Rheumatoid ArthritisNCT01564901
An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 13 sites in Spain.
Trial summary
This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 23 participants
- Where
- 13 sitesSpain
- Study dates
- Jan 2012to Oct 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 and concomitant treatment with glucocorticoids
Who may be able to join
- Adults patients, over 18 years of age
- Patients with moderate to severe rheumatoid arthritis (RA)
- Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion
Who cannot join
- Patients previously treated with RoActemra/Actemra
- Any contraindication to RoActemra/Actemra
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Spain13 sites
Study site
Alicante, Alicante, 03700
Study site
Alzira, Valencia, 46600
Study site
Bilbao, Vizcaya, 48013
Study site
Donostia / San Sebastian, Guipuzcoa, 20080
Study site
Elche, Alicante, 03203
Study site
Huesca, Huesca, 22004
Study site
León, Leon, 24071
Study site
Palma de Mallorca, Balearic Islands, 07198
Study site
Ponferrada, Leon, 24411
Study site
Salamanca, Salamanca, 37007
Study site
Valencia, Valencia, 46340
Study site
Valencia, Valencia, 46520
Study site
Vitoria-Gasteiz, Alava, 01009
About this study
Official title: A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.
This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.
- 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.
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day
Measured: Week 36
Secondary outcomes (11)
Change from baseline in glucocorticoid dose
Measured: Week 36
Change from baseline in corticosteroid dose
Measured: Week 36
Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose
Measured: Week 36
Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids
Measured: Week 36
Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use
Measured: Week 36
Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day
Measured: Week 36
Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day
Measured: Week 36
Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction
Measured: Week 36
Percentage change in Disease Activity Score 28 (DAS28)
Measured: Week 36
Percentage change in Simplified Disease Activity Index (SDAI) score
Measured: Week 36
Safety: Incidence of adverse events
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionOct 2012
- Study completionOct 2012
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
- 23 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
- NCT01564901
- Sponsor's protocol ID
- ML27904
- Status last verified
- Nov 2016
- First submitted
- 16 Feb 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
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
- A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.
- ClinicalTrials.gov ID
- NCT01564901
- Acronym / sponsor ID
- ML27904
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 28 Mar 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 prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.
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 and concomitant treatment with glucocorticoids
Key inclusion criteria (3 listed)
- Adults patients, over 18 years of age
- Patients with moderate to severe rheumatoid arthritis (RA)
- Patients on a stable dose of prednisone or equivalent (>/=7.5 mg/day) for at least 4 weeks before study inclusion
Key exclusion criteria (2 listed)
- Patients previously treated with RoActemra/Actemra
- Any contraindication to 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
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day
Time frame: Week 36
11 secondary outcomes
Change from baseline in glucocorticoid dose
Time frame: Week 36
Change from baseline in corticosteroid dose
Time frame: Week 36
Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose
Time frame: Week 36
Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids
Time frame: Week 36
Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use
Time frame: Week 36
Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day
Time frame: Week 36
Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day
Time frame: Week 36
Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction
Time frame: Week 36
Percentage change in Disease Activity Score 28 (DAS28)
Time frame: Week 36
Percentage change in Simplified Disease Activity Index (SDAI) score
Time frame: Week 36
Safety: Incidence of adverse events
Time frame: 36 weeks
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.
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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
13 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 13 sites in Spain.
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 3 inclusion and 2 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 13 sites in Spain. 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?
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day (time frame: Week 36). 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 2 Nov 2016.