N/A
Completed N=291
A Non-Interventional Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01672970 ↗Enrolled (actual)
291
Serious AEs
5.9%
Results posted
Mar 2016
Primary outcomePrimary: Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation — 81 percentage of participants
Summary
This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the local label will be followed for 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation |
81 | — |
| SECONDARY Percentage of Participants With Systemic Manifestations of RA at Baseline |
13.8 | — |
| SECONDARY Percentage of Participants Who Stopped DMARDs Prior to Start of Study and at Baseline |
60.70 | — |
| SECONDARY Percentage of Participants With Reason for DMARDs Withdrawal at Baseline |
12.1; 22.1; 7.2; 19.3 | — |
| SECONDARY Number of Previous Biologic RA Treatments Received by Participants |
1; 4; 26; 83; 1; 16 | — |
| SECONDARY Percentage of Participants With Duration of Previous Biologic RA Treatments |
0.0; 100.0 | — |
| SECONDARY Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments |
42.1; 11.7; 4.5; 0.3 | — |
| SECONDARY Number of Participants With Reasons for Dose Modification for TCZ |
17; 3; 6 | — |
| SECONDARY Mean Dose of TCZ at 6 Months |
7.8926 | — |
| SECONDARY Mean Dosing Interval of Treatment at 6 Months |
31.79 | — |
| SECONDARY Percentage of Participants Discontinued From Tocilizumab for Safety And Efficacy Reasons |
6.2; 4.1; 5.5 | — |
| SECONDARY Number of Participants With Restoration of Initial Dosing Regimen of TCZ |
1; 1; 2; 1; 1 | — |
| SECONDARY Percentage of Participants Adhered to the Dosing Regimen Recommended by Physician for TCZ |
1.38; 1.38 | — |
| SECONDARY Percentage of Participants on Tocilizumab Monotherapy |
40.0 | — |
| SECONDARY Percentage of Participants With Reason for DMARD Withdrawal |
12.3; 67.1; 20.5; 0.7; 3.1 | — |
| SECONDARY Change From Baseline in Tender Joint Count (28 Joints) at Months 3 and 6 |
-10.2703; -10.6744 | 0.000 sig |
| SECONDARY Change From Baseline in Tender Joint Count (68 Joints) at Months 3 and 6 |
-48.2904; -60.0820 | 0.001 sig |
| SECONDARY Change From Baseline in Swollen Joint Count (28 Joints) at Months 3 and 6 |
-6.6641; -7.0651 | 0.000 sig |
| SECONDARY Change From Baseline in Swollen Joint Count (66 Joints) at Months 3 and 6 |
-70.6711; -80.9244 | 0.000 sig |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) at Months 3 and 6 |
2.6156; 2.2703 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response |
75.2; 7.2; 3.1; 0.7; 0.3; 0.3 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Months 3 and 6 |
-45.4383; -47.5846 | 0.000 sig |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Months 3 and 6 |
-24.6068; -26.0046 | 0.000 sig |
| SECONDARY Percentage of Participants Who Achieved 20 Percent (%) Improvement in ACR (ACR20) Response |
3.80; 4.5 | — |
| SECONDARY Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response |
3.10; 1.70 | — |
| SECONDARY Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response |
1.40; 1.40 | — |
| SECONDARY Percentage of Participants Who Achieved 90% Improvement in ACR (ACR90) Response |
0.70; 0.70 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 |
-37.3832; -43.9096 | 0.000 sig |
| SECONDARY Change From Baseline in Participant Global Assessment of Disease Activity at Months 3 and 6 |
-33.2437; -39.3930 | 0.000 sig |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Months 3 and 6 |
0.4766; 0.5497 | 0.000 sig |
| SECONDARY Change From Baseline in Participant's Assessment of Fatigue Using VAS at Months 3 and 6 |
-26.4192; -32.5000 | 0.000 sig |
| SECONDARY Change From Baseline in Participant's Assessment of RA-Related Pain Using VAS at Months 3 and 6 |
-31.0586; -36.9948 | 0.000 sig |
| SECONDARY Change From Baseline in Particpant's Assessment of RA Morning Stiffness Assessed Using VAS at Months 3 and 6 |
-25.7285; -32.5043 | 0.000 sig |
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 (NCT01672970). 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.