Rheumatoid ArthritisPhase 1NCT02371096
Comparative Pharmacokinetic Trial of RGB-03 and MabThera
A Phase 1 study testing MabThera (rituximab) and RGB-03 in people with Rheumatoid Arthritis, run by Gedeon Richter Plc..
Trial summary
Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis. 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?
- MabThera (rituximab) and RGB-03
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento Jun 2016
- Phase
- Phase 1
- 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
- Adult, Older adult
Who may be able to join
- Active Rheumatoid Arthritis
- Inadequate response or intolerance to other DMARDs and anti-TNFs
- Treatment with Methotrexate
Who cannot join
- Previous treatment with rituximab
- Patients with systemic manifestations of rheumatoid arthritis
- Patients seropositive for HIV, HCV, HBV
- Female patients nursing
- Other protocol-defined inclusion/exclusion criteria may apply.
About this study
Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.
- Conditions
- Rheumatoid Arthritis
- Being tested
- MabThera (rituximab), RGB-03
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MabThera (rituximab)Drug
RGB-03Drug
| Study group | Role | What they receive |
|---|---|---|
| RGB-03 | Experimental | Not described Receives: Drug: RGB-03 |
| MabThera (rituximab) | Active comparator | Not described Receives: Drug: MabThera (rituximab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the serum concentration versus time curve (AUC)
Measured: 0-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Primary completionJun 2016 (estimated)
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.
- 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 1
Sponsor and investigators
- Lead sponsor
- Gedeon Richter Plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371096
- Sponsor's protocol ID
- RGB-03-104
- Status last verified
- Feb 2015
- First submitted
- 5 Feb 2015
- Last updated
- 25 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Pharmacokinetic Trial of RGB-03 and MabThera
- ClinicalTrials.gov ID
- NCT02371096
- Acronym / sponsor ID
- RGB-03-104
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Gedeon Richter Plc.Industry (pharma, biotech, devices)
- Primary completion
- Jun 2016 (estimated)
- First posted
- 25 Feb 2015 (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.
Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGB-03 | Experimental | Drug: RGB-03 |
| MabThera (rituximab) | Active comparator | Drug: MabThera (rituximab) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active Rheumatoid Arthritis
- Inadequate response or intolerance to other DMARDs and anti-TNFs
- Treatment with Methotrexate
Key exclusion criteria (5 listed)
- Previous treatment with rituximab
- Patients with systemic manifestations of rheumatoid arthritis
- Patients seropositive for HIV, HCV, HBV
- Female patients nursing
- Other protocol-defined inclusion/exclusion criteria may apply.
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 |
|---|---|---|
| MabThera (rituximab) | Drug | MabThera (rituximab) |
| RGB-03 | Drug | RGB-03 |
Primary outcome
Area under the serum concentration versus time curve (AUC)
Time frame: 0-24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MabThera (rituximab) and RGB-03 in people with Rheumatoid Arthritis, run by Gedeon Richter Plc..
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Area under the serum concentration versus time curve (AUC) (time frame: 0-24 weeks). 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 25 Feb 2015; AzTrials last refreshed its copy on 7 Nov 2026.