Low Dose Rituximab as a First Line Biologic Therapy for t... | NCT01593332

Studies
Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis

NCT01593332

Sponsor

Mashhad University of Medical Sciences

Status

Completed

Last Update Posted

May 8, 2012Estimated

Enrollment

44Actual

Phase

Phase 4

Conditions

DMARD Resistant Rheumatoid Arthritis

Interventions

Rituximab
Rituximab

Countries

Iran

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

ID	Type	Description	Link
87549	Other Identifier	DEPUTY OF RESEARCH OF MASHHAD UNIVERSITY OF MEDICAL SCIENCES

Status Module

Record Verification Date

May 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

Jul 2010

Primary Completion Date

Sep 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Jan 7, 2012

First Submission Date that Met QC Criteria

May 5, 2012

First Posted Date

May 8, 2012Estimated

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

May 5, 2012

Last Update Posted Date

May 8, 2012Estimated

Name	Class
Roche Pharma AG	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

In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rituximab	Active Comparator		Drug: Rituximab
Methotrexate	Active Comparator		Drug: Rituximab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rituximab	Drug	two 500 mg rituximab infusions 2 weeks apart	Methotrexate Rituximab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in 28-joint disease activity index( DAS28)	disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)	Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.
Change in European league against rheumatism(EULAR) response criteria		Change in EULAR 2,16,24 weeks

Secondary Outcomes

Measure	Description	Time Frame
Rituximab side effects	side effects like infusion reaction , paresthesia, itching,hypertension or hypotension,headache and infection.	0,2,16,24 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1987 ACR criteria for classification of RA
Positive for rheumatoid factor(RF)
Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 > 3/2
Patients with active, resistant RA who didn't receive anti TNF agents.

Exclusion Criteria:

Patient with hypogammaglobulinemia
Patient with congestive heart failure (classIV)
Active current bacterial,viral,fungal,myocardial or other infections
Chronic hepatitis B or hepatitis C carriers
History of severe allergic reaction to human,humanized or murine monoclonal antibodies
History of malignancies
Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

75 Years

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
Rheumatic Diseases Research Center, Mashhad University of Medical Sciences		Mashhad	Razavi Khorasan Province		Iran

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