An Open-Label Study to Evaluate Non-Progression Of Structural Joint Damage Of Subcutaneous Tocilizumab In Patients With Moderate To Severe Active Rheumatoid Arthritis (Ac-Cute)

Hoffmann-La Roche0 sites52 target enrollmentNovember 2013

ConditionsRheumatoid Arthritis

InterventionsTocilizumab

DrugsTocilizumab

Overview

Phase: Phase 3
Intervention: Tocilizumab
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 52
Primary Endpoint: Change From Baseline in Genant-modified Total Sharp Score (mTSS)
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

August 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Arms & Interventions

Tocilizumab

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

Intervention: Tocilizumab

Outcomes

Primary Outcomes

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

Time Frame: From baseline to Week 24

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.

Secondary Outcomes

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 Swollen Joint Count (SJC)(From baseline to Week 24)
Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions(From baseline to 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 Health Assessment Questionnaire-Disability Index (HAQ-DI)(From baseline to Week 24)
Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission(At 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)
Change From Baseline in Physician Global Assessment of Disease Activity(From baseline to Week 24)
Change From Baseline in Simplified Disease Activity Index (SDAI)(From baseline to Week 24)
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(From baseline to Week 24)
Change From Baseline in Clinical Disease Activity Index (CDAI)(From baseline to Week 24)
Change From Baseline in Total Tender Joint Count (TJC)(From baseline to Week 24)
Change From Baseline in RAMRIS Scoring of Osteitis(From baseline to Week 24)
Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal(Up to Week 32 (end of follow up: 8 weeks after end of treatment))
Change From Baseline in RAMRIS Scoring of Cartilage Loss(From baseline to Week 24)
Change From Baseline in RAMRIS Scoring of Synovitis(From baseline to Week 24)
Safety: Percentage of Participants With Adverse Events (AEs)(Up to Week 32 (end of follow up: 8 weeks after end of treatment))
Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity(At baseline, Week 32 (end of follow up: 8 weeks after end of treatment))