N/A
Completed N=37
Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia
Source: ClinicalTrials.gov NCT01683604 ↗Enrolled (actual)
37
Serious AEs
5.4%
Results posted
Jul 2016
Primary outcomePrimary: Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation — 79.3; 100; 80; 84.4 percentage of participants
Summary
This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation |
79.3; 100; 80; 84.4; 83.8 | — |
| PRIMARY Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline |
60.1; 47.2; 79.3; 55.3; 57.6 | — |
| PRIMARY Patient Global Assessment of Disease Activity Using VAS at Baseline |
69.6; 59.0; 85.0; 65.5; 67.5 | — |
| PRIMARY Physician Global Assessment of Disease Activity Using VAS at Baseline |
65.2; 63.3; 69.0; 64.4; 64.9 | — |
| PRIMARY Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline |
1.7; 1.7; 1.7; 1.7; 1.7 | — |
| PRIMARY Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline |
15.6; 14.7; 13.0; 15.8; 15.4; 34.4 | — |
| PRIMARY Erythrocyte Sedimentation Rate (ESR) at Baseline |
27.0; 35.2; 34.8; 27.3; 28.4 | — |
| PRIMARY C-Reactive Protein (CRP) at Baseline |
15.3; 22.6; 22.5; 16.0; 16.9 | — |
| SECONDARY Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs |
0; 100; 40; 18.8; 21.6; 31.0 | — |
| SECONDARY Median Dose at Month 6 |
8; 8; 8; 8; 8 | — |
| SECONDARY Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change |
0; 12.5; 0; 3.1; 2.7; 3.4 | — |
| SECONDARY Mean Dosing Interval at Month 6 |
30.97; 32.10; 29.63; 31.48; 31.22 | — |
| SECONDARY Percentage of Participants With Reasons Who Discontinued Tocilizumab |
20.0; 0; 25.0; 20.0; 40.0; 0 | — |
| SECONDARY Time to Restoration of Initial Dosing Regimen |
— | — |
| SECONDARY Percentage of Participants by Reason for Choice of Monotherapy at Baseline |
— | — |
| SECONDARY Percentage of Participants on Tocilizumab Monotherapy (8 mg/Kg) at Baseline and at Month 6 |
93.1; 100; 100.0; 93.8; 94.6; 87.0 | — |
| SECONDARY Duration of Tocilizumab Treatment |
181.1; 211.3; 174.8; 189.7; 187.6 | — |
| SECONDARY Percentage of Participants by Duration of Morning Stiffness |
4.5; 16.7; 0; 7.7; 7.1; 30.8 | — |
| SECONDARY Percentage of Participants With and Without Morning Stiffness |
95.8; 100; 100; 96.3; 96.7; 4.2 | — |
| SECONDARY Percentage of Participants Adhering to Local Label for Adverse Events |
100; 100; 100; 75; 80 | — |
| SECONDARY Disease Activity Score Based on 28 Joint Count (DAS28) Score by Visit |
6.34; 6.04; 6.73; 6.22; 6.28; 2.69 | — |
| SECONDARY Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 |
63.6; 66.7; 0; 69.2; 64.3; 50.0 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) Score by Visit |
46.41; 40.90; 45.40; 45.21; 45.23; 12.37 | — |
| SECONDARY Change From Baseline in TJC and SJC at Month 3 and Month 6 |
15.6; 14.7; 13.0; 15.8; 15.4; -13.9 | — |
| SECONDARY Simplified Disease Activity Index (SDAI) Score by Visit |
48.01; 43.57; 47.07; 47.06; 47.06; 13.29 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, or 70% (ACR20/50/70) Response at Month 3 and Month 6 From the Start of Tocilizumab Treatment |
90.9; 100.0; 100.0; 91.7; 92.9; 80.0 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 |
65.2; 63.3; 69.0; 64.4; 64.9; -40.8 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity at Months 3 and 6 |
69.6; 59.0; 85.0; 65.5; 67.5; -43.2 | — |
| SECONDARY Change From Baseline in HAQ-DI Score at Months 3 and 6 |
1.7; 1.7; 1.7; 1.7; 1.7; -0.5 | — |
| SECONDARY Change From Baseline in VAS-Fatigue at Months 3 and 6 |
59.0; 67.8; 86.3; 58.0; 60.7; -23.2 | — |
| SECONDARY Change From Baseline in Patient's Assessment of Pain at Months 3 and 6 |
60.1; 47.2; 79.3; 55.3; 57.6; -35.6 | — |
| SECONDARY Change From Baseline in Participant Assessment of Morning Stiffness Using VAS at Months 3 and 6 |
65.6; 57.3; 77.3; 62.5; 64.0; -30.7 | — |
Eligibility Criteria
Inclusion Criteria
- Severe RA.
- Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
- Participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit.
Exclusion Criteria
- Tocilizumab treatment more than 8 weeks prior to the enrolment visit.
- Previous tocilizumab treatment in a clinical trial or for compassionate use.
- Enrolled in an ongoing clinical trial and/or treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab.
- History of autoimmune disease or any joint inflammatory disease other than RA.
Data sourced from ClinicalTrials.gov (NCT01683604). 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.