Special Drug Use-Results Survey of Prograf Capsule in Rhe... | NCT01870908

Studies
Special Drug Use-Results Survey of Prograf Capsule in Rheumatoid Arthritis Patients

NCT01870908

Sponsor

Astellas Pharma Inc

Status

Completed

Last Update Posted

Oct 5, 2015Estimated

Enrollment

664Actual

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

tacrolimus
biological agents

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

Oct 2015

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

Aug 2012

Primary Completion Date

Mar 2015Actual

Completion Date

Mar 2015Actual

First Submitted Date

Jun 4, 2013

First Submission Date that Met QC Criteria

Jun 4, 2013

First Posted Date

Jun 6, 2013Estimated

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

Oct 2, 2015

Last Update Posted Date

Oct 5, 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

This study is to evaluate the safety and the effectiveness of treatment with tacrolimus and biological agents.

Detailed Description

The purpose of this study is to confirm the safety of 24 weeks-treatment with the combination of tacrolimus + biological agents, and to assess the efficacy using SDAI, CDAI, DAS28-CRP, MMP-3, MHAQ in patients with rheumatoid arthritis who have not achieved SDAI remission despite of using biological agents for over 8 weeks.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

664Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
tacrolimus + biological agents			Drug: tacrolimus Drug: biological agents

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tacrolimus	Drug		tacrolimus + biological agents	prograf
biological agents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Simplified disease activity index (SDAI)		Baseline and week-24

Secondary Outcomes

Measure	Description	Time Frame
Clinical disease activity index (CDAI)		Baseline, week-12 and week-24
Disease Activity Score 28 (DAS28)		Baseline, week-12 and week-24

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with rheumatoid arthritis who have been treated with biological agents over 8 weeks but have not achieved SDAI remission (SDAI < 3.3)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with rheumatoid arthritis who have been treated with biological agents

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Use Central Contact	Astellas Pharma Inc	Study Director

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
D001685	Biological Factors

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
		Chūbu			Japan