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Comparative Pharmacokinetic Trial of RGB-03 and MabThera

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
MabThera (rituximab)
RGB-03
Sponsored by
Gedeon Richter Plc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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/exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    RGB-03

    MabThera (rituximab)

    Arm Description

    Outcomes

    Primary Outcome Measures

    Area under the serum concentration versus time curve (AUC)

    Secondary Outcome Measures

    Full Information

    First Posted
    February 5, 2015
    Last Updated
    February 19, 2015
    Sponsor
    Gedeon Richter Plc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02371096
    Brief Title
    Comparative Pharmacokinetic Trial of RGB-03 and MabThera
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Gedeon Richter Plc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Study Phase
    Phase 1

    8. Arms, Groups, and Interventions

    Arm Title
    RGB-03
    Arm Type
    Experimental
    Arm Title
    MabThera (rituximab)
    Arm Type
    Active Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    MabThera (rituximab)
    Intervention Type
    Drug
    Intervention Name(s)
    RGB-03
    Primary Outcome Measure Information:
    Title
    Area under the serum concentration versus time curve (AUC)
    Time Frame
    0-24 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Eligibility Criteria
    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/exclusion criteria may apply.

    12. IPD Sharing Statement

    Learn more about this trial

    Comparative Pharmacokinetic Trial of RGB-03 and MabThera

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