Rheumatoid ArthritisNCT01667458
An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 18 sites in 2 countries.
Trial summary
This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 59 participants
- Where
- 18 sitesin 2 countries
- Study dates
- Sep 2011to Dec 2012
- 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: Patients with moderate to severe rheumatoid arthritis with an inadequate response to at least two DMARDs or an inadequate response to anti-TNF treatment, eligible for treatment with RoActemra/Actemra
Who may be able to join
- Adult patients, >/= 18 years of age
- Moderate to severe active rheumatoid arthritis, defined as DAS28 >/= 3.7
- Inadequate clinical response to current treatment with >/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-TNF therapy
- Eligible for RoActemra/Actemra treatment in daily clinical practice
- Absence of evolutive tuberculosis (TB)
Who cannot join
- Hypersensitivity to tocilizumab or any of the excipients
- Active, severe infections
- Pregnant or lactating women
- Participation in any other interventional study
- Patients with major depression
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Belgium17 sites
Study site
Aalst, 9300
Study site
Assebroek, 8310
Study site
Ath, 7800
Study site
Brussels, 1000
Study site
Dinant, 5500
Study site
Gilly (Charleroi), 6000
Study site
Kortrijk, 8500
Study site
Lier, 2500
Study site
Mons, 7000
Study site
Namur, 5000
Study site
Roeselare, 8800
Study site
Seraing, 4100
Study site
Sijsele, 8340
Study site
Turnhout, 2300
Study site
Verviers, 4800
Study site
Waremme, 4300
Study site
Westmalle, 2390
About this study
Official title: F-ACT Trial: Observational Study on Fatigue and Its Evolution During Treatment With Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis in Daily Clinical Practice
This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.
- 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.
Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16
Measured: 16 months
Secondary outcomes (7)
Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue
Measured: 16 months
Disease Activity Score DAS28
Measured: 16 months
Pain: Visual Analogue Scale VAS Pain
Measured: 16 months
Functional disability: Health Assessment Questionnaire HAQ
Measured: 16 months
Quality of sleep: VAS
Measured: 16 months
Anemia: Haemoglobin levels
Measured: 16 months
Depression: Beck Depression Inventory (BDI) questionnaire
Measured: 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startSep 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 59 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
- NCT01667458
- Sponsor's protocol ID
- ML25702
- Status last verified
- Nov 2016
- First submitted
- 15 Aug 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
Publications
Gossec L, Steinberg G, Rouanet S, Combe B. Fatigue in rheumatoid arthritis: quantitative findings on the efficacy of tocilizumab and on factors associated with fatigue. The French multicentre prospective PEPS Study. Clin Exp Rheumatol. 2015 Sep-Oct;33(5):664-70. Epub 2015 Sep 7.
PubMed 26344671
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- F-ACT Trial: Observational Study on Fatigue and Its Evolution During Treatment With Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis in Daily Clinical Practice
- ClinicalTrials.gov ID
- NCT01667458
- Acronym / sponsor ID
- ML25702
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 17 Aug 2012 (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 presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.
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
- Patients with moderate to severe rheumatoid arthritis with an inadequate response to at least two DMARDs or an inadequate response to anti-TNF treatment, eligible for treatment with RoActemra/Actemra
Key inclusion criteria (5 listed)
- Adult patients, >/= 18 years of age
- Moderate to severe active rheumatoid arthritis, defined as DAS28 >/= 3.7
- Inadequate clinical response to current treatment with >/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for >/= 3 months, or inadequate clinical response to anti-TNF therapy
- Eligible for RoActemra/Actemra treatment in daily clinical practice
- Absence of evolutive tuberculosis (TB)
Key exclusion criteria (5 listed)
- Hypersensitivity to tocilizumab or any of the excipients
- Active, severe infections
- Pregnant or lactating women
- Participation in any other interventional study
- Patients with major depression
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
Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16
Time frame: 16 months
7 secondary outcomes
Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue
Time frame: 16 months
Disease Activity Score DAS28
Time frame: 16 months
Pain: Visual Analogue Scale VAS Pain
Time frame: 16 months
Functional disability: Health Assessment Questionnaire HAQ
Time frame: 16 months
Quality of sleep: VAS
Time frame: 16 months
Anemia: Haemoglobin levels
Time frame: 16 months
Depression: Beck Depression Inventory (BDI) questionnaire
Time frame: 16 months
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 2 Nov 2016.
- Derived from this study: PubMed 26344671Gossec L, Steinberg G, Rouanet S, Combe B. Fatigue in rheumatoid arthritis: quantitative findings on the efficacy of tocilizumab and on factors associated with fatigue. The French multicentre prospective PEPS Study. Clin Exp Rheumatol. 2015 Sep-Oct;33(5):664-70. Epub 2015 Sep 7.
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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
18 sites in 2 countries: 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 18 sites in 2 countries.
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 5 inclusion and 5 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 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Belgium, Luxembourg. 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?
Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16 (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01667458, which also lists 1 linked publication.
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 2 Nov 2016.