A Study Assessing the Safety and Efficacy of Subcutaneous RoActemra/Actemra Alone or in Combination With Non-biologic Antirheumatics in Rhuematoid Arthritis Patients in Latin America With Inadequate Response to Non-biologic Antirheumatic Drugs.

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02011334
• Other study ID #: ML28700
• Status: Completed
• Phase: Phase 3
• First received: December 4, 2013
• Last updated: November 1, 2016
• Start date: July 2014
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 285
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

• 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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• tocilizumab [RoActemra/Actemra]
162 mg will be administered once weekly by subcutaneous injection.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Brazil,  Colombia,  Dominican Republic,  Mexico,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: Disease Activity Score 28-erythrocyte sedimentation rate (DAS28-ESR) Remission Rate		24 weeks	No
Secondary	Safety: Incidence of adverse events (AE)		60 weeks	No
Secondary	Efficacy: Change in DAS28-ESR		From baseline to Week 52	No
Secondary	Efficacy: ACR/EULAR responses		52 weeks	No
Secondary	Efficacy: Change in disease activity (CDAI/SDAI)		From baseline to Week 52	No
Secondary	Efficacy: Change in joint swelling/tenderness (SJC/TJC)		From baseline to Week 52	No
Secondary	Safety: Assessment of immunogenicity		60 weeks	No
Secondary	Patient-reported outcomes		60 weeks	No
Secondary	Efficacy: DAS28-ESR Remission Rate		52 weeks	No
Secondary	Efficacy: Proportion of patients who maintain DAS28 Remission/LDA		From Week 24 to Week 52	No
Secondary	Safety: Rates of AE leading to dose modification or study withdrawal		52 weeks	No
Secondary	Safety: Assessment of physical examination and vital signs		52 weeks	No
Secondary	Safety: Incidence of clinically significant laboratory abnormalities following treatment		52 weeks	No