A MULTICENTER, OPEN LABEL STUDY TO EVALUATE EFFICACY AND SAFETY OF TOCILIZUMAB GIVEN SUBCUTANEOUSLY IN MONOTHERAPY AND IN COMBINATION WITH NON-BIOLOGIC DMARDS IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS IN LATIN AMERICA

Hoffmann-La Roche0 sites285 target enrollmentJuly 2014

ConditionsRheumatoid Arthritis

Interventionstocilizumab [RoActemra/Actemra]

Drugstocilizumab [RoActemra/Actemra]

Overview

Phase: Phase 3
Intervention: tocilizumab [RoActemra/Actemra]
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 285
Primary Endpoint: Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

October 2016

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

•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.

Arms & Interventions

RoActemra/Actemra

Intervention: tocilizumab [RoActemra/Actemra]

Outcomes

Primary Outcomes

Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate

Time Frame: 24 weeks

Secondary Outcomes

Safety: Incidence of adverse events (AE)(60 weeks)
Efficacy: Change in DAS28-ESR(From baseline to Week 52)
Efficacy: ACR/EULAR responses(52 weeks)
Efficacy: Change in joint swelling/tenderness (SJC/TJC)(From baseline to Week 52)
Efficacy: Change in disease activity (CDAI/SDAI)(From baseline to Week 52)
Safety: Assessment of immunogenicity(60 weeks)
Patient-reported outcomes(60 weeks)
Efficacy: DAS28-ESR Remission Rate(52 weeks)
Efficacy: Proportion of patients who maintain DAS28 Remission/LDA(From Week 24 to Week 52)
Safety: Rates of AE leading to dose modification or study withdrawal(52 weeks)
Safety: Assessment of physical examination and vital signs(52 weeks)
Safety: Incidence of clinically significant laboratory abnormalities following treatment(52 weeks)