N/A
N=693
An Observational Study of the Impact of RoActemra/Actemra on Fatigue in Patients With Rheumatoid Arthritis (PEPS)
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01185522 ↗Enrolled (actual)
693
Serious AEs
3.9%
Results posted
Jun 2016
Primary outcome: Primary: Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment — 63.3 Percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment |
63.3 | — |
| PRIMARY Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors |
214; 46; 4; 139; 125; 108 | 0.235 |
| PRIMARY Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment |
13.0 | 0.004 sig |
| PRIMARY Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment |
10.02; 7.28 | 0.253 |
| SECONDARY Baseline Disease Characteristics: Mean Disease Duration |
11.7 | — |
| SECONDARY Baseline Disease Characteristics: Number of Participants With Positive Rheumatoid Factor and/or Anti-cyclic Citrullinated Protein Antibodies |
463 | — |
| SECONDARY Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count |
9.9; 6.6 | — |
| SECONDARY Baseline Disease Characteristic: DAS28, Patient's Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters |
5.3; 63.9; 62.7; 1.6 | — |
| SECONDARY Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue |
307; 278; 148; 423 | — |
| SECONDARY Baseline Disease Characteristic: Mean FACIT-Fatigue Score and VAS Fatigue Score |
24.4; 61.3 | — |
| SECONDARY Correlation Between Relative Changes From Baseline of FACIT-Fatigue Score and VAS Fatigue to 4 Months of Tocilizumab Treatment |
-0.1736 | — |
| SECONDARY Median Time to Onset of an Improvement of the FACIT-Fatigue Score |
1.0 | — |
| SECONDARY Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4 |
-30.9; -40.5; -46.1; -48.4; -21.7; -34.8 | — |
| SECONDARY Relative Median Change From Baseline in Disease Activity (Tender Joint Count and Swollen Joint Count) to Month 1, Month 2, Month 3, and Month 4 |
-34.3; -55.3; -66.7; -67.3; -42.9; -60.0 | — |
| SECONDARY Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4 |
-70.0; -75.0; -78.1; -78.6 | — |
| SECONDARY Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4 |
-76.6; -80.0; -80.4; -81.3 | — |
| SECONDARY Number of Participants Achieving PASS Score at Baseline (Day 0) and Month 4 |
155; 269 | — |
| SECONDARY Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4 |
39.0; 45.0; 55.0; 60.0; 61.0; 47.0 | — |
| SECONDARY Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4 |
-0.4843; -0.0656; -0.4785; -0.1339; 0.7536; 0.6720 | — |
| SECONDARY Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4 |
558; 540; 511; 477; 472; 463 | — |
| SECONDARY Number of Participants With Any Adverse Events and Serious Adverse Events |
272; 27 | — |
Summary
This prospective, observational study will assess the effect of RoActemra/Actemra (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti tumor necrosis factor (anti-TNF) drugs. Eligible patients receiving RoActemra/Actemra according to the standard of care will be followed for 4 months.
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/= 18 years of age
- Moderate to severe rheumatoid arthritis
- Inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti-TNF (tumor necrosis factor) drugs
Exclusion Criteria
- Hypersensitivity to RoActemra/Actemra or any component
- Active infection
- Participation in a clinical trial in rheumatoid arthritis
Data sourced from ClinicalTrials.gov (NCT01185522). 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.