Clinical trial NCT01185522: An Observational Study of the Impact of RoActemra/Actemra on Fatigue in Patients With Rheumatoid Arthritis (PEPS)
Official title: Pharmacoepidemiological Study of the Impact of Roactemra® Treatment on Fatigue in Rheumatoid Arthritis Patients in a Real Life Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-08-20
Enrollment: 719
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with inadequate response to DMARDs or anti-TNF receiving RoActemra/Actemra according to standard of care

Brief 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

Primary outcomes:
measure: Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment
timeFrame: At Month 4
measure: Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors
timeFrame: At Month 4
measure: Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment
timeFrame: At Month 4
measure: Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment
timeFrame: At Month 4
Secondary outcomes:
measure: Baseline Disease Characteristics: Mean Disease Duration
timeFrame: Baseline (Day [D] 0)
measure: Baseline Disease Characteristics: Number of Participants With Positive Rheumatoid Factor and/or Anti-cyclic Citrullinated Protein Antibodies
timeFrame: Baseline (D0)
measure: Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count
timeFrame: Baseline (D0)
measure: Baseline Disease Characteristic: DAS28, Patient's Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters
timeFrame: Baseline (D0)
measure: Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue
timeFrame: Baseline (D0)
measure: Baseline Disease Characteristic: Mean FACIT-Fatigue Score and VAS Fatigue Score
timeFrame: Baseline (D0)
measure: Correlation Between Relative Changes From Baseline of FACIT-Fatigue Score and VAS Fatigue to 4 Months of Tocilizumab Treatment
timeFrame: From Baseline (D0) to Month (M) 4
measure: Median Time to Onset of an Improvement of the FACIT-Fatigue Score
timeFrame: Up to Month 4
measure: Relative Median Change From Baseline in DAS 28 and VAS Patient's Global Assessment to Month 1, Month 2, Month 3, and Month 4
timeFrame: From Baseline (D0) to M 1, M 2, M 3, and M 4
measure: 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
timeFrame: From Baseline (D0) to M 1, M 2, M 3, and M 4
measure: Relative Median Change From Baseline in ESR to Month 1, Month 2, Month 3, and Month 4
timeFrame: From Baseline (D0) to M 1, M 2, M 3, and M 4
measure: Relative Median Change From Baseline in C - Reacting Protein at Month 1, Month 2, Month 3, and Month 4
timeFrame: From Baseline (D0) to M 1, M 2, M 3, and M 4
measure: Number of Participants Achieving PASS Score at Baseline (Day 0) and Month 4
timeFrame: Baseline (D0) and Month 4
measure: Percentage of Participants With FACIT-Fatigue Score, SF36 Vitality Score, and VAS Fatigue at Day 0 and Month 4
timeFrame: Baseline (D0) and Month 4
measure: Correlations Between Fatigue and Other Participant Reported Outcomes at Day 0 and Month 4
timeFrame: Day 0 and Month 4
measure: Number of Participants for Rheumatoid Arthritis Management With Tocilizumab Treatment up to Month 4
timeFrame: From Baseline (D0) to M 1, M 2, M 3, and M 4
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Neuilly-sur-seine
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: