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An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 23, 2011
Last updated: November 1, 2016
Last verified: November 2016
This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: FAct: A Non-interventional Multi-center Study to Follow Patients Starting With RoActemra Assessing the Long Term Efficacy, Effectiveness and Safety of RoActemra

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in disease activity score (DAS 28) [ Time Frame: baseline and up to 4 years ]

Secondary Outcome Measures:
  • Change in disability, assessed by Health Assessment Questionnaire (HAQ) [ Time Frame: baseline and up to 4 years ]
  • Change in concomitant medication (especially tapering of steroids) [ Time Frame: baseline and up to 4 years ]
  • Change in dosage schedule (modification/interruption/discontinuation) [ Time Frame: baseline and up to 4 years ]
  • Safety: Incidence of adverse events [ Time Frame: up to 4 years ]
  • Response (DAS 28) according to patient-related factors (C-reactive protein, rheumatoid factor, inadequate response to anti-TNF/DMARDs, duration of illness) [ Time Frame: up to 4 years ]

Enrollment: 215
Study Start Date: December 2010
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants in the ACT SURE clinical trial or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra

Inclusion Criteria:

  • Adult patients, >18 years of age
  • Participants in the ACT-SURE trial, or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra

Exclusion Criteria:

  • Contra-indications for RoActemra/Actemra
  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 identifier: NCT01483326

Amsterdam, Netherlands, 1056 AB
Apeldoorn, Netherlands, 7300 DS
Arnhem, Netherlands, 6815 AD
Breda, Netherlands, 4819 EV
Den Haag, Netherlands, 2545 CH
Deventer, Netherlands, 7416 SE
Emmeloord, Netherlands, 8300 GA
Emmen, Netherlands, 7824 AA
Enschede, Netherlands, 7511 JX
Gouda, Netherlands, 2803 HH
Hardenberg, Netherlands, 7772 SE
Hilversum, Netherlands, 1213 HX
Leeuwarden, Netherlands, 8934 AD
Maastricht, Netherlands, 6202 ZA
Nieuwegein, Netherlands, 3435 CM
Nijmegen, Netherlands, 6522 JV
Rotterdam, Netherlands, 3079 DZ
Schiedam, Netherlands, 3118 JH
Vlissingen, Netherlands, 4382 EE
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01483326     History of Changes
Other Study ID Numbers: ML25411
Study First Received: November 23, 2011
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 28, 2017