Rheumatoid ArthritisNCT00963703
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis
A study testing Rituximab in people with Rheumatoid Arthritis, run by University of Manitoba at 1 site in Canada.
Trial summary
The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells. This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients. 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2007to Mar 2012
- Phase
- Interventional
- 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
Who may be able to join
- Patients with documented rheumatoid arthritis by ACR criteria
- Disease duration < 5 years
- May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
- Tender joint count >= 6, swollen joint count >= 6, and one must be a knee
- Corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks
- Patients must consent to 2 arthroscopic synovial biopsy procedures
Who cannot join
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- Previous treatment with Rituximab
- Previous treatment with Arava
- Injected with steroids within 4 weeks of day 1 of study
- Treatment with any investigational agent within 4 weeks of day of study
- Any severe or significant medical condition or disease or known active infection
- Pregnancy or nursing at present
Trial locations and contacts
1 site in 1 country.
Canada1 site
Arthritis Centre, University of Manitoba
Winnipeg, Manitoba, R3A 1M4
About this study
Official title: Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes
The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.
This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (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
Rituximab 1000 mg Intravenously day 1 and day 15
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Experimental | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis
Measured: Biopsies of inflamed joint at beginning and at week 8 of study
Secondary outcomes (1)
To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells
Measured: Collected at beginning of study and week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startDec 2007
- Primary completionMar 2012
- Study completionMar 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 University of ManitobaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963703
- Sponsor's protocol ID
- B2007:160
- Status last verified
- Mar 2012
- First submitted
- 20 Aug 2009
- Last updated
- 20 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis Using Rituximab: A Pilot Study Evaluating Synovial Outcomes
- ClinicalTrials.gov ID
- NCT00963703
- Acronym / sponsor ID
- B2007:160
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Dec 2007
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 21 Aug 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.
The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.
This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Experimental | Drug: Rituximab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with documented rheumatoid arthritis by ACR criteria
- Disease duration < 5 years
- May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
- Tender joint count >= 6, swollen joint count >= 6, and one must be a knee
- Corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks
Key exclusion criteria (7 listed)
- History of severe allergic or anaphylactic reactions to monoclonal antibodies
- Previous treatment with Rituximab
- Previous treatment with Arava
- Injected with steroids within 4 weeks of day 1 of study
- Treatment with any investigational agent within 4 weeks of day of study
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 1000 mg Intravenously day 1 and day 15 | Drug | Rituximab |
Primary outcome
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis
Time frame: Biopsies of inflamed joint at beginning and at week 8 of study
1 secondary outcome
To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells
Time frame: Collected at beginning of study and week 8
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 20 Mar 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rituximab in people with Rheumatoid Arthritis, run by University of Manitoba at 1 site in Canada.
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 6 inclusion and 7 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 20 Mar 2012. 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 Canada. 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?
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis (time frame: Biopsies of inflamed joint at beginning and at week 8 of study). 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 20 Mar 2012.