N/A
Completed N=1,224
An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01543503 ↗Enrolled (actual)
1,224
Serious AEs
7.1%
Results posted
Feb 2016
Primary outcomePrimary: Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24 — -2.795; -1.945 Units on a scale — p=<0.001
Summary
This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24 |
-2.795; -1.945 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52 |
-3.015; -2.105 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Erythrocyte Sedimentation Rate |
-22.732; -9.502; -21.515; -8.868 | <0.001 sig |
| SECONDARY Mean Change From Baseline in C-reactive Protein |
-11.005; -4.333; -6.332; -5.216 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Swollen Joint Count |
-5.698; -5.122; -6.313; -5.561 | 0.024 sig |
| SECONDARY Mean Change From Baseline in Tender Joint Count |
-7.922; -7.302; -8.421; -7.205 | 0.123 |
| SECONDARY Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score |
-20.251; -16.776; -22.846; -18.246; -21.394; -18.164 | <0.001 sig |
| SECONDARY Mean Change From Baseline in Physician Global Assessment Score |
-35.581; -26.551; -37.359; -27.122 | <0.001 sig |
| SECONDARY Loss of Efficacy or Development of Intolerance to Biologic Therapy |
15; 106 | — |
| SECONDARY Proportion of Participants Who Terminated Biologic Treatment |
14.9; 27.4 | — |
| SECONDARY Reasons for Treatment Discontinuation |
24; 87; 15; 106; 24; 23 | — |
| SECONDARY Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period |
36; 119; 61; 208; 62; 212 | <0.001 sig |
| SECONDARY Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy |
33; 75; 4; 3 | — |
| SECONDARY Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events |
208; 449; 22; 64; 196; 421 | — |
| SECONDARY Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study |
13; 27; 22; 16 | — |
| SECONDARY Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score |
-0.591; -0.445; -0.593; -0.430 | 0.020 sig |
| SECONDARY Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score |
-7.153; -3.260; -4.566; -1.779 | 0.032 sig |
| SECONDARY Mean Change From Baseline in Visual Analogue Scale Pain Score |
-29.308; -23.647; -32.957; -23.155 | 0.009 sig |
| SECONDARY Shift From Baseline in Morning Stiffness |
13; 19; 1; 8; 2; 1 | — |
| SECONDARY Change From Baseline in Patient Global Assessment of Disease Activity |
-29.633; -24.525; -31.919; -24.153 | 0.010 sig |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 years of age
- Diagnosis of rheumatoid arthritis
- Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
- Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed
Exclusion Criteria
- Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
- Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
- Patients whose first biologic is rituximab, abatacept or anakinra.
- Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit
Data sourced from ClinicalTrials.gov (NCT01543503). 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.