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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01483326
First Posted: December 1, 2011
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition
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
Actual Study Start Date: December 31, 2010
Study Completion Date: June 19, 2017
Primary Completion Date: June 19, 2017 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01483326


Locations
Netherlands
Jan Van Breemen Instituut
Amsterdam, Netherlands, 1056 AB
Gelre Ziekenhuis; Reumatology
Apeldoorn, Netherlands, 7300 DS
Rijnstate Ziekenhuis; Afdeling Reumatologie
Arnhem, Netherlands, 6815 AD
Amphia ziekenhuis, locatie langendijk
Breda, Netherlands, 4819 EV
Leyenburg Ziekenhuis; Internal Medecine
Den Haag, Netherlands, 2545 CH
Deventer ziekenhuis
Deventer, Netherlands, 7416 SE
MC groep - locatie Emmeloord
Emmeloord, Netherlands, 8300 GA
Scheper Ziekenhuis
Emmen, Netherlands, 7824 AA
Medisch Centrum Twente; Rheumatology
Enschede, Netherlands, 7511 JX
Groene Hart Ziekenhuis
Gouda, Netherlands, 2803 HH
Röpcke Zweers ziekenhuis; Reumatologie
Hardenberg, Netherlands, 7772 SE
Tergooiziekenhuizen, loc. Hilversum
Hilversum, Netherlands, 1213 HX
Medisch Centrum Leeuwarden; Reumatology
Leeuwarden, Netherlands, 8934 AD
Maastricht University Medical Centre; Rheumatology
Maastricht, Netherlands, 6202 ZA
St. Antonius Ziekenhuis; Pharmacy
Nieuwegein, Netherlands, 3435 CM
St. Maartenskliniek
Nijmegen, Netherlands, 6522 JV
Maasstadziekenhuis; Reumatologie
Rotterdam, Netherlands, 3079 DZ
Vlietland Hospital
Schiedam, Netherlands, 3118 JH
Ziekenhuis Walcheren; Reumatologie
Vlissingen, Netherlands, 4382 EE
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01483326     History of Changes
Other Study ID Numbers: ML25411
First Submitted: November 23, 2011
First Posted: December 1, 2011
Last Update Posted: September 29, 2017
Last Verified: September 2017

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