DMARD Resistant Rheumatoid ArthritisPhase 4NCT01593332
Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
A Phase 4 study testing Rituximab in people with DMARD Resistant Rheumatoid Arthritis, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- DMARD Resistant 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
- 44 participants
- Where
- 1 siteIran
- Study dates
- Jul 2010to Oct 2011
- 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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1987 ACR criteria for classification of RA
- Positive for rheumatoid factor(RF)
- Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 > 3/2
- Patients with active, resistant RA who didn't receive anti TNF agents.
Who cannot join
- Patient with hypogammaglobulinemia
- Patient with congestive heart failure (classIV)
- Active current bacterial,viral,fungal,myocardial or other infections
- Chronic hepatitis B or hepatitis C carriers
- History of severe allergic reaction to human,humanized or murine monoclonal antibodies
- History of malignancies
- Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Rheumatic Diseases Research Center, Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province
About this study
In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.
- Conditions
- DMARD Resistant Rheumatoid Arthritis
- Being tested
- Rituximab
- Keywords
- Rituximab, Rheumatoid arthritis, Biologics, Anti-tumour necrosis factor, Disease-modifying anti-rheumatic drugs, DAS28, European League Against Rheumatism response
- 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
Also called Mabthera
two 500 mg rituximab infusions 2 weeks apart
RituximabDrug
Also called Mabthera
500mg,two times with two weeks interval
| Study group | Role | What they receive |
|---|---|---|
| Rituximab | Active comparator | Not described Receives: Drug: Rituximab |
| Methotrexate | Active comparator | Not described Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in 28-joint disease activity index( DAS28)
disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)
Measured: Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.
Change in European league against rheumatism(EULAR) response criteria
Measured: Change in EULAR 2,16,24 weeks
Secondary outcomes (1)
Rituximab side effects
side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.
Measured: 0,2,16,24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2012 (estimated)
- Study startJul 2010
- Primary completionSep 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DMARD Resistant 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Principal investigator, Kamila Hashemzadeh, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593332
- Sponsor's protocol ID
- 87549
- Other IDs
- 87549
- Status last verified
- May 2012
- First submitted
- 7 Jan 2012
- Last updated
- 8 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01593332
- Acronym / sponsor ID
- 87549
- Conditions
- DMARD Resistant Rheumatoid Arthritis
- Keywords
- Rituximab, Rheumatoid arthritis, Biologics, Anti-tumour necrosis factor, Disease-modifying anti-rheumatic drugs, DAS28, European League Against Rheumatism response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- Jul 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 May 2012 (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.
In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rituximab | Active comparator | Drug: Rituximab |
| Methotrexate | Active comparator | Drug: Rituximab |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1987 ACR criteria for classification of RA
- Positive for rheumatoid factor(RF)
- Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 > 3/2
- Patients with active, resistant RA who didn't receive anti TNF agents.
Key exclusion criteria (7 listed)
- Patient with hypogammaglobulinemia
- Patient with congestive heart failure (classIV)
- Active current bacterial,viral,fungal,myocardial or other infections
- Chronic hepatitis B or hepatitis C carriers
- History of severe allergic reaction to human,humanized or murine monoclonal antibodies
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 |
|---|---|---|
| RituximabAlso: Mabtheratwo 500 mg rituximab infusions 2 weeks apart | Drug | Methotrexate, Rituximab |
| RituximabAlso: Mabthera500mg,two times with two weeks interval | Drug | Methotrexate, Rituximab |
Primary outcome
change in 28-joint disease activity index( DAS28)
Time frame: Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.
disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)
Change in European league against rheumatism(EULAR) response criteria
Time frame: Change in EULAR 2,16,24 weeks
1 secondary outcome
Rituximab side effects
Time frame: 0,2,16,24 weeks
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 8 May 2012.
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 Phase 4 study testing Rituximab in people with DMARD Resistant Rheumatoid Arthritis, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 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 8 May 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 Iran. 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?
change in 28-joint disease activity index( DAS28) (time frame: Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.). The study lists 2 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 8 May 2012.