Rheumatoid ArthritisNCT01392001
An Observational Study of Glucocorticoid Use in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 116 sites in France.
Trial summary
This observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with >5… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 322 participants
- Where
- 116 sitesFrance
- Study dates
- Mar 2011to Apr 2013
- 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: Rheumatoid arthritis patients on treatment with RoActemra/Actemra and > 5 mg/day prednisone (or equivalent)
Who may be able to join
- Adult patients, >/= 18 years of age
- Patients with rheumatoid arthritis for whom the rheumatologist decided to introduce RoActemra
- Patients taking more than 5 mg/day of oral prednisone (or equivalent) for at least 3 months
Who cannot join
- Participation in a clinical trial in rheumatoid arthritis
Trial locations and contacts
116 sites in 1 country.
116 sites in 1 country
France116 sites
Study site
Abbeville, 80142
Study site
Agen, 47923
Study site
Aix-en-Provence, 13616
Study site
Aix-les-Bains, 73106
Study site
Alençon, 61000
Study site
Amiens, 80000
Study site
Amiens, 80054
Study site
Angers, 49933
Study site
Argenteuil, 95107
Study site
Auch, 32008
Study site
Aulnay-sous-Bois, 93602
Study site
Avignon, 84902
Study site
Bayonne, 64109
Study site
Belfort, 90016
Study site
Belley, 01306
Study site
Berck, 62608
Study site
Besançon, 25030
Study site
Blois, 41016
Study site
Bobigny, 93009
Study site
Bois-Colombes, 92270
Study site
Bondy, 93143
Study site
Bordeaux, 33076
Study site
Brest, 29609
Study site
Caen, 14033
Study site
Cahors, 46000
Study site
Cahors, 46005
Study site
Cambrai, 59407
Study site
Cannes, 06401
Study site
Carcassonne, 11890
Study site
Chambray-lès-Tours, 37171
Study site
Clermont-Ferrand, 63003
Study site
Compiègne, 60321
Study site
Corbeil-essones, 91106
Study site
Corbeil-Essonnes, 91106
Study site
Dijon, 21000
Study site
Dole, 39108
Study site
Druex, 28102
Study site
Évian-les-Bains, 74500
Study site
Évreux, 27023
Study site
Évry, 91024
Study site
Fréjus, 83608
Study site
Gap, 05000
Study site
Gleizé, 69400
Study site
La Roche-sur-Yon, 85925
Study site
Laon, 02001
Study site
Lavaur, 81500
Study site
Le Coudray, 28630
Study site
Le Kremlin-Bicêtre, 94275
Study site
Libourne, 33505
Study site
Liévin, 62806
Study site
Lille, 59037
Study site
Limoges, 87042
Study site
Lomme, 59462
Study site
Lorient, 56322
Study site
Lyon, 69002
Study site
Lyon, 69275
Study site
Lyon, 69365
Study site
Lyon, 69437
Study site
Maisons-Laffitte, 78600
Study site
Mandelieu-la-Napoule, 06210
Study site
Marseille, 13015
Study site
Marseille, 13274
Study site
Marseille, 13285
Study site
Marseille, 13384
Study site
Marseille, 13385
Study site
Meaux, 77104
Study site
Metz-Tessy, 74370
Study site
Montauban, 82017
Study site
Montpellier, 34295
Study site
Morlaix, 29672
Study site
Moulins, 03000
Study site
Mulhouse, 68070
Study site
Nanterre, 92014
Study site
Nantes, 44035
Study site
Narbonne, 11108
Study site
Nice, 06202
Study site
Nîmes, 30029
Study site
Niort, 79021
Study site
Paris, 75475
Study site
Paris, 75571
Study site
Paris, 75651
Study site
Paris, 75674
Study site
Paris, 75877
Study site
Paris, 75960
Study site
Perpignan, 66046
Study site
Pierre-Bénite, 69495
Study site
Poissy, 78303
Study site
Pontoise, 95300
Study site
Reims, 51092
Study site
Rodez, 12027
Study site
Roubaix, 59056
Study site
Saint-Chamond, 42403
Study site
Saint-Flour, 15100
Study site
Saint-Mandé, 94163
Study site
Saint-Nazaire, 44606
Study site
Saint-Priest-en-Jarez, 42277
Study site
Saint-Quentin, 02109
Study site
Salon-de-Provence, 13658
Study site
Ste Maxime, 83120
Study site
Suresnes, 92151
Study site
Thionville, 57126
Study site
Toulon, 83000
Study site
Toulon, 83041
Study site
Toulon, 83056
Study site
Toulon, 83100
Study site
Toulouse, 31059
Study site
Toulouse, 31076
Study site
Toulouse, 31077
Study site
Tourcoing, 59208
Study site
Valenciennes, 59322
Study site
Vandœuvre-lès-Nancy, 54511
Study site
Vannes, 56017
Study site
Vienne, 38209
Study site
Villefranche-sur-Saône, 69400
Study site
Villeurbanne, 69626
Study site
Vlleneuve Sur Lot, 47307
About this study
Official title: Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.
This observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 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.
Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra
Measured: approximately 29 months
Secondary outcomes (4)
Efficacy: Disease activity score (DAS 28)
Measured: approximately 29 months
Co-medications: dosage and treatment schedules
Measured: approximately 29 months
Patient reported outcome: European League against Rheumatism - Rheumatoid Arthritis Impact of Disease score (EULAR-RAID)/Health Assessment Questionnaire - Disease Index (HAQ-DI)
Measured: approximately 29 months
Safety: Incidence of adverse events
Measured: approximately 29 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2013
- Study completionApr 2013
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
- 322 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
- NCT01392001
- Sponsor's protocol ID
- ML25634
- Status last verified
- Nov 2016
- First submitted
- 8 Jul 2011
- 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
- Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.
- ClinicalTrials.gov ID
- NCT01392001
- Acronym / sponsor ID
- ML25634
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 12 Jul 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 glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 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
- Rheumatoid arthritis patients on treatment with RoActemra/Actemra and > 5 mg/day prednisone (or equivalent)
Key inclusion criteria (3 listed)
- Adult patients, >/= 18 years of age
- Patients with rheumatoid arthritis for whom the rheumatologist decided to introduce RoActemra
- Patients taking more than 5 mg/day of oral prednisone (or equivalent) for at least 3 months
Key exclusion criteria (1 listed)
- Participation in a clinical trial in rheumatoid arthritis
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
Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra
Time frame: approximately 29 months
4 secondary outcomes
Efficacy: Disease activity score (DAS 28)
Time frame: approximately 29 months
Co-medications: dosage and treatment schedules
Time frame: approximately 29 months
Patient reported outcome: European League against Rheumatism - Rheumatoid Arthritis Impact of Disease score (EULAR-RAID)/Health Assessment Questionnaire - Disease Index (HAQ-DI)
Time frame: approximately 29 months
Safety: Incidence of adverse events
Time frame: approximately 29 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.
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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
116 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 116 sites in France.
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 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 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 116 sites in France. 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?
Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra (time frame: approximately 29 months). 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; AzTrials last refreshed its copy on 7 Nov 2026.