A Double Blind Placebo Controlled Study to Assess the Eff... | NCT00319917

Studies
A Double Blind Placebo Controlled Study to Assess the Efficacy on Joint Damage in RA Patients

NCT00319917

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Aug 21, 2014Estimated

Enrollment

123Actual

Phase

Phase 4

Conditions

Rheumatoid Arthritis

Interventions

tacrolimus
placebo

Countries

Japan

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

Aug 2014

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

Apr 2006

Primary Completion Date

Oct 2008Actual

Completion Date

Oct 2008Actual

First Submitted Date

Apr 27, 2006

First Submission Date that Met QC Criteria

Apr 27, 2006

First Posted Date

Apr 27, 2006Estimated

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

Aug 19, 2014

Last Update Posted Date

Aug 21, 2014Estimated

Description Module

Brief Summary

The purpose of the study is to assess the efficacy on joint damage and safety in RA patients treated with DMARDs in a double blind, placebo controlled study.

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

123Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: tacrolimus
2	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tacrolimus	Drug	oral	1	Prograf FK506

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Radiographic progression of structural joint damage		52 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Signs and symptoms of rheumatoid arthritis		52 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinically diagnosed as rheumatoid arthritis by the revised ACR criteria
Those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine
Those who have at least one erosion on X-ray of hands, wrists or feet

Exclusion Criteria:

Those who have been treated with any biologic drugs or leflunomide
Those who meet Class 4 with the Steinbrocker functional classification

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Central Contact	Astellas Pharma Inc	Study Chair

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
D016559	Tacrolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Chyugoku Region			Japan