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.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483326
First received: November 23, 2011
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

This observational study will evaluate the long-term efficacy and safety of RoAc temra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and fu rther patients with moderate to severe rheumatoid arthritis starting or receivin g 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in disability, assessed by Health Assessment Questionnaire (HAQ) [ Time Frame: baseline and up to 4 years ] [ Designated as safety issue: No ]
  • Change in concomitant medication (especially tapering of steroids) [ Time Frame: baseline and up to 4 years ] [ Designated as safety issue: No ]
  • Change in dosage schedule (modification/interruption/discontinuation) [ Time Frame: baseline and up to 4 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: August 2009
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: February 2017 (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

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
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: NCT01483326

Locations
Netherlands
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01483326     History of Changes
Other Study ID Numbers: ML25411
Study First Received: November 23, 2011
Last Updated: August 4, 2014
Health Authority: Netherlands: Medicines Evaluation Board

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