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 currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01483326
First received: November 23, 2011
Last updated: May 7, 2013
Last verified: May 2013
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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 ] [ 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 ]
| Estimated Enrollment: | 250 |
| Study Start Date: | August 2009 |
| Estimated Study Completion Date: | July 2018 |
| Estimated Primary Completion Date: | July 2018 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01483326
Contacts
| Contact: Please reference Study ID Number: ML25411 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Netherlands | |
| Recruiting | |
| Amsterdam, Netherlands, 1056 AB | |
| Recruiting | |
| Apeldoorn, Netherlands, 7300 DS | |
| Recruiting | |
| Arnhem, Netherlands, 6815 AD | |
| Recruiting | |
| Breda, Netherlands, 4819 EV | |
| Recruiting | |
| Den Haag, Netherlands, 2545 CH | |
| Recruiting | |
| Deventer, Netherlands, 7416 SE | |
| Recruiting | |
| Deventer, Netherlands, 7415 CM | |
| Recruiting | |
| Emmeloord, Netherlands, 8300 GA | |
| Recruiting | |
| Emmen, Netherlands, 7824 AA | |
| Recruiting | |
| Enschede, Netherlands, 7511 JX | |
| Recruiting | |
| Gouda, Netherlands, 2803 HH | |
| Recruiting | |
| Hardenberg, Netherlands, 7772 SE | |
| Recruiting | |
| Hilversum, Netherlands, 1213 HX | |
| Recruiting | |
| Leeuwarden, Netherlands, 8934 AD | |
| Recruiting | |
| Maastricht, Netherlands, 6202 ZA | |
| Recruiting | |
| Nieuwegein, Netherlands, 3435 CM | |
| Recruiting | |
| Nijmegen, Netherlands, 6522 JV | |
| Recruiting | |
| Schiedam, Netherlands, 3118 JH | |
| Recruiting | |
| 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: | May 7, 2013 |
| 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 May 16, 2013