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NCT Number: NCT01338545

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Elche, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons

    Time frame: 12 months

Secondary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 12 months

  2. Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)

    Time frame: 12 months

  3. Response rate according to EULAR (European League Against Rheumatism) criteria

    Time frame: 12 months

  4. Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)

    Time frame: 12 months

  5. Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors

    Time frame: 12 months

  6. Effect on DMARD tolerance/dosage in combination therapy

    Time frame: 12 months

  7. Dosages used in clinical practice

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 19, 2011
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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