Treatment of TNFa Naive Patients With Poor Prognosis Rheu... | NCT00963703

Studies
Treatment of TNFa Naive Patients With Poor Prognosis Rheumatoid Arthritis

NCT00963703

Sponsor

University of Manitoba

Status

Completed

Last Update Posted

Mar 20, 2012Estimated

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Rheumatoid Arthritis

Interventions

Rituximab

Countries

Canada

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

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Mar 2012Actual

Completion Date

Mar 2012Actual

First Submitted Date

Aug 20, 2009

First Submission Date that Met QC Criteria

Aug 20, 2009

First Posted Date

Aug 21, 2009Estimated

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

Mar 19, 2012

Last Update Posted Date

Mar 20, 2012Estimated

Name	Class
Hoffmann-La Roche	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The purpose of this study is to determine how well Rituximab works in early stages of disease and the effects it has on an inflamed joint and blood cells.

This will allow the investigators to get a better understanding of how this treatment affects the inflamed joints of rheumatoid arthritis (RA) patients.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rituximab	Experimental		Drug: Rituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug	Rituximab 1000 mg Intravenously day 1 and day 15	Rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To define the synovial effects of rituximab treatment in TNFa naive patients with early rheumatoid arthritis		Biopsies of inflamed joint at beginning and at week 8 of study

Secondary Outcomes

Measure	Description	Time Frame
To define the effects of rituximab treatment on the phenotype and function of peripheral blood T and B cells		Collected at beginning of study and week 8

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with documented rheumatoid arthritis by ACR criteria
Disease duration < 5 years
May have previously been treated with methotrexate,hydroxychloroquine or sulfasalazine, either as a single DMARD or in combination
Tender joint count >= 6, swollen joint count >= 6, and one must be a knee
Corticosteroids <= 10 mg per day permitted on stable doses for at least 4 weeks
Patients must consent to 2 arthroscopic synovial biopsy procedures

Exclusion Criteria:

History of severe allergic or anaphylactic reactions to monoclonal antibodies
Previous treatment with Rituximab
Previous treatment with Arava
Injected with steroids within 4 weeks of day 1 of study
Treatment with any investigational agent within 4 weeks of day of study
Any severe or significant medical condition or disease or known active infection
Pregnancy or nursing at present

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Arthritis Centre, University of Manitoba		Winnipeg	Manitoba	R3A 1M4	Canada

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