Rheumatoid ArthritisPhase 4NCT01117129
A Study of Efficacy of Rituximab [Mabthera/Rituxan] in Patients With Rheumatoid Arthritis Using Magnetic Resonance Imaging of the Hand (RESONAR)
A Phase 4 study testing rituximab [MabThera/Rituxan] and methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in Spain.
Trial summary
This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- rituximab [MabThera/Rituxan] and methotrexate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2010to Jun 2010
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-75 years of age
- active rheumatoid arthritis (DAS28-CRP>3.2)
- refractory to one or more anti-TNF
- on stable treatment for RA for >/=4 weeks
- evidence of erosive disease and/or synovitis in wrist and/or knuckles
Who cannot join
- active systemic or local infection
- previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia
- signs of immunodeficiency, HIV infection or tuberculosis
- contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)
This randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is <50 patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- rituximab [MabThera/Rituxan], placebo, methotrexate
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximab [MabThera/Rituxan]Drug
1000 mg by i.v. infusion on day 1 and 15
placeboDrug
i.v. infusion on day 1 and 15
methotrexateDrug
10-25 mg weekly
rituximab [Mabthera/Rituxan]Drug
1000 mg by i.v. infusion on day 1 and 15, 2nd and further cycles in patients with (group A) or without (group B) clinical response in cycle 1
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: rituximab [MabThera/Rituxan]; Drug: methotrexate |
| B | Placebo comparator | Not described Receives: Drug: placebo; Drug: methotrexate; Drug: rituximab [Mabthera/Rituxan] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)
Measured: 6 months
Secondary outcomes (6)
Synovitis score on MRI using RAMRIS
Measured: months 6, 12 and 24
Bone edema score on MRI using RAMRIS
Measured: months 6, 12 and 24
Bone erosion score on MRI using RAMRIS
Measured: months 12 and 24
Disease activity according to DAS28-CRP
Measured: months 12 and 24
Tender or swollen joint count (ACR criteria)
Measured: months 12 and 24
Health assessment questionnaire (HAQ)
Measured: months 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2010
- Study completionJun 2010
Why it stopped: This study was prematurely terminated as 2 patients were recruited and both of them withdrawn from the study before reaching the primary end point.
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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 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
- NCT01117129
- Sponsor's protocol ID
- ML21826
- Other IDs
- 2008-002381-55, 2008
- Status last verified
- Mar 2014
- First submitted
- 4 May 2010
- Last updated
- 28 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of MabThera in Patients With Rheumatoid Arthritis, by Measurement of Disease Parameters Through Magnetic Resonance of the Hand (RESONAR Study)
- ClinicalTrials.gov ID
- NCT01117129
- Acronym / sponsor ID
- ML21826
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was prematurely terminated as 2 patients were recruited and both of them withdrawn from the study before reaching the primary end point.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 5 May 2010 (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 randomized, double-blind, placebo controlled, parallel group study will assess the efficacy and safety of rituximab [MabThera/Rituxan] in patients with severe active rheumatoid arthritis refractory to at least one anti-TNF treatment, using magnetic resonance imaging (MRI) of the hand for efficacy measurement. Patients will be randomized to receive 2 intravenous infusions 14 days apart of either 1000mg MabThera (group A) or placebo (group B). All patients will receive methotrexate 10-25mg weekly. Patients in group A demonstrating clinical response at week 24 may receive further cycles of MabThera, patients in group B without clinical response will also be treated with active MabThera. Anticipated time on study treatment is up to 2 years. Target sample size is <50 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: rituximab [MabThera/Rituxan], Drug: methotrexate |
| B | Placebo comparator | Drug: placebo, Drug: methotrexate, Drug: rituximab [Mabthera/Rituxan] |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- adult patients, 18-75 years of age
- active rheumatoid arthritis (DAS28-CRP>3.2)
- refractory to one or more anti-TNF
- on stable treatment for RA for >/=4 weeks
- evidence of erosive disease and/or synovitis in wrist and/or knuckles
Key exclusion criteria (4 listed)
- active systemic or local infection
- previous or current history of any demyelinization process in central nervous system, pancytopenia or aplasic anaemia
- signs of immunodeficiency, HIV infection or tuberculosis
- contraindications to MRI, such as metal devices, claustrophobia, moderate or severe renal insufficiency, or allergy to contrast agent
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 |
|---|---|---|
| rituximab [MabThera/Rituxan]1000 mg by i.v. infusion on day 1 and 15 | Drug | A |
| placeboi.v. infusion on day 1 and 15 | Drug | B |
| methotrexate10-25 mg weekly | Drug | A, B |
| rituximab [Mabthera/Rituxan]1000 mg by i.v. infusion on day 1 and 15, 2nd and further cycles in patients with (group A) or without (group B) clinical response in cycle 1 | Drug | A, B |
Primary outcome
Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS)
Time frame: 6 months
6 secondary outcomes
Synovitis score on MRI using RAMRIS
Time frame: months 6, 12 and 24
Bone edema score on MRI using RAMRIS
Time frame: months 6, 12 and 24
Bone erosion score on MRI using RAMRIS
Time frame: months 12 and 24
Disease activity according to DAS28-CRP
Time frame: months 12 and 24
Tender or swollen joint count (ACR criteria)
Time frame: months 12 and 24
Health assessment questionnaire (HAQ)
Time frame: months 12 and 24
Results and safety
The study was stopped early (reason given: This study was prematurely terminated as 2 patients were recruited and both of them withdrawn from the study before reaching the primary end point.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2014.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing rituximab [MabThera/Rituxan] and methotrexate in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 1 site in Spain.
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 5 inclusion and 4 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: stopped early, as of the sponsor's last update on 28 Mar 2014. 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 Spain. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was prematurely terminated as 2 patients were recruited and both of them withdrawn from the study before reaching the primary end point.). Results are not available in the source record.
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?
Bone erosion score on magnetic resonance imaging (MRI) using the rheumatoid arthritis magnetic resonance imaging scoring system (RAMRIS) (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 28 Mar 2014.