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A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs) (TREASURE)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tacrolimus
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring calcineurin inhibitor, Prograf, Rheumatoid arthritis (RA), Tacrolimus

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria
  • Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer
  • Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL
  • Subjects with ≥ 3 swollen joints out of 66 joints assessed
  • Subjects with ≥ 6 tender joints out of 68 joints assessed

Exclusion Criteria:

  • Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out
  • Subjects with previous experience of tacrolimus (excluding external preparations)
  • Subjects with renal dysfunction or with serum creatinin > 1.4 mg/dL at screening
  • Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening
  • Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c > 6.4% at screening
  • Subjects complicated with hyperkalemia or with serum potassium level >5.5 mEq/L at screening
  • Subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications
  • Subjects complicated with severe respiratory disease and infection
  • Subjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.)
  • Subjects who were treated with other investigational product(s) within 3 months before screening
  • Other subjects who are considered ineligible for the study by the investigator

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tacrolimus group

Arm Description

oral

Outcomes

Primary Outcome Measures

ACR20 response rate 6 months post dose
ACR20 is 20% improvement in ACR (American College of Rheumatology) core set

Secondary Outcome Measures

ACR50 response rates at month 6
ACR50 is 50% improvement in ACR (American College of Rheumatology) core set
ACR70 response rates at month 6
ACR70 is 70% improvement in ACR (American College of Rheumatology) core set
Change in DAS28 from baseline to 6 months
DAS (Disease Activity Score in Rheumatoid Arthritis)
Change in bone loss rate from baseline to 6 months
comparative factors for bone loss rate: bone mineral densitometry [BMD], bone turnover marker test
Safety assessed by the incidence of adverse events, vital signs and lab-tests

Full Information

First Posted
January 4, 2012
Last Updated
August 10, 2018
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01511003
Brief Title
A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)
Acronym
TREASURE
Official Title
An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 5, 2011 (Actual)
Primary Completion Date
May 11, 2015 (Actual)
Study Completion Date
May 11, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Korea, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
calcineurin inhibitor, Prograf, Rheumatoid arthritis (RA), Tacrolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus group
Arm Type
Experimental
Arm Description
oral
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograf
Intervention Description
oral
Primary Outcome Measure Information:
Title
ACR20 response rate 6 months post dose
Description
ACR20 is 20% improvement in ACR (American College of Rheumatology) core set
Time Frame
Baseline and 6 months post dose
Secondary Outcome Measure Information:
Title
ACR50 response rates at month 6
Description
ACR50 is 50% improvement in ACR (American College of Rheumatology) core set
Time Frame
Baseline and at month 6
Title
ACR70 response rates at month 6
Description
ACR70 is 70% improvement in ACR (American College of Rheumatology) core set
Time Frame
Baseline and at month 6
Title
Change in DAS28 from baseline to 6 months
Description
DAS (Disease Activity Score in Rheumatoid Arthritis)
Time Frame
Baseline and at month 6
Title
Change in bone loss rate from baseline to 6 months
Description
comparative factors for bone loss rate: bone mineral densitometry [BMD], bone turnover marker test
Time Frame
Baseline and at month 6
Title
Safety assessed by the incidence of adverse events, vital signs and lab-tests
Time Frame
For 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL Subjects with ≥ 3 swollen joints out of 66 joints assessed Subjects with ≥ 6 tender joints out of 68 joints assessed Exclusion Criteria: Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out Subjects with previous experience of tacrolimus (excluding external preparations) Subjects with renal dysfunction or with serum creatinin > 1.4 mg/dL at screening Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c > 6.4% at screening Subjects complicated with hyperkalemia or with serum potassium level >5.5 mEq/L at screening Subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications Subjects complicated with severe respiratory disease and infection Subjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.) Subjects who were treated with other investigational product(s) within 3 months before screening Other subjects who are considered ineligible for the study by the investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Busan
Country
Korea, Republic of
City
Daejeon
Country
Korea, Republic of
City
Gyeonggi-do
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=151
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)

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