To Evaluate 1 Year Extension Study of the Efficacy and Sa... | NCT01256736

Studies
To Evaluate 1 Year Extension Study of the Efficacy and Safety of Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis

NCT01256736

Sponsor

JW Pharmaceutical

Status

Completed

Last Update Posted

Nov 20, 2013Estimated

Enrollment

89Actual

Phase

Phase 3

Conditions

Rheumatoid Arthritis

Interventions

Tocilizumab
DMARDs

Countries

South Korea

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

Nov 2013

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

Mar 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Nov 2013Actual

First Submitted Date

Oct 28, 2010

First Submission Date that Met QC Criteria

Dec 7, 2010

First Posted Date

Dec 9, 2010Estimated

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

Nov 18, 2013

Last Update Posted Date

Nov 20, 2013Estimated

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 evaluate 1 year extension study of the efficacy and the safety during treatment tocilizumab in patients completing treatment CWP-TCZ301 study with moderate to severe active RA and an inadequate response to current DMARD.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

89Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tocilizumab 8mg/kg + DMARDs	Experimental		Drug: Tocilizumab Drug: DMARDs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tocilizumab	Drug	intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks	Tocilizumab 8mg/kg + DMARDs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety results	All AE/ADR during study Physical examination including vital signs and ECG Clinical laboratory results	48weeks

Secondary Outcomes

Measure	Description	Time Frame
Proportion of patients with ACR20, ACR50 and ACR70 responses at post therapy		48weeks
Proportion of patients maintain with ACR20, ACR50 and ACR 70 responses at post therapy		48weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients Who have been satisfied the in/exclusion criteria of CWP-TCZ301
Patients who have been withdrawn after receiving escape therapy or completed treatment during 24weeks in CWP-TCZ301 study
Patients who able to enroll in this study within 12 weeks after last infusion of CWP-TCZ301
Willing to give written informed consent

Exclusion Criteria:

History of severe allergic or anaphylactic reactions to Investigational product in CWP-TCZ301 study
ALT or AST > ULNⅹ2.5
Platelet count < 100ⅹ103/ μL
WBC < 3,000/mm3
Absolute neutrophil count < 1,000/mm3
Absolute lymphocyte count < 500/mm3
Total bilirubin > ULNⅹ2

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
Seoul National Univ. Hospital		Seoul		110-744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32508063	Derived	Choi IA, Sagawa A, Lee EY, Lee EB, Song YW. Tocilizumab Increases Body Weight and Serum Adipokine Levels in Patients with Rheumatoid Arthritis Independently of Their Treatment Response: a Retrospective Cohort Study. J Korean Med Sci. 2020 Jun 8;35(22):e155. doi: 10.3346/jkms.2020.35.e155.

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

ID	Term
C502936	tocilizumab
D018501	Antirheumatic Agents

ID	Term
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses