Clinical trial NCT01462162: A Prospective Observational Study of Tocilizumab (RoActemra/Actemra) in Participants With Rheumatoid Arthritis
Official title: A Prospective Observational Study to Evaluate and Correlate the Impact of Treatment With Tocilizumab (RoActemra®) on Fatigue and Different Factors Influencing Fatigue in Participants With Rheumatoid Arthritis in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-31
Enrollment: 122
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 Rheumatoid Arthritis

Brief summary: This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 months.


Eligibility criteria: Inclusion Criteria:

* Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab according to his/her clinical judgment and the conditions approved in the Summary of Product Characteristics (SPC).

Exclusion Criteria:

* Participants previously or currently treated with RoActemra/Actemra in clinical trials
* Absolute neutrophil count less than or equal to (\</=) 2x10\^9 per liter (/L)

Primary outcomes:
measure: Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12
timeFrame: Week 12
measure: Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F
timeFrame: Baseline, Week 12, Week 24
measure: Change From Baseline to Week 12 and 24 in Serum Hemoglobin
timeFrame: Baseline, Week 12, 24
measure: Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24
timeFrame: Week 12, 24
measure: Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24
timeFrame: Week 12, 24
measure: Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population
timeFrame: Week 12, 24
measure: Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in the Number of Swollen Joints (SJC 28) at Week 12 and 24 - Safety Population
timeFrame: Week 12, 24
measure: Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24
timeFrame: Baseline, Week 12, Week 24
measure: Change From Baseline in Number of Swollen Joint Count (SJC) at Week 12, 24 - Safety Population
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Duration of Morning Stiffness at Week 12, 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Duration of Morning Stiffness at Week 12, 24 - Safety Population
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Pain Scores as Assessed by Visual Analogue Scale (VAS) at Week 12, 24 - Safety Population
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Sleepiness Score as Assessed on Epworth Sleepiness Scale at Week 12, 24 - Safety Population
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Depression Score as Assessed by the Beck Depression Inventory at Week 12, 24 - Safety Population
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24
timeFrame: Baseline, Week 12, 24
measure: Change From Baseline in Disease Activity Scale (DAS28) Score at Week 12, 24 - Safety Population
timeFrame: Baseline, Week 12, 24
measure: Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24
timeFrame: Week 12, 24
measure: Percentage of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria at Week 12 and 24 - Safety Population
timeFrame: Week 12, 24
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
state: Barcelona
city: Mollet del Valles
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Sant Joan Despi
country: Spain
state: Barcelona
city: A Coruña
country: Spain
state: La Coruña
city: Cartagena
country: Spain
state: Murcia
city: El Palmar
country: Spain
state: Murcia
city: Lorca
country: Spain
state: Murcia
city: Ourense
country: Spain
state: Orense
city: Vigo
country: Spain
state: Pontevedra
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Girona
country: Spain
city: Lugo
country: Spain
city: Tarragona
country: Spain
city: Tarragona
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: