An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)

Completed

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01338545

Run by

Hoffmann-La Roche

People needed

400

Starts

2010-07-01

Expected to finish

2012-09-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• Study site — Coral Springs, Florida, United States
• Study site — Elche, Alicante, Spain
• Study site — Elda, Alicante, Spain
• Study site — Barcelona, Barcelona, Spain
• Study site — Barcelona, Barcelona, Spain
• Study site — Sabadell, Barcelona, Spain
• Study site — Sant Joan Despí, Barcelona, Spain
• Study site — Jerez de la Frontera, Cadiz, Spain
• Study site — Santander, Cantabria, Spain
• Study site — Torrelavega, Cantabria, Spain
• Study site — Castellon, Castellon, Spain
• Study site — Vinaròs, Castellon, Spain
• Study site — Córdoba, Cordoba, Spain
• Study site — Girona, Girona, Spain
• Study site — Granada, Granada, Spain
• Study site — Granada, Granada, Spain
• Study site — Donostia / San Sebastian, Guipuzcoa, Spain
• Study site — Huelva, Huelva, Spain
• Study site — A Coruña, La Coruña, Spain
• Study site — Santiago de Compostela, La Coruña, Spain
• Study site — Logroño, La Rioja, Spain
• Study site — Alcalá de Henares, Madrid, Spain
• Study site — Alcorcón, Madrid, Spain
• Study site — El Escorial, Madrid, Spain
• Study site — Madrid, Madrid, Spain

Full record on ClinicalTrials.gov

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