N/A
Completed N=107
An Observational Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT01669902 ↗Enrolled (actual)
107
Serious AEs
9.4%
Results posted
Nov 2015
Primary outcomePrimary: Percentage of Participants on Tocilizumab Treatment at Month 6 — 76.6 percentage of participants
Summary
This multicenter observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with active moderate to severe rheumatoid arthritis unable to use methotrexate. Eligible patients initiated on RoActemra/Actemra treatment will be followed for 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on Tocilizumab Treatment at Month 6 |
76.6 | — |
| SECONDARY Percentage of Participants With Dose Modifications of Tocilizumab |
36.4 | — |
| SECONDARY Swollen Joint Count (SJC) |
5.6; 2.5; 1.8 | — |
| SECONDARY Tender Joint Count (TJC) |
8.6; 4.5; 3.7 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) |
4.76; 3.17; 2.98 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (CRP) |
36.2; 40.0 | — |
| SECONDARY Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) |
5.03; 2.98; 2.64 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission Based on DAS28-4 (ESR) |
38.8; 57.8 | — |
| SECONDARY Percentage of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28-4 (CRP) |
43.5; 33.3; 23.2; 43.3; 33.3; 23.3 | — |
| SECONDARY Percentage of Participants With EULAR Response Based on DAS28-4 (ESR) |
51.0; 34.7; 14.3; 55.6; 31.1; 13.3 | — |
| SECONDARY Simplified Disease Activity Index (SDAI) |
22.46; 11.48; 10.73 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission Based on SDAI |
12.9; 16.7 | — |
| SECONDARY Clinical Disease Activity Index (CDAI) |
21.3; 10.9; 10.4 | — |
| SECONDARY Percentage of Participants Achieving Clinical Remission Based on CDAI |
12.1; 16.7 | — |
| SECONDARY Number of Participants With an American College of Rheumatology (ACR) Response |
— | — |
| SECONDARY Patient Global Assessment (PtGA) of Disease Activity Score |
61.6; 41.3; 41.6 | — |
| SECONDARY Physician Global Assessment (PGA) of Disease Activity |
34.0; 19.1; 15.2 | — |
| SECONDARY Percentage of Participants in a PGA of Disease Activity Score Category |
2.0; 56.9; 33.3; 7.8; 8.7; 52.2 | — |
| SECONDARY Patient Global Assessment of Pain |
60.5; 38.4; 39.9 | — |
| SECONDARY Percentage of Participants With Morning Stiffness |
55.1; 9.0; 36.0; 47.5; 3.8; 48.8 | — |
| SECONDARY Percentage of Participants With Duration of Morning Stiffness |
10.2; 24.5; 32.7; 20.4; 6.1; 6.1 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Months 3 and 6 |
1.29; -0.29; -0.21 | <0.0001 sig |
| SECONDARY Percentage of Participants With Concomitant Corticosteroids Treatment |
26.2 | — |
| SECONDARY Number of Participants With Use of Disease-Modifying Anti-Rheumatic Drugs (DMARDs) During the Study |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
- Patients who for any reason do not take methotrexate and for whom the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy; patients who commenced RoActemra/Actemra as monotherapy within 8 weeks prior to the enrolment visit may be included
- Concomitant treatment with non-steroidal anti-inflammatory drug (NSAID) or corticosteroids (orally or intra-articularly) is allowed
Exclusion Criteria
- Patients who have received RoActemra/Actemra more than 8 weeks prior to enrolment visit
- Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
- Concomitant DMARD treatment for rheumatoid arthritis (e.g. hyroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting RoActemra/Actemra treatment
- History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01669902). 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.