An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)
A Multi-centre Observational Study to Describe Usage and Dosification Patterns of RoActemra (Tocilizumab) Treatment in Rheumatoid Arthritis (RA) Patients in the Routine Clinical Practice. ACT-LIFE Study
1 other identifier
observational
400
2 countries
48
Brief Summary
This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2010
Typical duration for all trials
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 18, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedNovember 2, 2016
November 1, 2016
2.2 years
April 18, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons
12 months
Secondary Outcomes (7)
Safety: Incidence of adverse events
12 months
Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)
12 months
Response rate according to EULAR (European League Against Rheumatism) criteria
12 months
Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)
12 months
Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors
12 months
- +2 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra after at least one previous DMARD or TNF-inhibitor treatment
You may qualify if:
- Adult patients, \>/= 18 years of age
- Moderate to severe rheumatoid arthritis (RA) of at least 6 months duration
- Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment
- Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications
You may not qualify if:
- History of autoimmune disease or of any joint inflammatory disease other than RA
- Pregnant or lactating women
- Patients who have started RoActemra treatment in a clinical trial or for compassionate use
- Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
Unknown Facility
Coral Springs, Florida, 29010, United States
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Elche, Alicante, 03203, Spain
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Elda, Alicante, 03600, Spain
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Barcelona, Barcelona, 08036, Spain
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Barcelona, Barcelona, 08907, Spain
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Sabadell, Barcelona, 08208, Spain
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Sant Joan Despí, Barcelona, 08970, Spain
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Jerez de la Frontera, Cadiz, 11407, Spain
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Santander, Cantabria, 39008, Spain
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Torrelavega, Cantabria, 39300, Spain
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Castellon, Castellon, 12004, Spain
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Vinaròs, Castellon, 12500, Spain
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Córdoba, Cordoba, 14004, Spain
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Girona, Girona, 17002, Spain
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Granada, Granada, 18003, Spain
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Granada, Granada, 18014, Spain
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Donostia / San Sebastian, Guipuzcoa, 20080, Spain
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Huelva, Huelva, 21005, Spain
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A Coruña, La Coruña, 15006, Spain
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Santiago de Compostela, La Coruña, 15706, Spain
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Logroño, La Rioja, 26006, Spain
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Alcalá de Henares, Madrid, 28805, Spain
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Alcorcón, Madrid, 28922, Spain
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El Escorial, Madrid, 28200, Spain
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Madrid, Madrid, 28006, Spain
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Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, 28222, Spain
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Madrid, Madrid, 28905, Spain
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Madrid, Madrid, 28935, Spain
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Málaga, Malaga, 29009, Spain
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Cartagena, Murcia, 30203, Spain
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El Palmar, Murcia, 30120, Spain
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Lorca, Murcia, 30800, Spain
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Murcia, Murcia, 30008, Spain
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Pamplona, Navarre, 31008, Spain
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Ourense, Orense, 32005, Spain
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Vigo, Pontevedra, 36204, Spain
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Seville, Sevilla, 41009, Spain
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Toledo, Toledo, 45004, Spain
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Alzira, Valencia, 46600, Spain
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San Juan, Valencia, 03550, Spain
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Valencia, Valencia, 46010, Spain
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Valencia, Valencia, 46015, Spain
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Valencia, Valencia, 46017, Spain
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Valenica, Valencia, 46009, Spain
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Barakaldo, Vizcaya, 48903, Spain
Unknown Facility
Bilbao, Vizcaya, 48013, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2011
First Posted
April 19, 2011
Study Start
July 1, 2010
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11