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

NCT ID: NCT01338545

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Coral Springs, Florida, United States

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Elche, Alicante, Spain

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Elda, Alicante, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Sant Joan Despí, Barcelona, Spain

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Jerez de la Frontera, Cadiz, Spain

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Santander, Cantabria, Spain

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Torrelavega, Cantabria, Spain

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Castellon, Castellon, Spain

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Vinaròs, Castellon, Spain

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Córdoba, Cordoba, Spain

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Girona, Girona, Spain

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Granada, Granada, Spain

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Granada, Granada, Spain

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Donostia / San Sebastian, Guipuzcoa, Spain

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Huelva, Huelva, Spain

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A Coruña, La Coruña, Spain

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Santiago de Compostela, La Coruña, Spain

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Logroño, La Rioja, Spain

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Alcalá de Henares, Madrid, Spain

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Alcorcón, Madrid, Spain

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El Escorial, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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Cartagena, Murcia, Spain

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El Palmar, Murcia, Spain

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Lorca, Murcia, Spain

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Murcia, Murcia, Spain

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Pamplona, Navarre, Spain

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Ourense, Orense, Spain

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Vigo, Pontevedra, Spain

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Seville, Sevilla, Spain

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Toledo, Toledo, Spain

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Alzira, Valencia, Spain

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San Juan, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valenica, Valencia, Spain

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Barakaldo, Vizcaya, Spain

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Bilbao, Vizcaya, Spain

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Countries

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United States Spain

Other Identifiers

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ML25264

Identifier Type: -

Identifier Source: org_study_id