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Comparative Pharmacokinetic Trial of RGB-03 and MabThera

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02371096
Enrollment
Unknown
Registered
2015-02-25
Start date
Unknown
Completion date
Unknown
Last updated
2015-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

Pharmacokinetic properties, efficacy, safety and tolerability of RGB-03 and MabThera will be compared in patients suffering from Rheumatoid Arthritis.

Interventions

DRUGMabThera (rituximab)
DRUGRGB-03

Sponsors

Gedeon Richter Plc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years

Inclusion criteria

* Active Rheumatoid Arthritis * Inadequate response or intolerance to other DMARDs and anti-TNFs * Treatment with Methotrexate

Exclusion criteria

* Previous treatment with rituximab * Patients with systemic manifestations of rheumatoid arthritis * Patients seropositive for HIV, HCV, HBV * Female patients nursing Other protocol-defined inclusion/

Design outcomes

Primary

MeasureTime frame
Area under the serum concentration versus time curve (AUC)0-24 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026