores for bone erosion and joint-space narrowing (JNS). Erosion score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=normal to 3.5=very severe erosion. JNS score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=normal to 4.0=definite ankylosis (stiffness or fixation of a joint). mTSS scores ranged from 0 (normal) to 292 (worst possible total score). Change from baseline = mTSS score at Week 24 minus score at baseline. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

  From baseline to Week 24

Secondary Outcomes (19)

• Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission

  At Week 24

• Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses

  From baseline to Week 24

• Percentage of Participants With European League Against Rheumatism (EULAR) Response

  From baseline to Week 24

• Change From Baseline in Patient's Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)

  From baseline to Week 24

• Change From Baseline in Patient's Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)

  From baseline to Week 24

Study Arms (1)

Tocilizumab

EXPERIMENTAL

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

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

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

Also known as: RoActemra®/Actemra®

Tocilizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (10)

Unknown Facility

Camperdown, New South Wales, 2050, Australia

Location

Unknown Facility

Coffs Harbour, New South Wales, 2450, Australia

Location

Unknown Facility

Kogarah, New South Wales, 2217, Australia

Location

Unknown Facility

Southport, Queensland, 4215, Australia

Location

Unknown Facility

Adelaide, South Australia, 5000, Australia

Location

Unknown Facility

Hobart, Tasmania, 7000, Australia

Location

Unknown Facility

Geelong, Victoria, 3220, Australia

Location

Unknown Facility

Ivanhoe, Victoria, 3079, Australia

Location

Unknown Facility

Malvern East, Victoria, 3145, Australia

Location

Unknown Facility

Morwell, Victoria, 3842, Australia

Location

Related Publications (3)

• 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.

  PMID: 30649524 DERIVED

• 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.

  PMID: 29849651 DERIVED

• 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.

  PMID: 29244149 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800 821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2013
• First Posted: September 26, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 21, 2016
• Results First Posted: September 21, 2016

Record last verified: 2016-08

Locations

AU (10)