N/A
Completed N=120
A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01462162 ↗Enrolled (actual)
120
Serious AEs
2.5%
Results posted
Oct 2016
Primary outcomePrimary: Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12 — -2.200; -0.944; -0.707 unstandardized regression coefficient — p=0.006
Summary
This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12 |
-2.200; -0.944; -0.707 | 0.006 sig |
| PRIMARY Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24 |
-1.743; -0.990; -0.658 | 0.023 sig |
| SECONDARY Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F |
26.8; 4.6; 5.4 | <0.001 sig |
| SECONDARY Change From Baseline to Week 12 and 24 in Serum Hemoglobin |
12.3; 0.7; 12.4; 0.56 | <0.001 sig |
| SECONDARY Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24 |
-3.241; -2.596; 0.335; -0.242; -0.333; -0.600 | 0.003 sig |
| SECONDARY Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 |
-0.011; 0.028; 0.017; -0.055; 0.021; 0.013 | 0.678 |
| SECONDARY Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population |
0.025; 0.018; 0.019; -0.05; 0.022; 0.012 | 0.257 |
| SECONDARY Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population |
0.186; 0.005 | 0.077 |
| SECONDARY Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 |
5.9; 1.9; 6.0; 1.8 | <0.001 sig |
| SECONDARY Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population |
5.7; 2.1; 5.9; 1.8 | <0.001 sig |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Week 12, 24 |
1.4; 0.5; 1.4; 0.4 | <0.001 sig |
| SECONDARY Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population |
1.4; 0.5; 1.4; 0.4 | <0.001 sig |
| SECONDARY Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 |
6.8; 2.57; 6.8; 2.57 | <0.001 sig |
| SECONDARY Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population |
6.9; 2.59; 6.9; 2.69 | <0.001 sig |
| SECONDARY Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 |
6.0; 5.4; 6.1; 5.3 | 0.172 |
| SECONDARY Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population |
6.4; 6.0; 6.4; 5.4 | 0.162 |
| SECONDARY Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 |
17.4; 3.07; 3.5 | <0.001 sig |
| SECONDARY Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population |
18.3; 3.5; 18.5; 3.89 | <0.001 sig |
| SECONDARY Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 |
3.0; 2.53; 2.7; 2.73 | <0.001 sig |
| SECONDARY Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population |
5.6; 2.5; 2.7 | — |
| SECONDARY Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 |
56.1; 62.0; 95.5; 93.0 | — |
| SECONDARY Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population |
51; 61; 95.3; 94.6 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab according to his/her clinical judgment and the conditions approved in the Summary of Product Characteristics (SPC).
Exclusion Criteria
- Participants previously or currently treated with RoActemra/Actemra in clinical trials
- Absolute neutrophil count less than or equal to (</=) 2x10^9 per liter (/L)
Data sourced from ClinicalTrials.gov (NCT01462162). 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.