Rheumatoid ArthritisNCT01375478
An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 13 sites in Greece.
Trial summary
This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 197 participants
- Where
- 13 sitesGreece
- Study dates
- Apr 2011to Apr 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 rheumatoid arthritis
Who may be able to join
- Adult patients, over 18 years of age
- Moderate to severe rheumatoid arthritis
- RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form
Who cannot join
- Patients with rheumatic autoimmune disease other than rheumatoid arthritis
- Patients who are not willing to sign the informed consent form
- Patients who participate in interventional trials during the period of this observational study
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Greece13 sites
Study site
Athens, 11521
Study site
Athens, 14527
Study site
Athens, 155 62
Study site
Crete, 71110
Study site
Pátrai, 26335
Study site
Pátrai, 26443
Study site
Pátrai, 265 04
Study site
Rhodes, 851 00
Study site
Thessaloniki, 546 42
Study site
Thessaloniki, 54636
Study site
Thessaloniki, 54643
Study site
Thessaloniki, 56429
Study site
Voula, 16673
About this study
Official title: Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)
This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.
- 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 who remained under continued RoActemra/Actemra treatment
Measured: 6 months
Secondary outcomes (5)
Reasons for withdrawal
Measured: 6 months
Frequency of withdrawal
Measured: 6 months
Frequency of dose modification
Measured: 6 months
Reasons for dose modification
Measured: 6 months
Safety: Incidence of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 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
- Retrospective
- Enrolment
- 197 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
- NCT01375478
- Sponsor's protocol ID
- ML25580
- Status last verified
- Nov 2016
- First submitted
- 16 Jun 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
- Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)
- ClinicalTrials.gov ID
- NCT01375478
- Acronym / sponsor ID
- ML25580
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 17 Jun 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 open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- 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 rheumatoid arthritis
Key inclusion criteria (3 listed)
- Adult patients, over 18 years of age
- Moderate to severe rheumatoid arthritis
- RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form
Key exclusion criteria (3 listed)
- Patients with rheumatic autoimmune disease other than rheumatoid arthritis
- Patients who are not willing to sign the informed consent form
- Patients who participate in interventional trials during the period of this observational study
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 who remained under continued RoActemra/Actemra treatment
Time frame: 6 months
5 secondary outcomes
Reasons for withdrawal
Time frame: 6 months
Frequency of withdrawal
Time frame: 6 months
Frequency of dose modification
Time frame: 6 months
Reasons for dose modification
Time frame: 6 months
Safety: Incidence of adverse events
Time frame: 6 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.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
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 Greece.
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 3 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 Greece. 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 who remained under continued RoActemra/Actemra treatment (time frame: 6 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.