Overview

This trial has been completed.

Condition rheumatoid arthritis
Treatment tocilizumab [roactemra/actemra]
Phase phase 3
Sponsor Hoffmann-La Roche
Start date July 2014
End date October 2016
Trial size 285 participants
Trial identifier NCT02011334, ML28700

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
tocilizumab [roactemra/actemra]
162 mg will be administered once weekly by subcutaneous injection.

Primary Outcomes

Measure
Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate
time frame: 24 weeks

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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 (/= 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. - Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, 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 (Appendix 2). - Diagnosis of juvenile idiopathic arthritis or juvenile RA, and/or RA before the age of 16. - Prior history of or current inflammatory joint disease other than RA. - Previous exposure to RoActemra/Actemra (either IV or SC). - Prior treatment with a biologic agent. - 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 or 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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.