Rheumatoid ArthritisNCT01483326
An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 19 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 215 participants
- Where
- 19 sitesNetherlands
- Study dates
- 31 Dec 2010to 19 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the ACT SURE clinical trial or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra
Who may be able to join
- 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
Who cannot join
- Contra-indications for RoActemra/Actemra
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Netherlands19 sites
Jan Van Breemen Instituut
Amsterdam, 1056 AB
Gelre Ziekenhuis; Reumatology
Apeldoorn, 7300 DS
Rijnstate Ziekenhuis; Afdeling Reumatologie
Arnhem, 6815 AD
Amphia ziekenhuis, locatie langendijk
Breda, 4819 EV
Deventer ziekenhuis
Deventer, 7416 SE
MC groep - locatie Emmeloord
Emmeloord, 8300 GA
Scheper Ziekenhuis
Emmen, 7824 AA
Medisch Centrum Twente; Rheumatology
Enschede, 7511 JX
Ziekenhuis Walcheren; Reumatologie
Flushing, 4382 EE
Groene Hart Ziekenhuis
Gouda, 2803 HH
Röpcke Zweers ziekenhuis; Reumatologie
Hardenberg, 7772 SE
Tergooiziekenhuizen, loc. Hilversum
Hilversum, 1213 HX
Medisch Centrum Leeuwarden; Reumatology
Leeuwarden, 8934 AD
Maastricht University Medical Centre; Rheumatology
Maastricht, 6202 ZA
St. Antonius Ziekenhuis; Pharmacy
Nieuwegein, 3435 CM
St. Maartenskliniek
Nijmegen, 6522 JV
Maasstadziekenhuis; Reumatologie
Rotterdam, 3079 DZ
Vlietland Hospital
Schiedam, 3118 JH
Leyenburg Ziekenhuis; Internal Medecine
The Hague, 2545 CH
About this study
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
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.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in disease activity score (DAS 28)
Measured: baseline and up to 4 years
Secondary outcomes (5)
Change in disability, assessed by Health Assessment Questionnaire (HAQ)
Measured: baseline and up to 4 years
Change in concomitant medication (especially tapering of steroids)
Measured: baseline and up to 4 years
Change in dosage schedule (modification/interruption/discontinuation)
Measured: baseline and up to 4 years
Safety: Incidence of adverse events
Measured: 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)
Measured: up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study start31 Dec 2010
- Primary completion19 Jun 2017
- Study completion19 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01483326
- Sponsor's protocol ID
- ML25411
- Status last verified
- Apr 2019
- First submitted
- 23 Nov 2011
- Last updated
- 1 May 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01483326
- Acronym / sponsor ID
- ML25411
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2010 (actual)
- Primary completion
- 19 Jun 2017 (actual)
- Study completion
- 19 Jun 2017 (actual)
- First posted
- 1 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the ACT SURE clinical trial or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Contra-indications for RoActemra/Actemra
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in disease activity score (DAS 28)
Time frame: baseline and up to 4 years
5 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 19 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in disease activity score (DAS 28) (time frame: baseline and up to 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2019.