N/A
N=850
Use of Tocilizumab for Rheumatoid Arthritis (RA) in Daily Routine
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT02809833 ↗Enrolled (actual)
850
Serious AEs
12.2%
Results posted
Oct 2016
Primary outcome: Primary: Percentage of Participants With Categorized Laboratory Data Available at Baseline — 98.6; 49.2; 63.5; 7.3 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Tocilizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- Mar 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Categorized Laboratory Data Available at Baseline |
98.6; 49.2; 63.5; 7.3; 82.9 | — |
| PRIMARY Percentage of Participants With Categorized Laboratory Data Available at Week 24 |
87.6; 31.6; 42.6; 4.2; 58.9 | — |
| PRIMARY Percentage of Participants With Categorized Laboratory Data Available at Week 52 |
86.4; 29.0; 39.9; 5.6; 60.1 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 4 |
0.7; 14.5; 0.4; 14.8; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 8 |
0.0; 13.2; 0.8; 11.9; 0.0; 0.4 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 12 |
0.0; 18.3; 1.3; 16.5; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 16 |
0.9; 16.8; 0.5; 16.8; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 20 |
0.6; 18.9; 1.1; 18.3; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 24 |
0.5; 15.9; 0.0; 16.4; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 28 |
0.0; 15.6; 0.6; 15.0; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 32 |
1.2; 12.3; 0.6; 12.9; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 36 |
0.7; 19.6; 0.0; 20.3; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 40 |
0.0; 20.3; 0.0; 20.3; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 44 |
0.7; 15.7; 0.0; 16.4; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 48 |
1.5; 16.2; 0.0; 17.6; 0.0; 0.0 | — |
| PRIMARY Percentage of Participants With or Without Tocilizumab Dose Adjustment or Interruption at Week 52 |
1.9; 18.1; 2.5; 17.5; 0.0; 0.6 | — |
| PRIMARY Percentage of Participants With Tocilizumab Dose Adjustments by Reason |
54.3; 11.1; 10.6; 9.0; 8.5; 6.5 | — |
| PRIMARY 28-Joint Disease Activity Score (DAS28) at Baseline |
5.5 | — |
| PRIMARY Change in DAS28 From Baseline to Week 4 |
-1.8 | — |
| PRIMARY Change in DAS28 From Baseline to Week 8 |
-2.3 | — |
| PRIMARY Change in DAS28 From Baseline to Week 12 |
-2.4 | — |
| PRIMARY Change in DAS28 From Baseline to Week 16 |
-2.6 | — |
| PRIMARY Change in DAS28 From Baseline to Week 20 |
-2.6 | — |
| PRIMARY Change in DAS28 From Baseline to Week 24 |
-2.7 | — |
| PRIMARY Change in DAS28 From Baseline to Week 28 |
-2.7 | — |
| PRIMARY Change in DAS28 From Baseline to Week 32 |
-2.8 | — |
| PRIMARY Change in DAS28 From Baseline to Week 36 |
-2.9 | — |
| PRIMARY Change in DAS28 From Baseline to Week 40 |
-2.8 | — |
| PRIMARY Change in DAS28 From Baseline to Week 44 |
-3.0 | — |
| PRIMARY Change in DAS28 From Baseline to Week 48 |
-2.9 | — |
| PRIMARY Change in DAS28 From Baseline to Week 52 |
-2.9 | — |
| PRIMARY TJC at Baseline |
9.5 | — |
| PRIMARY Change in TJC From Baseline to Week 12 |
-5.2 | — |
| PRIMARY Change in TJC From Baseline to Week 24 |
-6.2 | — |
| PRIMARY Change in TJC From Baseline to Week 36 |
-6.6 | — |
| PRIMARY Change in TJC From Baseline to Week 52 |
-6.7 | — |
| PRIMARY SJC at Baseline |
8.1 | — |
| PRIMARY Change in SJC From Baseline to Week 12 |
-4.6 | — |
| PRIMARY Change in SJC From Baseline to Week 24 |
-5.2 | — |
| PRIMARY Change in SJC From Baseline to Week 36 |
-6.0 | — |
| PRIMARY Change in SJC From Baseline to Week 52 |
-6.0 | — |
| PRIMARY VAS Score of Participant-Assessed Disease Activity at Baseline |
66.8 | — |
| PRIMARY Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 12 |
-28.0 | — |
| PRIMARY Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 24 |
-32.0 | — |
| PRIMARY Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 36 |
-36.0 | — |
| PRIMARY Change in VAS Score of Participant-Assessed Disease Activity From Baseline to Week 52 |
-36.4 | — |
| PRIMARY VAS Score of Physician-Assessed Disease Activity at Baseline |
62.7 | — |
| PRIMARY Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 12 |
-29.6 | — |
| PRIMARY Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 24 |
-34.5 | — |
| PRIMARY Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 36 |
-37.3 | — |
| PRIMARY Change in VAS Score of Physician-Assessed Disease Activity From Baseline to Week 52 |
-38.5 | — |
| PRIMARY Percentage of Participants With European League Against Rheumatism (EULAR) Response at Week 4 |
31.8; 44.2; 24.0 | — |
| PRIMARY Percentage of Participants With EULAR Response at Week 12 |
50.0; 36.3; 13.7 | — |
| PRIMARY Percentage of Participants With EULAR Response at Week 24 |
54.8; 33.2; 12.1 | — |
| PRIMARY Percentage of Participants With EULAR Response at Week 36 |
60.3; 28.5; 11.2 | — |
| PRIMARY Percentage of Participants With EULAR Response at Week 52 |
62.3; 26.6; 11.0 | — |
| PRIMARY Percentage of Participants With Low Disease Activity Score (LDAS) According to DAS28 at Baseline |
5.1 | — |
| PRIMARY Percentage of Participants With LDAS According to DAS28 at Week 12 |
55.1 | — |
| PRIMARY Percentage of Participants With LDAS According to DAS28 at Week 24 |
59.3 | — |
| PRIMARY Percentage of Participants With LDAS According to DAS28 at Week 36 |
65.3 | — |
| PRIMARY Percentage of Participants With LDAS According to DAS28 at Week 52 |
66.4 | — |
| PRIMARY Percentage of Participants With Remission According to DAS28 at Baseline |
2.5 | — |
| PRIMARY Percentage of Participants With Remission According to DAS28 at Week 12 |
41.8 | — |
| PRIMARY Percentage of Participants With Remission According to DAS28 at Week 24 |
45.7 | — |
| PRIMARY Percentage of Participants With Remission According to DAS28 at Week 36 |
52.4 | — |
| PRIMARY Percentage of Participants With Remission According to DAS28 at Week 52 |
55.1 | — |
| PRIMARY Percentage of Participants With Minimum Clinically Important Improvement (MCII) According to DAS28 at Week 12 |
76.7 | — |
| PRIMARY Percentage of Participants With MCII According to DAS28 at Week 24 |
82.0 | — |
| PRIMARY Percentage of Participants With MCII According to DAS28 at Week 36 |
84.0 | — |
| PRIMARY Percentage of Participants With MCII According to DAS28 at Week 52 |
84.7 | — |
| SECONDARY Percentage of Participants With AEs Considered Causally Related to Tocilizumab |
39.4; 3.4; 2.9; 2.4; 2.1; 1.9 | — |
Summary
This prospective, multicenter, non-interventional study will enroll participants from routine clinical practice in Germany who are receiving tocilizumab for RA. The objective of the study is systematic collection of data on use of tocilizumab in daily routine with special emphasis on treatment decision by the prescriber, compliance with Summary of Product Characteristics (SmPC), and documentation of relevant activity scores and adverse drug reactions (ADRs). The maximum observation period will be 12 months per participant.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe RA
- Tocilizumab indicated in accordance with SmPC and chosen by the treating physician in advance of the study
Exclusion Criteria
- None specified
Data sourced from ClinicalTrials.gov (NCT02809833). 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.