N/A
Completed N=184
Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01579006 ↗Enrolled (actual)
184
Serious AEs
9.2%
Results posted
Jan 2016
Primary outcomePrimary: Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation — 42.4 percentage of participants
Summary
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation |
42.4 | — |
| PRIMARY Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation |
85.9 | — |
| SECONDARY Percentage of Participants With Systemic Manifestations of RA at Baseline |
8.7; 22.3; 6.5; 21.8; 8.1; 3.2 | — |
| SECONDARY Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study |
0.6; 2.2; 33.3; 7.9; 24.5; 29.2 | — |
| SECONDARY Percentage of Participants With Reason for DMARD Withdrawal |
27.3; 22.7; 17.3; 32.7; 60.0; 14.8 | — |
| SECONDARY Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study |
53.8; 38.6; 7.1; 0.5 | — |
| SECONDARY Percentage of Participants With Type of Previous Biologic RA Treatments |
15.2; 8.2; 4.3; 17.4; 1.6; 7.6 | — |
| SECONDARY Duration of Previous Biologic RA Treatments |
0.9; 2.5; 1.6; 1.7; 4.9; 1.4 | — |
| SECONDARY Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments |
85.7; 10.7; 3.6; 53.3; 26.7; 20.0 | — |
| SECONDARY Percentage of Participants With Dose Modifications |
0.0; 2.8; 2.3; 1.8; 1.9; 3.3 | — |
| SECONDARY Percentage of Participants With Reasons for Dose Modification |
80.0; 20.0; 100.0; 66.7; 33.3; 100.0 | — |
| SECONDARY Mean Dose at 6 Months |
8.0; 7.9; 7.9; 7.9; 7.9; 7.9 | — |
| SECONDARY Mean Number of Dose Modifications at 6 Months |
1.7 | — |
| SECONDARY Mean Dosing Interval of Treatment at 6 Months |
31.4; 30.8; 31.4; 31.8; 31.9 | — |
| SECONDARY Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy |
6.0; 6.5; 5.4 | — |
| SECONDARY Time to Restoration of Initial Dosing Regimen |
81.6 | — |
| SECONDARY Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician |
8.2 | — |
| SECONDARY Percentage of Participants on TCZ Monotherapy |
32.6; 34.3; 35.6; 38.0; 38.6; 41.7 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6 |
-10.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6 |
-6.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6 |
-2.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6 |
56.5; 28.3; 15.2 | — |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6 |
-18.7 | <0.0001 sig |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6 |
-17.3 | <0.0001 sig |
| SECONDARY Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6 |
54.8 | — |
| SECONDARY Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6 |
32.3 | — |
| SECONDARY Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6 |
9.7 | — |
| SECONDARY Change From Baseline in CRP at Month 6 |
-1.6 | — |
| SECONDARY Change From Baseline in ESR at Month 6 |
-34.4 | — |
| SECONDARY Change From Baseline in PhGH at Month 6 |
-34.0 | <0.0001 sig |
| SECONDARY Change From Baseline in PGH of Disease Activity at Month 6 |
-26.5 | <0.0001 sig |
| SECONDARY Change From Baseline in HAQ-DI at Month 6 |
-0.3 | <0.0001 sig |
| SECONDARY Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6 |
-17.9 | <0.0001 sig |
| SECONDARY Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6 |
-23.7 | <0.0001 sig |
| SECONDARY Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6 |
7.3; 11.7; 11.9; 17.3; 20.0 | — |
| SECONDARY Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6 |
-26.6 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis
- Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
- Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit
Exclusion Criteria
- RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
- Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- Enrolled in an ongoing clinical trial and/or 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 (NCT01579006). 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.