Comparative Pharmacokinetic Trial of RGB-03 and MabThera

NCT ID: NCT02371096

Last Updated: 2015-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Groups

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RGB-03

Group Type EXPERIMENTAL

RGB-03

Intervention Type DRUG

MabThera (rituximab)

Group Type ACTIVE_COMPARATOR

MabThera (rituximab)

Intervention Type DRUG

Interventions

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MabThera (rituximab)

Intervention Type DRUG

RGB-03

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gedeon Richter Plc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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RGB-03-104

Identifier Type: -

Identifier Source: org_study_id

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