Phase 3
Completed N=57
TOSCARA Study: A Study of Subcutaneous Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis Naïve to RoActemra/Actemra Treatment
Source: ClinicalTrials.gov NCT02031471 ↗Enrolled (actual)
57
Serious AEs
8.8%
Results posted
Jan 2017
Primary outcomePrimary: Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Full Analysis Set (FAS) — 5.55; -3.24 Units on a scale
◆ Published Evidence
Established
37citations · ~5 / year
Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries.
Summary
This open-label, single-arm study will evaluate the efficacy, safety and tolerability of subcutaneously administered tocilizumab in monotherapy and/or in combination with methotrexate and other non-biologic disease modifying anti-rheumatic drug (DMARDs) in participants with active rheumatoid arthritis (RA) who are naïve to tocilizumab. Participants will receive tocilizumab 162 milligram (mg) subcutaneously weekly for 24 weeks. Participants who complete the core study achieving at least a moderate European League Against Rheumatism (EULAR) response at Week 24 may enter the extension phase and receive for a further 28 weeks at the most.
Linked Publications (2)
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Subcutaneous tocilizumab in rheumatoid arthritis: findings from the common-framework phase 4 study programme TOZURA conducted in 22 countries.
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Effects of concomitant glucocorticoids in TOZURA, a common-framework study programme of subcutaneous tocilizumab in rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Full Analysis Set (FAS) |
5.55; -3.24 | — |
| PRIMARY Change From Baseline in Disease Activity Score 28 - Erythrocyte Sedimentation Rate (DAS28-ESR) Score in the Per Protocol Set (PPS) |
5.73; -3.21 | — |
| SECONDARY Percentage of Participants With Positive American College of Rheumatology (ACR) Response Scores |
0; 21.6; 84.6; 100; 0; 1.9 | — |
| SECONDARY Percentage of Participants With Responses According to European League Against Rheumatism (EULAR ) Criteria |
17.9; 76.2; 50.0; 19.0; 32.1; 4.8 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI)/Clinical Disease Activity Index (CDAI) |
33.26; -9.00; -25.33; -34.04; 31.86; -7.61 | — |
| SECONDARY Change in Total Tender/Swollen Joint Counts (TJC/SJC) |
16.02; -3.58; -12.10; -17.25; 10.20; -3.93 | — |
| SECONDARY Percentage of Participants With Corticosteroid Dose Reduction/Discontinuation |
50.0 | — |
| SECONDARY Percentage of Participants Achieving CDAI Remission, CDAI Low Disease Activity, Moderate Disease Activity and High Disease Activity |
0; 1.8; 30.2; 37.5; 0; 7.1 | — |
| SECONDARY Percentage of Participants Achieving SDAI Remission, SDAI LDA, Moderate Disease Activity and High Disease Activity |
0; 1.8; 30.0; 42.9; 0; 7.3 | — |
| SECONDARY Percentage of Participants Achieving DAS28-ESR Remission, DAS28-ESR LDA, Moderate Disease Activity and High Disease Activity |
0; 7.1; 64.3; 87.5; 1.8; 16.1 | — |
| SECONDARY Percentage of Participants Achieving a Clinically Significant Improvement in DAS28 |
66.1; 90.5; 100 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity VAS |
64.93; -16.34; -48.93; -57.44 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity VAS |
67.28; -11.82; -36.02; -44.78 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain VAS |
66.77; -11.32; -35.37; -49.33 | — |
| SECONDARY Acute Phase Reactants: Change From Baseline in CRP |
13.79; -13.19; -10.12; -25.07 | — |
| SECONDARY Acute Phase Reactants: Change From Baseline in ESR |
33.75; -19.95; -22.80; -27.78 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) |
1.44; -0.08; -0.54; -1.33 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) |
26.09; 2.32; 10.53; 20.89 | — |
| SECONDARY Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) |
8.81; -1.24; -2.63; -4.56 | — |
| SECONDARY Change From Baseline in Patient Quality of Sleep VAS |
54.95; -8.40; -21.93; -34.22 | — |
| SECONDARY Change From Baseline in Arthritis Impact Measurement Scale-Short Form (AIMS-SF) |
3.57; -0.57; -1.41; -3.62; 6.33; -1.15 | — |
| SECONDARY Change From Baseline in Patient Fatigue VAS |
60.19; -3.74; -21.48; -50.89 | — |
| SECONDARY Change From Baseline in Patient Satisfaction VAS |
39.66; 9.49; 33.07; 49.38 | — |
| SECONDARY Change From Baseline in Work Instability Scale for Rheumatoid Arthritis (RA-WIS) |
13.15; -3.55 | — |
| SECONDARY Treatment Satisfaction Questionnaire for Medication (TSQM ) Scores |
66.7; 76.09; 65.06 | — |
| SECONDARY Safety: Percentage of Participants With Adverse Events |
96.5 | — |
| SECONDARY Safety: Percentage of Participants With Anti-tocilizumab Antibodies |
0; 1.7 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Active moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (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 participants may also be inadequate responders to a maximum of one biologic DMARD
- Oral corticosteroids ( /= 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 tocilizumab
- 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 long term extension (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 Tuberculosis (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
Data sourced from ClinicalTrials.gov (NCT02031471) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.