N/A
Completed N=136
A Study to Evaluate Tocilizumab Treatment in a Real-Life Setting
Source: ClinicalTrials.gov NCT01664104 ↗Enrolled (actual)
136
Serious AEs
1.5%
Results posted
Jul 2017
Primary outcomePrimary: Percentage of Participants on TCZ Treatment at Month 6 — 86.5 percentage of participants
Summary
This observational, multi-center study will evaluate the treatment regimen, treatment responses and safety of tocilizumab therapy in a routine clinical practice in participants with moderate to severe rheumatoid arthritis (RA). Data will be collected for 6 months with a maximum study duration of 18 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants on TCZ Treatment at Month 6 |
86.5 | — |
| SECONDARY Percentage of Participants by TCZ Dose at Month 6 |
93.91; 1.74; 0.87; 0.87; 0.87; 0.87 | — |
| SECONDARY Percentage of Participants Starting TCZ After Inadequate Response (IR) to a Biologic Treatment or After Intolerance or IR to Disease-Modifying Anti-Rheumatic Drugs (DMARDs) |
62.4; 37.6 | — |
| SECONDARY Time Elapsed From Diagnosis of RA |
6.5 | — |
| SECONDARY Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline |
61.3 | — |
| SECONDARY Patient Global Assessment of Disease Activity (PGH) Using VAS at Baseline |
61.0 | — |
| SECONDARY Physician Global Assessment of Disease Activity (PhGH) Using VAS at Baseline |
53.4 | — |
| SECONDARY Participant Assessment of Morning Stiffness Using VAS at Baseline |
47.0 | — |
| SECONDARY Participant Assessment of Fatigue Using VAS at Baseline |
57.1 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Baseline |
1.4 | — |
| SECONDARY Tender Joint Count (TJC) at Baseline |
11.5 | — |
| SECONDARY Swollen Joint Count (SJC) at Baseline |
6.7 | — |
| SECONDARY Erythrocyte Sedimentation Rate (ESR) at Baseline |
33.0 | — |
| SECONDARY C-Reactive Protein (CRP) at Baseline |
2.7 | — |
| SECONDARY Percentage of Participants With Presence of Extra-Articular Systemic Features of RA at Baseline |
7.0 | — |
| SECONDARY Percentage of Participants With Evidence of Structural Joint Damage at Baseline |
71.9 | — |
| SECONDARY Percentage of Participants With Previous RA-Related Surgical Procedures at Baseline |
12.9 | — |
| SECONDARY Percentage of Participants With Positive Rheumatoid Factor (RF) at Baseline |
59.5 | — |
| SECONDARY Percentage of Participants With Anti-Citrullinated Cyclic Peptide at Baseline |
58.3 | — |
| SECONDARY Percentage of Participants by Duration of Morning Stiffness at Baseline |
6.8; 15.0; 30.1; 25.6; 4.5; 3.8 | — |
| SECONDARY Number of Participants With TCZ Dose Change According to the Reason for Change |
3; 1; 1; 1 | — |
| SECONDARY Percentage of Participants by Number of TCZ Dose Modifications Per Participant |
95.49; 1.50; 3.01 | — |
| SECONDARY Time in Days Elapsed Between TCZ Infusions |
31; 31.5; 31; 30; 31; 29 | — |
| SECONDARY Percentage of Participants With TCZ Infusion Interruption |
3.01; 96.99 | — |
| SECONDARY Percentage of Participants Who Discontinued TCZ by Reason for Discontinuation |
50.0; 33.33; 16.67 | — |
| SECONDARY Percentage of Participants With TCZ Reintroduction |
1.5; 98.5 | — |
| SECONDARY Percentage of Participants by Reason for Choice of TCZ Monotherapy at Baseline |
12.5; 85; 2.5 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) Score at Month 3 and Month 6 |
5.16; 1.99; 2.15 | <0.0001 sig |
| SECONDARY Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 3 and Month 6 |
35.12; 19.37; 20.35 | <0.0001 sig |
| SECONDARY Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 3 and Month 6 |
30.48; 15.06; 15.96 | <0.0001 sig |
| SECONDARY Percentage of Participants by DAS28 Class at the Start of TCZ Treatment and After Month 3 and Month 6 |
3.5; 1.8; 43.9; 50.9; 30.4; 14.1 | — |
| SECONDARY Percentage of Participants by SDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6 |
2.2; 7.5; 36.6; 63.4; 7.2; 34.9 | — |
| SECONDARY Percentage of Participants by CDAI Class at the Start of TCZ Treatment and After Month 3 and Month 6 |
2.1; 8.2; 24.7; 75.3; 7.4; 36.2 | — |
| SECONDARY Percentage of Participants With an American College of Rheumatology (ACR) 20%, 50%, 70%, or 90% (ACR20/50/70/90) Response After Month 3 and Month 6 From the Start of TCZ Treatment |
45; 38.3; 16.7; 23.3; 62.5; 14.2 | — |
| SECONDARY Change From Baseline to Month 6 in TJC |
6.0 | — |
| SECONDARY Change From Baseline to Month 6 in SJC |
4.2 | — |
| SECONDARY Change From Baseline to Month 6 in PGH |
21.4 | — |
| SECONDARY Change From Baseline to Month 6 in PhGH |
23.9 | — |
| SECONDARY Change From Baseline to Month 6 in Patient's Assessment of Pain |
22.5 | — |
| SECONDARY Change From Baseline to Month 6 in HAQ-DI Score |
0.4 | — |
| SECONDARY Change From Baseline to Month 6 in Participant Assessment of Fatigue |
17.9 | — |
| SECONDARY Change From Baseline to Month 6 in Participant Assessment of Morning Stiffness |
18.8 | — |
| SECONDARY Percentage of Participants With Clinically Meaningful Improvement in HAQ-DI |
36.7; 45.8 | — |
| SECONDARY Percentage of Participants Achieving Good/Moderate/No European League Against Rheumatism (EULAR) Response at Month 3 and Month 6 |
41.3; 47.8; 10.9; 45.5; 40.9; 13.6 | — |
| SECONDARY Time to DMARD Dose Reduction |
3.2 | — |
| SECONDARY Time to DMARD Dose Withdrawal |
4.1 | — |
| SECONDARY Percentage of Participants by Reason for DMARD Withdrawal During the Study |
18.18; 9.09; 36.36; 36.36 | — |
| SECONDARY Time to Steroid Dose Reduction |
2.3 | — |
| SECONDARY Time to Steroid Dose Withdrawal |
1.8 | — |
| SECONDARY Change From Baseline in CRP at Month 3 and Month 6 |
2.28; 1.98 | <0.0001 sig |
| SECONDARY Change From Baseline in ESR at Month 3 and Month 6 |
23.15; 21.42 | <0.0001 sig |
| SECONDARY CRP at the Start of TCZ Treatment by Remission Status Using DAS28-CRP, SDAI, and CDAI at Month 6 |
2.2; 3.1; 4.6; 2.8; 4.2; 2.7 | 0.6904 |
| SECONDARY Body Mass Index (BMI) at the Start of TCZ Treatment by Remission Status Using DAS-28 CRP, SDAI, and CDAI at Month 6 |
23.3; 26.7; 23.7; 26.0; 23.8; 26.6 | 0.0018 sig |
| SECONDARY Percentage of Participants With and Without Morning Stiffness |
70.0; 15.8; 10.8; 3.3; 65.0; 25.8 | — |
| SECONDARY Percentage of Participants by Duration of Morning Stiffness |
15.8; 25.8; 40.8; 35.0; 20.0; 21.7 | — |
| SECONDARY CRP at the Start of TCZ Treatment by Morning Stiffness at Month 6 |
3.3; 2.1 | 0.5332 |
| SECONDARY BMI at the Start of TCZ Treatment by Morning Stiffness at Month 6 |
26.1; 26.6 | 0.6159 |
| SECONDARY Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6 |
0.12663; 0.02678 | 0.2370 |
| SECONDARY Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and HAQ-DI (0-3) at Month 6 |
0.25513; 0.21125 | 0.0306 sig |
| SECONDARY Correlation Coefficient Between CRP (mg/dL) at the Start of TCZ Treatment and VAS Fatigue at Month 6 |
0.08180; -0.11521 | 0.4854 |
| SECONDARY Correlation Coefficient Between Change From Baseline in CRP (mg/dL) at the Start of TCZ Treatment and Change From Baseline in VAS Fatigue at Month 6 |
0.41350; 0.40842 | 0.0011 sig |
| SECONDARY Correlation Coefficient Between BMI at the Start of TCZ Treatment and HAQ-DI (0-3) at Month 6 |
0.08505; 0.12488 | 0.5655 |
| SECONDARY Correlation Coefficient Between Change From Baseline in CRP (mg/dL) and Change From Baseline in Morning Stiffness According to VAS at Month 6 |
0.41875; 0.40754 | 0.0123 sig |
| SECONDARY Correlation Coefficient Between BMI at the Start of TCZ Treatment and VAS Fatigue at Month 6 |
0.00181; -0.07250 | 0.9909 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of moderate to severe RA according to revised American College of Rheumatology criteria
- Participants have started tocilizumab treatment according to routine clinical practice within 3 months prior to site opening and still in treatment, as well as participants who began treatment at enrollment
Exclusion Criteria
- Participants who have started tocilizumab treatment more than 3 months prior to site opening
- Participants who have previously received tocilizumab in a clinical trial setting or for compassionate use
- Participants who have been enrolled in an ongoing clinical trial and/or have received treatment with any investigational drug within 4 weeks prior to study start
- Participants with a history of autoimmune disease or joint inflammatory disease other than RA
Data sourced from ClinicalTrials.gov (NCT01664104). 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.