N/A
Completed N=50
A Non-interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01562327 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
Oct 2016
Primary outcomePrimary: Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation — 84 percentage of participants
Summary
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis. Data will be collected from each eligible participant initiated on RoActemra/Actemra treatment by their treating physician according to local label for 6 months from start of treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation |
84 | — |
| SECONDARY Percentage of Participants With Systemic Manifestations of RA at Baseline |
40 | — |
| SECONDARY Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab |
5 | — |
| SECONDARY Percentage of Participants Who Previously Received DMARDs |
48.00; 24.00; 14.00; 10.00; 0.00; 1 | — |
| SECONDARY Reason for DMARDs Withdrawal at Baseline |
2; 2; 1 | — |
| SECONDARY Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab |
19 | — |
| SECONDARY Percentage of Participants Who Previously Received Biologic Agents |
62.00; 16.00; 16.00; 4.00; 2.00 | — |
| SECONDARY Reason for Biologic Agent Withdrawal at Baseline |
13; 1; 2; 3 | — |
| SECONDARY Reasons for Dose Modifications |
1; 21 | — |
| SECONDARY Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy |
4; 2 | — |
| SECONDARY Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy |
14; 86; 14; 86 | — |
| SECONDARY Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6 |
12; -6; -9 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6 |
8; -5; -7.50 | — |
| SECONDARY Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6 |
0; 0; 0; 3; 2; 1 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6 |
1; 2; 7; 7; 6; 9 | — |
| SECONDARY Simplified Disease Activity (SDAI) Response Classification |
— | — |
| SECONDARY European League Against Rheumatism (EULAR) Response |
— | — |
| SECONDARY Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6 |
38.10; 68.18; 23.81; 40.91; 14.29; 13.64 | — |
| SECONDARY Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6 |
51; -10; -20 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6 |
65; -10; -15 | — |
| SECONDARY Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI) |
6.06; 93.94; 40.00; 60.00; 26.92; 73.08 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6 |
70; -35; -30 | — |
| SECONDARY Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6 |
80; -23; -25 | — |
| SECONDARY Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6 |
60; -50; -25 | — |
| SECONDARY Percentage of Participants With an Adverse Event (AE) |
56.00 | — |
Eligibility Criteria
Inclusion Criteria
- Adult participants, >/= 18 years of age
- Moderate to severe rheumatoid arthritis
- Participants initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including participants 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
- 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 (NCT01562327). 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.