N/A
Completed N=68
A Non-Interventional Study of Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab) in Monotherapy
Source: ClinicalTrials.gov NCT01705730 ↗Enrolled (actual)
68
Serious AEs
4.4%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation — 79.4 percentage of participants
Summary
This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in participants with rheumatoid arthritis. Eligible participants initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation |
79.4 | — |
| SECONDARY Percentage of Participants With Systemic Manifestations of RA at Baseline |
— | — |
| SECONDARY Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response |
1; 67 | — |
| SECONDARY Number of Participants With Inadequate Response to Other Biologics |
35 | — |
| SECONDARY Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs) |
84 | — |
| SECONDARY Percentage of Participants Who Had DMARDs During Study |
0.0; 0.0; 100.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Number of Participants With Dose Reductions |
4 | — |
| SECONDARY Number of Participants With Starting Tocilizumab After Failing DMARDs |
33 | — |
| SECONDARY Number of Participants With Starting Tocilizumab After Stopping Other Biologic Agents |
35 | — |
| SECONDARY Time to Reduction/Withdrawal of Corticosteroids |
— | — |
| SECONDARY Number of Dose Modifications Per Participant at Month 6 |
0.1 | — |
| SECONDARY Mean Dosing Interval Per Participant at Month 6 |
25.86 | — |
| SECONDARY Percentage of Participants Discontinued From Tocilizumab for Safety Versus Efficacy |
61.5; 7.7; 30.8 | — |
| SECONDARY Time for Restoration of Initial Dosing Regimen |
NA | — |
| SECONDARY Percentage of Participants Who Were Not Adhering to Recommended Dosing Regimen |
20.6 | — |
| SECONDARY Number of Participants Who Were Not Adhering to Recommended Management of AEs |
— | — |
| SECONDARY Percentage of Participants Still on Tocilizumab Monotherapy at Month 6 |
98.1 | — |
| SECONDARY Percentage of Participants With Reason for Choice of Monotherapy at Baseline |
61.8; 38.2 | — |
| SECONDARY Tender Joint Count (TJC) |
10.3; 2.9; 2.2; 8.6; 2.0; 0.0 | — |
| SECONDARY Swollen Joint Count (SJC) |
7.9; 1.5; 0.9; 8.9; 0.6; 0.0 | — |
| SECONDARY Percentage of Participants With Disease Activity Score-28 (DAS28) |
0; 73.7; 81.8; 0; 68.4; 81.8 | — |
| SECONDARY Percentage of Participants With Good European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 |
90; 80 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 |
— | — |
| SECONDARY Percentage of Participants With Disease Activity According to Clinical Disease Activity Index (CDAI) Response |
0; 75.0; 75.0; 13.3; 25.0; 25.0 | — |
| SECONDARY Percentage of Participants With Disease Activity According to Simplified Disease Activity Index (SDAI) Response |
0; 75.0; 75.0; 17.9; 25.0; 25.0 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 |
65.6; -27.8; -30.1 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 |
57.6; -41.9; -53.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire (HAQ) at Month 3 and Month 6 |
41.11; -23.59; -11.94 | — |
| SECONDARY Change From Baseline in VAS-Fatigue at Month 3 and Month 6 |
64; -19.3; -38.4 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 |
60.6; -31.8; -33.0 | — |
| SECONDARY Change From Baseline in VAS-Morning Stiffness at Month 3 and Month 6 |
37.8; -7.6; -30.3 | — |
| SECONDARY Percentage of Participants With an Adverse Event (AEs), Serious Adverse Events (SAEs), AEs of Special Interest (AESIs) |
61.8; 4.4; 8.8 | — |
| SECONDARY Percentage of Participants With AEs Leading to Dose Modifications |
7.4 | — |
| SECONDARY C-reactive Protein (CRP]) Level |
9.94; 5.04; 2.49 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) Level |
24.31; 12.71; 8.88 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
- Concomitant treatment with NSAIDs and/or corticosteroids is allowed
Exclusion Criteria
- Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
- Participants who have received treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01705730). 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.