Rheumatoid ArthritisPhase 4NCT00576433
A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Had an Inadequate Response to a Single Anti-TNF Inhibitor.
A Phase 4 study testing Methotrexate and rituximab [MabThera/Rituxan] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 18 sites in Russia.
Trial summary
This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Methotrexate and rituximab [MabThera/Rituxan]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 18 sitesRussia
- Study dates
- Dec 2007to Nov 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients, 18-80 years of age;
- moderate to severe active rheumatoid arthritis;
- inadequate response to previous or current treatment with 1 anti-TNF agent;
- receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.
Who cannot join
- previous treatment with MabThera;
- use of an anti-TNF alpha agent within 8 weeks of study start;
- concurrent treatment with any DMARD other than methotrexate;
- active infection, or history of serious recurrent or chronic infection.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
Russia18 sites
Study site
Chelyabinsk, 454076
Study site
Irkutsk, 664047
Study site
Kazan', 420012
Study site
Khabarovsk, 680009
Study site
Khanty-Mansiysk, 628011
Study site
Kursk, 305007
Study site
Moscow, 115522
Study site
Nizhny Novgorod, 603126
Study site
Novosibirsk, 630099
Study site
Novosibirsk, 630117
Study site
Ryazan, 390026
Study site
Saint Petersburg, 195067
Study site
Tyumen, 625023
Study site
Ufa, 450005
Study site
Vladivostok, 690050
Study site
Voronezh, 394066
Study site
Yaroslavl, 150062
Study site
Yekaterinburg, 620102
About this study
Official title: An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor
This single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Methotrexate, rituximab [MabThera/Rituxan]
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
As prescribed
rituximab [MabThera/Rituxan]Drug
1000mg iv on days 1 and 15
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Methotrexate; Drug: rituximab [MabThera/Rituxan] |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs, including infusion-related adverse events
Measured: For 48 weeks after initial treatment
Secondary outcomes (3)
Safety of re-treatment (AEs)
Measured: For 24 weeks after re-treatment.
Laboratory parameters, vital signs.
Measured: Throughout study
ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.
Measured: For 48 weeks after initial treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionNov 2010
- Study completionNov 2010
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT00576433
- Sponsor's protocol ID
- ML21271
- Status last verified
- Nov 2016
- First submitted
- 18 Dec 2007
- 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
- An Open Label Study to Evaluate the Safety and Effect on Treatment Response of MabThera in Patients With Rheumatoid Arthritis Following Inadequate Response to One Prior Anti-TNF Inhibitor
- ClinicalTrials.gov ID
- NCT00576433
- Acronym / sponsor ID
- ML21271
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Dec 2007 (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 single arm study will evaluate the safety and efficacy of MabThera in patients with active rheumatoid arthritis who are receiving methotrexate treatment, and who have had an inadequate response to one anti-TNF alpha therapy. All patients will receive MabThera 1000mg i.v. on days 1 and 15, in addition to concomitant methotrexate. Patients who achieve a clinically relevant response to the first course of treatment may be eligible to receive one re-treatment course of MabThera between weeks 24 and 48. The anticipated time on study treatment is 3-12 months, and the target sample size is 100 individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Methotrexate, Drug: rituximab [MabThera/Rituxan] |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- adult patients, 18-80 years of age;
- moderate to severe active rheumatoid arthritis;
- inadequate response to previous or current treatment with 1 anti-TNF agent;
- receiving methotrexate at a dose of 10-25mg/week for 12 weeks prior to start of study, at a stable dose for >=4 weeks.
Key exclusion criteria (4 listed)
- previous treatment with MabThera;
- use of an anti-TNF alpha agent within 8 weeks of study start;
- concurrent treatment with any DMARD other than methotrexate;
- active infection, or history of serious recurrent or chronic infection.
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 |
|---|---|---|
| MethotrexateAs prescribed | Drug | 1 |
| rituximab [MabThera/Rituxan]1000mg iv on days 1 and 15 | Drug | 1 |
Primary outcome
AEs, including infusion-related adverse events
Time frame: For 48 weeks after initial treatment
3 secondary outcomes
Safety of re-treatment (AEs)
Time frame: For 24 weeks after re-treatment.
Laboratory parameters, vital signs.
Time frame: Throughout study
ACR 20/50/70, Eular response rates, DAS 28, ACR core components, HAQ, FACIT.
Time frame: For 48 weeks after initial treatment.
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.
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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
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and rituximab [MabThera/Rituxan] in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 18 sites in Russia.
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 4 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: 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 18 sites in Russia. 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.
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 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?
AEs, including infusion-related adverse events (time frame: For 48 weeks after initial treatment). 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.