Comparative Pharmacokinetic Trial of RGB-03 and MabThera | NCT02371096

Studies
Comparative Pharmacokinetic Trial of RGB-03 and MabThera

NCT02371096

Sponsor

Gedeon Richter Plc.

Status

Unknown status

Last Update Posted

Feb 25, 2015Estimated

Enrollment

Not provided

Phase

Phase 1

Conditions

Rheumatoid Arthritis

Interventions

MabThera (rituximab)
RGB-03

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Jun 2016Estimated

Completion Date

Not provided

First Submitted Date

Feb 5, 2015

First Submission Date that Met QC Criteria

Feb 19, 2015

First Posted Date

Feb 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2015

Last Update Posted Date

Feb 25, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RGB-03	Experimental		Drug: RGB-03
MabThera (rituximab)	Active Comparator		Drug: MabThera (rituximab)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MabThera (rituximab)	Drug		MabThera (rituximab)
RGB-03

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the serum concentration versus time curve (AUC)		0-24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069283	Rituximab

Ancestor Terms

ID	Term
D058846	Antibodies, Monoclonal, Murine-Derived
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided