TOSCARA Study: A Study of Subcutaneous RoActemra/Actemra (Tocilizumab) in Patients With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-label, Single Arm Study to Evaluate the Efficacy and Safety and Tolerability of Tocilizumab (TCZ) Subcutaneous in TCZ-naïve Patients With Active Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031471
• Other study ID #: ML28701
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2013
• Last updated: September 1, 2016
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: September 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Agence fédérale des médicaments et produits de santé
• Study type: Interventional

Clinical Trial Summary

This open-label, single-arm study will evaluate the efficacy and safety of subcutaneously administered RoActemra/Actemra (tocilizumab) in monotherapy and/or in combination with methotrexate and other non-biologic DMARDs in patients with active rheumatoid arthritis who are naïve to RoActemra/Actemra. Patients will receive RoActemra/Actemra 162 mg subcutaneously weekly for 24 weeks. Patients who complete the core study achieving at least a moderate EULAR response at Week 24 may enter the extension phase and receive RoActemra/Actemra for a further 28 weeks at the most.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Active moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria

• Inadequate response or intolerant to previous therapy with two or more non-biologic disease-modifying anti-rheumatic drugs (DMARDs), one of which is methotrexate, administered in an optimal way during at least 3 months; eligible patients may also be inadequate responders to a maximum of one biologic DMARD

• Oral corticosteroids (</= 10 mg/day prednisolone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs; up to the recommended dose) are permitted if on stable dose regimen for >/= 4 weeks prior to baseline

• Permitted DMARDs are allowed if at stable dose for at least 4 weeks prior to baseline

• Receiving treatment on an outpatient basis, not including RoActemra/Actemra

• Females of childbearing potential and males with female partners of childbearing potential must agree to use reliable means of contraception as defined by protocol

Exclusion Criteria:

• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following baseline or during LTE period

• Rheumatic autoimmune disease other than rheumatoid arthritis

• Functional Class IV as defined by the 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 or current inflammatory joint disease other than RA

• Exposure to tocilizumab (intravenous or subcutaneous) at any time prior to baseline

• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening

• Intraarticular or parenteral corticosteroids within 4 weeks prior to baseline

• History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies

• Evidence of serious concomitant disease or disorder

• Known active current or history of recurrent infection

• Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening

• Active TB requiring treatment within the previous 3 years

• Positive for hepatitis B or hepatitis C

• Primary or secondary immunodeficiency (history of or currently active)

• Pregnant or lactating women

• Neuropathies or other conditions that might interfere with pain evaluation

• Inadequate hematologic, renal or liver function

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 subcutaneously weekly

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) score		from baseline to Week 24	No
Secondary	Change in American College of Rheumatology (ACR) response scores		from baseline to Week 24	No
Secondary	Change in European League Against Rheumatism (EULAR) response criteria		from baseline to Week 24	No
Secondary	Change in Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI)		from baseline to Week 24	No
Secondary	Change in total tender/swollen joint count (TJC/SJC)		from baseline to Week 24	No
Secondary	Proportion of patients with corticosteroid dose reduction/discontinuation		24 weeks	No
Secondary	Percentage of patients achieving low disease activity, defined as DAS28 </= 3.2, CDAI </= 10.0, SDAI </= 11.0		24 weeks	No
Secondary	Percentage of patients achieving remission, defined as DAS28 </= 2.6, CDAI </= 2.8, SDAI </=3.3		24 weeks	No
Secondary	Percentage of patients achieving a clinically significant improvement in DAS28 (reduction of at least 1.2 units)		24 weeks	No
Secondary	Percentage of patients with major or minor improvement in SDAI/CDAI		24 weeks	No
Secondary	Safety: Incidence of adverse events		up to 60 weeks	No
Secondary	Safety: Incidence of anti-tocilizumab antibodies		up to 60 weeks	No
Secondary	Patient reported quality of life (Questionnaires: HAQ-DI, FACIT-F, PSQI, AIMS-SF, TSQM, RA-WIS, Visual Analogue Scales)		24 weeks	No