Rheumatoid ArthritisKuoRituxi1NCT00854321
Patients With Rheumatoid Arthritis (RA) Treated With Rituximab in Kuopio University Hospital
An observational study of Rheumatoid Arthritis, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
One centre follow-up study on safety and efficacy of treatment with rituximab among patients with RA during 4 year period. Basic data is collected for the national register of biologicals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- rituximab and rituximab, observational study amon patients with active RA
- Type of treatment
- Injection or infusion
- How many people
- 49 participants
- Where
- 1 siteFinland
- Study dates
- Nov 2004to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with active RA in one centre
Who may be able to join
- active RA without response to earlier treatment
Who cannot join
- contraindications to rituximab
Trial locations and contacts
1 site in 1 country.
About this study
Official title: One Centre Follow-up Study on Safety and Efficacy
One centre follow-up study on safety and efficacy of treatment with rituximab among patients with RA during 4 year period. Basic data is collected for the national register of biologicals.
Read the detailed description
Data is collected on regular visits in the outpatient department. In collection national register forms have been used.
- Conditions
- Rheumatoid Arthritis
- Being tested
- rituximab, rituximab, observational study amon patients with active RA
- Keywords
- rheumatoid arthritis, rituximab, therapy
- 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
rituximab two 1000 mg intravenous infusions separated by two weeks
rituximab, observational study amon patients with active RADrug
two 1000 mg intravenous infusions separated by 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| patients with active RA | drug, follow-up Receives: Drug: rituximab; Drug: rituximab, observational study amon patients with active RA |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR20 ACR50 ACR70 response
Measured: 6 and 12 months
Secondary outcomes (1)
Duration of clinical response
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2009 (estimated)
- Study startNov 2004
- Primary completionJul 2008
- Study completionJul 2008
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.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Oili Kaipiainen-Seppänen, MD, Study director, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00854321
- Sponsor's protocol ID
- KuoRituxi1
- Acronym
- KuoRituxi1
- Status last verified
- Mar 2009
- First submitted
- 2 Mar 2009
- Last updated
- 3 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Keystone E, Burmester GR, Furie R, Loveless JE, Emery P, Kremer J, Tak PP, Broder MS, Yu E, Cravets M, Magrini F, Jost F. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2008 Jun 15;59(6):785-93. doi: 10.1002/art.23715.
PubMed 18512710
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One Centre Follow-up Study on Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00854321
- Acronym / sponsor ID
- KuoRituxi1 / KuoRituxi1
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, rituximab, therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Study start
- Nov 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Mar 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.
One centre follow-up study on safety and efficacy of treatment with rituximab among patients with RA during 4 year period. Basic data is collected for the national register of biologicals.
Detailed description
Data is collected on regular visits in the outpatient department. In collection national register forms have been used.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with active RA | – | Drug: rituximab, Drug: rituximab, observational study amon patients with active RAdrug, follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with active RA in one centre
Key inclusion criteria (1 listed)
- active RA without response to earlier treatment
Key exclusion criteria (1 listed)
- contraindications to rituximab
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 |
|---|---|---|
| rituximabrituximab two 1000 mg intravenous infusions separated by two weeks | Drug | patients with active RA |
| rituximab, observational study amon patients with active RAtwo 1000 mg intravenous infusions separated by 2 weeks | Drug | patients with active RA |
Primary outcome
ACR20 ACR50 ACR70 response
Time frame: 6 and 12 months
1 secondary outcome
Duration of clinical response
Time frame: 6 and 12 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 3 Mar 2009.
- Background: PubMed 18512710Keystone E, Burmester GR, Furie R, Loveless JE, Emery P, Kremer J, Tak PP, Broder MS, Yu E, Cravets M, Magrini F, Jost F. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2008 Jun 15;59(6):785-93. doi: 10.1002/art.23715.
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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.
Oili Kaipiainen-Seppänen, MD study director
Kuopio University Hospital
1 site 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 Kuopio University Hospital at 1 site 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 3 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
ACR20 ACR50 ACR70 response (time frame: 6 and 12 months). 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 NCT00854321, 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 3 Mar 2009.