Rheumatoid ArthritisNCT00938444
Evaluation of the BRADA and ABILHAND Questionnaires
An observational study of Rheumatoid Arthritis, run by University Hospital, Ghent at 19 sites in Belgium.
Trial summary
This protocol is designed to evaluate the BRADA and ABILHAND questionnaires in rheumatoid arthritis (RA) patients that will be treated with an effective therapy. Patients with moderate to severe RA treated with tocilizumab will be asked to complete the BRADA and ABILHAND questionnaires at screening, baseline, after 12… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 80 participants
- Where
- 19 sitesBelgium
- Study dates
- Jun 2009to Dec 2010
- 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 RA.
Who may be able to join
- patients with moderate to severe RA.
- Inadequate response on earlier optimal use of a minimum of two DMARDs (disease modifying anti-rheumatic drugs such as goldsalts, salazopyrine, leflunomide, methotrexate (MTX)) as far as one of the two used DMARDs is MTX that at the exception of a documented intolerance despite the association with folic acid, should have been administered IM or oral during a minimum of 3 months and at a minimal dose of 15mg/week.
- DAS 28 score ≥ 5.1
- For whom a drug that is registered for the treatment of moderate to severe RA is commercially available but does not constitute a satisfactory treatment for this patient.
Who cannot join
None listed.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Belgium19 sites
ASZ
Aalst, 9300
Clinique St. Luc
Bouge, 5004
CHU Brugmann
Brussels, 1020
UCL St. Luc
Brussels, 1200
UZA
Edegem, 2650
AZ Sint-Lucas
Ghent, 9000
University Hospital Ghent
Ghent, 9000
Reuma Instituut
Hasselt, 3500
AZ Groeninge
Kortrijk, 8500
UZ Gasthuisberg
Leuven, 3000
CHU de Liège
Liège, 4000
Jan Palfijn
Merksem, Antwerpen, 2170
CH Notre Dame - R Fabiola
Montignies-sur-Sambre, 6061
Clinique St. Pierre
Ottignies, 1340
Clinique St. Vincent
Rocourt, 4000
Heilig Hartziekenhuis
Roeselare, 8800
AZ Alma
Sijsele, 8340
Hôpital de Jolimont
Soignies, 7060
UCL Mont-Godinne
Yvoir, 5530
About this study
Official title: Prospective, Multicenter, Non-interventional Study in RA Patients Treated With Tocilizumab - Evaluation of the BRADA and ABILHAND Questionnaires
This protocol is designed to evaluate the BRADA and ABILHAND questionnaires in rheumatoid arthritis (RA) patients that will be treated with an effective therapy. Patients with moderate to severe RA treated with tocilizumab will be asked to complete the BRADA and ABILHAND questionnaires at screening, baseline, after 12 weeks and after 24 weeks of treatment. All other assessments and questionnaires from daily clinical practice (such as the global assessment of disease activity by the patient, the Health Assessment Questionnaire (HAQ), the SF36 questionnaire, measurement of ESR and CRP and the DAS 28 calculation), will also be used to evaluate these questionnaires.
- Conditions
- Rheumatoid Arthritis
- Keywords
- Patients with moderate to severe RA
- 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 |
|---|---|---|
| Patients with moderate to severe RA | Patients with moderate to severe RA treated with Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time.
Measured: after 24 weeks of treatment with tocilizumab
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionDec 2010
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 University Hospital, GhentThe 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Investigators
- Filip De Keyser, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00938444
- Sponsor's protocol ID
- 2009/190
- Other IDs
- ML22613
- Status last verified
- Jul 2011
- First submitted
- 10 Jul 2009
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Janssens X, Decuman S, De Keyser F; Brada I study group. Construction and psychometric properties of the Belgian Rheumatoid Arthritis Disability Assessment (BRADA) questionnaire: a new tool for the evaluation of activity limitations in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2013 Jul-Aug;31(4):596-605. Epub 2013 Jul 30.
PubMed 23899969
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Non-interventional Study in RA Patients Treated With Tocilizumab - Evaluation of the BRADA and ABILHAND Questionnaires
- ClinicalTrials.gov ID
- NCT00938444
- Acronym / sponsor ID
- 2009/190
- Conditions
- Rheumatoid Arthritis
- Keywords
- Patients with moderate to severe RA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 13 Jul 2009 (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 protocol is designed to evaluate the BRADA and ABILHAND questionnaires in rheumatoid arthritis (RA) patients that will be treated with an effective therapy. Patients with moderate to severe RA treated with tocilizumab will be asked to complete the BRADA and ABILHAND questionnaires at screening, baseline, after 12 weeks and after 24 weeks of treatment. All other assessments and questionnaires from daily clinical practice (such as the global assessment of disease activity by the patient, the Health Assessment Questionnaire (HAQ), the SF36 questionnaire, measurement of ESR and CRP and the DAS 28 calculation), will also be used to evaluate these questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with moderate to severe RA | – | –Patients with moderate to severe RA treated with Tocilizumab |
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 RA.
Key inclusion criteria (4 listed)
- patients with moderate to severe RA.
- Inadequate response on earlier optimal use of a minimum of two DMARDs (disease modifying anti-rheumatic drugs such as goldsalts, salazopyrine, leflunomide, methotrexate (MTX)) as far as one of the two used DMARDs is MTX that at the exception of a documented intolerance despite the association with folic acid, should have been administered IM or oral during a minimum of 3 months and at a minimal dose of 15mg/week.
- DAS 28 score ≥ 5.1
- For whom a drug that is registered for the treatment of moderate to severe RA is commercially available but does not constitute a satisfactory treatment for this patient.
Key exclusion criteria (0 listed)
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
Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time.
Time frame: after 24 weeks of treatment with tocilizumab
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 14 Jul 2011.
- Derived from this study: PubMed 23899969Janssens X, Decuman S, De Keyser F; Brada I study group. Construction and psychometric properties of the Belgian Rheumatoid Arthritis Disability Assessment (BRADA) questionnaire: a new tool for the evaluation of activity limitations in patients with rheumatoid arthritis. Clin Exp Rheumatol. 2013 Jul-Aug;31(4):596-605. Epub 2013 Jul 30.
- website of the University Hospital GhentLink provided by the sponsor.
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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.
Filip De Keyser, MD, PhD principal investigator
University Hospital, Ghent
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 University Hospital, Ghent at 19 sites in Belgium.
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 4 inclusion and 0 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 14 Jul 2011. 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 Belgium. 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?
Evaluation of the BRADA and ABILHAND questionnaires to detect clinically important changes over time. (time frame: after 24 weeks of treatment with tocilizumab). 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 NCT00938444, 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 14 Jul 2011.