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: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderat e to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data wi ll 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:


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: September 2012
Primary Completion Date: September 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: August 4, 2014
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 August 26, 2014