Text Size

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01338545
First received: April 18, 2011
Last updated: June 3, 2013
Last verified: June 2013
History of Changes
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety: Incidence of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Response rate according to EULAR (European League Against Rheumatism) criteria [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Quality of life (Visual Analogue Scales, Health Assessment Questionnaire) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Effect on DMARD tolerance/dosage in combination therapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Dosages used in clinical practice [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: July 2010
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra after at least one previous DMARD or TNF-inhibitor treatment

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338545

  Show 48 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01338545     History of Changes
Other Study ID Numbers: ML25264
Study First Received: April 18, 2011
Last Updated: June 3, 2013
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013