N/A
Completed N=603
An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice
Source: ClinicalTrials.gov NCT01474291 ↗Enrolled (actual)
603
Serious AEs
12.3%
Results posted
Oct 2016
Primary outcomePrimary: Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion — 228; 349 participants — p=0.0230
Summary
This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Assigned Tocilizumab Monotherapy Versus Tocilizumab as Part of Combination Therapy at Study Inclusion |
228; 349 | 0.0230 sig |
| SECONDARY Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Methotrexate (MTX) |
12.6; 4.4; 20.4; 46.1; 4.9; 8.7 | — |
| SECONDARY Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Leflunomide |
17.6; 47.1; 2.9; 32.4 | — |
| SECONDARY Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Sulfasalazine |
23.5; 41.2; 35.3 | — |
| SECONDARY Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Hydroxychloroquine |
30.0; 50.0; 20.0 | — |
| SECONDARY Percentage of Participants Receiving Tocilizumab Monotherapy Who Discontinued Unspecified Conventional Synthetic Disease-modifying Antirheumatic Drugs (csDMARDs) |
26.6; 38.0; 1.3; 27.8; 1.3; 5.1 | — |
| SECONDARY Mean Number of Tocilizumab Infusions Over the Study Period |
9.1; 9.7 | — |
| SECONDARY Percentage of Participants Who Received Tocilizumab Infusions Over the Study Period |
5.7; 4.6; 4.8; 4.0; 7.0; 2.6 | — |
| SECONDARY Percentage of Participants With No Modification of Tocilizumab Treatment Over the Study Period |
48.2; 56.2 | — |
| SECONDARY Percentage of Participants With at Least One csDMARD Intensification During the Study |
8.2; 4.7 | — |
| SECONDARY Percentage of Participants in Disease Activity Score Based on 28-joint Count and Erythrocyte Sedimentation Rate (DAS28-ESR) Low Disease Activity (LDA) at Month 12 |
41.2; 44.4 | — |
| SECONDARY Percentage of Participants With DAS28-ESR Remission at Month 12 |
34.6; 35.5 | — |
| SECONDARY Percentage of Participants With Clinical Disease Activity Index (CDAI) LDA at Month 12 |
31.1; 23.5 | — |
| SECONDARY Percentage of Participants With CDAI Remission at Month 12 |
9.6; 8.6 | — |
| SECONDARY Percentage of Participants With Simplified Disease Activity Index (SDAI) LDA at Month 12 |
30.7; 23.2 | — |
| SECONDARY Percentage of Participants With SDAI Remission at Month 12 |
10.1; 9.7 | — |
| SECONDARY Percentage of Participants With American College or Rheumatology (ACR)20, ACR50, and ACR70 at Month 12 |
32.5; 26.4; 21.9; 16.9; 9.6; 9.7 | — |
| SECONDARY Percentage of Participants With Good or Moderate European League Against Rheumatism (EULAR) Response at Month 12 |
40.4; 38.7; 9.6; 10.9 | — |
| SECONDARY Mean Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score |
1.62; 1.47; -0.45; -0.44; -0.47; -0.45 | — |
| SECONDARY Mean Change From Baseline in Rheumatoid Arthritis Impact of Disease (RAID) Score |
6.47; 5.92; -2.11; -2.07; -2.42; -2.15 | — |
| SECONDARY Percentage of Participants With Acceptable Health State Assessed by the Patient Acceptable Symptom State (PASS) Questionnaire. |
25.6; 34.1; 69.3; 73.2; 84.5; 79.5 | — |
| SECONDARY Percentage of Participants With Adverse Events |
54.7; 53.4 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Patients with rheumatoid arthritis for whom the rheumatologist decides to start tocilizumab in combination with DMARD or as monotherapy
Exclusion Criteria
- Current participation in a clinical trial in rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01474291). 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.