Rheumatoid ArthritisNCT02622503
A Study on Rheumatoid Arthritis Patients Treated With Rituximab
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 5 sites in Finland.
Trial summary
The purpose of the study is to obtain an overall picture of rituximab treatments and treatment responses in RA patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Rituximab
- How many people
- 81 participants
- Where
- 5 sitesFinland
- Study dates
- Apr 2008to Aug 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Rheumatoid arthritis (RA) patients treated with rituximab in Finland.
Who may be able to join
- Rheumatoid arthritis (RA) patients treated with rituximab in Finland
Who cannot join
- Not applicable
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Finland5 sites
Study site
Helsinki, 00290
Study site
Jyväskylä, 40620
Study site
Lahti, 15850
Study site
Tampere, 33520
Study site
Turku, 20520
About this study
Official title: Retrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland.
The purpose of the study is to obtain an overall picture of rituximab treatments and treatment responses in RA patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Rituximab
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
This is an observational study. Patients with rheumatoid arthritis and having received treatment previously will be assessed for the treatment responses.
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatoid arthritis | Patients with rheumatoid arthritis receiving rituximab will be observed for treatment responses. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Information on previous RA treatments
Measured: 3 months
Information on rituximab treatment responses
Measured: 3 months
Information on concomitant medications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2015 (estimated)
- Study startApr 2008
- Primary completionAug 2008
- Study completionAug 2008
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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 81 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
- NCT02622503
- Sponsor's protocol ID
- ML30146
- Status last verified
- Dec 2016
- First submitted
- 2 Dec 2015
- Last updated
- 13 Dec 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Data Collection on Rheumatoid Arthritis (RA) Patients Treated With Rituximab in Finland.
- ClinicalTrials.gov ID
- NCT02622503
- Acronym / sponsor ID
- ML30146
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 4 Dec 2015 (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.
The purpose of the study is to obtain an overall picture of rituximab treatments and treatment responses in RA patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis | – | Drug: RituximabPatients with rheumatoid arthritis receiving rituximab will be observed for treatment responses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Rheumatoid arthritis (RA) patients treated with rituximab in Finland.
Key inclusion criteria (1 listed)
- Rheumatoid arthritis (RA) patients treated with rituximab in Finland
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RituximabThis is an observational study. Patients with rheumatoid arthritis and having received treatment previously will be assessed for the treatment responses. | Drug | Patients with rheumatoid arthritis |
Primary outcome
Information on previous RA treatments
Time frame: 3 months
Information on rituximab treatment responses
Time frame: 3 months
Information on concomitant medications
Time frame: 3 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 13 Dec 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
5 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 5 sites in Finland.
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 1 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 13 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Finland. 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?
Information on previous RA treatments (time frame: 3 months). The study lists 3 primary outcomes in all. 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 13 Dec 2016.