N/A
Completed N=23
A Non-Interventional Study in Patients With Moderate to Severe Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)
Source: ClinicalTrials.gov NCT01663506 ↗Enrolled (actual)
23
Serious AEs
17.4%
Results posted
Dec 2015
Primary outcomePrimary: Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation — 73.9 percentage of participants
Summary
This non-interventional study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed for 12 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Tocilizumab Treatment at 6 Months After Treatment Initiation |
73.9 | — |
| SECONDARY Percentage of Participants With Tocilizumab Treatment at 12 Months After Treatment Initiation |
69.6 | — |
| SECONDARY Percentage of Participants With Tocilizumab Dose Modification, Interruption, and Irregularity |
26.1; 39.1; 39.1 | — |
| SECONDARY Number of Participants With Comorbidities at Baseline |
1; 1; 1; 3; 2; 1 | — |
| SECONDARY Number of Participants With Prior Exposure to Disease Modifying Anti-rheumatic Drugs (DMARDs) |
1; 1; 5; 7; 5; 4 | — |
| SECONDARY Number of Participants With Prior Exposure of Biologics |
12; 8; 3 | — |
| SECONDARY Disease Activity Score Based on 28-joints Count (DAS28) |
5.35; 3.54; 2.91; 2.29 | <0.01 sig |
| SECONDARY Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 |
6; 8; 4; 11; 2; 3 | — |
| SECONDARY Physician Global Assessment (PGA) of Disease Activity |
58.40; 27.00; 13.80 | <0.001 sig |
| SECONDARY Patient Global Assessment (PtGA) of Disease Activity Score |
62.68; 36.85; 22.27 | <0.05 sig |
| SECONDARY Health Assessment Questionnaire-Disability Index (HAQ-DI) Score |
1.22; 0.98; 0.65 | — |
| SECONDARY Visual Analog Scale (VAS)-Pain |
56.18; 35.00; 22.91 | <0.05 sig |
| SECONDARY Visual Analog Fatigue Scale (VAFS) |
67.00; 39.80; 5.67 | <0.01 sig |
| SECONDARY Visual Analog Scale-Morning Stiffness (VAS-MS) |
67.00; 23.60; 16.00 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) |
36.83; 9.81; 6.54 | <0.001 sig |
| SECONDARY C-Reactive Protein (CRP) |
30.16; 8.54; 4.07 | <0.05 sig |
| SECONDARY Number of Swollen and Tender Joints Based on 66 and 68 Joints |
4.29; 6.86; 0; 0; 1.00; 2.00 | — |
| SECONDARY Number of Swollen and Tender Joints Based on 28 Joints |
6.78; 9.13; 2.56; 4.11; 1.54; 1.92 | <0.01 sig |
| SECONDARY Simplified Disease Activity Index (SDAI) Score |
31.99; 13.69; 7.17 | <0.01 sig |
| SECONDARY Clinical Disease Activity Index (CDAI) Score |
28.68; 13.12; 6.77 | <0.01 sig |
| SECONDARY Number of Participants Who Received Tocilizumab as Monotherapy |
2; 9 | — |
| SECONDARY Number of Participants Who Received Tocilizumab in Combination With Disease Modifying Anti-rheumatic Drugs (DMARDs) |
21; 14 | — |
| SECONDARY Number of Participants Receiving Oral Corticosteroids |
18; 14; 12; 9 | — |
| SECONDARY Number of Participants With Disease Activity Status Based on DAS28 Score |
1; 1; 4; 16; 5; 3 | — |
| SECONDARY Number of Participants With Disease Activity Status Based on SDAI Score |
5; 15; 5; 8; 3; 3 | — |
| SECONDARY Number of Participants With Disease Activity Status Based on CDAI Score |
5; 15; 4; 9; 4; 3 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 week prior to the enrolment visit
Exclusion Criteria
- Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01663506). 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.