Phase 3
Completed N=133
A Study of Subcutaneous (SC) Tocilizumab (RoActemra/Actemra) in Participants With Active Rheumatoid Arthritis (RA) and Inadequate Response to Disease-Modifying Anti-Rheumatic Drugs (DMARDs)
Source: ClinicalTrials.gov NCT02046616 ↗Enrolled (actual)
133
Serious AEs
9.0%
Results posted
Apr 2018
Primary outcomePrimary: Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 — 24.9; -16.6 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 Phase IIIb, open-label, single-arm study will evaluate the safety, efficacy, and tolerability of SC tocilizumab (RoActemra/Actemra) in monotherapy or in combination with methotrexate or other non-biologic DMARDs in participants with active RA who are naive to tocilizumab. Participants will receive tocilizumab 162 milligrams (mg) subcutaneously weekly (QW) for 24 weeks.
Linked Publications (4)
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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.
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Major reduction of ultrasound-detected synovitis during subcutaneous tocilizumab treatment: results from a multicentre 24 week study of patients with rheumatoid arthritis.
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Rheumatoid arthritis patients with predominantly tender joints rarely achieve clinical remission despite being in ultrasound remission.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Clinical Disease Activity Index (CDAI) at Week 12 |
24.9; -16.6 | — |
| SECONDARY Change From Baseline in Disease Activity Score 28 (DAS28)-Erythrocyte Sedimentation Rate (ESR) Score |
5.0; -1.4; -2.1; -2.8; -2.9; -3.2 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) Response |
25.2; 51.5; 70.4; 70.8; 82.5; 77.2 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response |
29.1; 47.2; 23.6; 51.2; 39.5; 9.3 | — |
| SECONDARY Change From Baseline in CDAI at Weeks 2, 4, 8, 16, 20, and 24 |
-6.2; -10.5; -15.7; -18.8; -18.9; -19.0 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) |
35.76; -15.37; -20.32; -25.89; -26.19; -29.03 | — |
| SECONDARY Change From Baseline in TJC |
8.8; -2.1; -3.5; -5.8; -5.5; -6.7 | — |
| SECONDARY Change From Baseline in SJC |
6.8; -2.3; -3.1; -4.8; -5.3; -5.9 | — |
| SECONDARY Percentage of Participants With At Least One Adverse Event Leading to Dosage Modification |
18.80; 27.07 | — |
| SECONDARY Number of Participants With Neutralizing Anti-Tocilizumab Antibodies |
1 | — |
| SECONDARY Tocilizumab Concentration |
0.6; 47.4; 48.0; 32.8 | — |
| SECONDARY Soluble Interleukin-6 Receptor (sIL-6R) Concentration |
37.0; 509.4; 520.2; 166.0 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity According to VAS |
53.2; -6.8; -20.3; -24.6; -30.3; -32.3 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of RA-Related Pain According to VAS |
54.8; -9.1; -22.5; -28.9; -32.8; -35.6 | — |
| SECONDARY Change From Baseline in HAQ-DI Score |
1.2; -0.1; -0.3; -0.5; -0.5; -0.6 | — |
| SECONDARY Compliance With Treatment According to Percentage of Injections Administered |
86.78 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score |
32.9; 3.4; 5.7; 6.6; 7.6; 7.9 | — |
Eligibility Criteria
Inclusion Criteria
- Active RA according to the revised ACR (1987) criteria or EULAR/ACR (2010) criteria
- Moderate to severe RA with a DAS28-ESR score >3.2 points
- Inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
- Oral corticosteroids (less than or equal to [ /=] 4 weeks prior to baseline
- Permitted non-biologic DMARDs allowed if at stable dose for >/=4 weeks prior to baseline
- Receiving treatment on an outpatient basis, not including tocilizumab
- Agreement to use reliable means of contraception as defined by protocol, among females of childbearing potential and males with female partners of childbearing potential
Exclusion Criteria
- 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
- 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 or any other biologic DMARDs 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
- Intra-articular 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 intravenous (IV) antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks of screening
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for hepatitis B or hepatitis C
- History of or current active primary or secondary immunodeficiency
- 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 (NCT02046616) 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.