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Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

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 Tacrolimus, Prograf, Calcinurin inhibitor, Rheumatoid arthritis (RA)

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria
  • Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator
  • ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein)
  • Patients are required to have at least 3 of 66 joints assessed as swollen
  • Patients are required to have at least 6 of 68 joints assessed as painful with pressure

Exclusion Criteria:

  • Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study
  • Previous experience of tacrolimus (ointment excluded)
  • Renal impairment or serum creatinine > 1.4 mg/dL
  • Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT > 2x upper limit normal
  • Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level >110mg/dl before the meal and >200mg/dl after the meal HbA1c > 6.4%
  • Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications
  • Other investigational drug within last 30 days
  • Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tacrolimus group

Arm Description

Outcomes

Primary Outcome Measures

ACR20 response rate compared to baseline
ACR20: 20% Improvement in American College of Rheumatology Core Set

Secondary Outcome Measures

ACR50 response rate compared to baseline
ACR70 response rate compared to baseline
Changes from baseline in 100mm pain VAS (Visual Analogue Scale)
Changes from baseline in DAS 28 response rate
Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test

Full Information

First Posted
October 18, 2010
Last Updated
December 28, 2015
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma Korea, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01224041
Brief Title
Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
Official Title
Clinical Study to Evaluate the Efficacy of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against Methotrexate: Non-comparative, Single Arm, Multi-center, Phase 4 Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (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 evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.

6. Conditions and Keywords

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Tacrolimus group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Other Intervention Name(s)
Prograf, FK506
Intervention Description
oral
Primary Outcome Measure Information:
Title
ACR20 response rate compared to baseline
Description
ACR20: 20% Improvement in American College of Rheumatology Core Set
Time Frame
Baseline and up to 6 months
Secondary Outcome Measure Information:
Title
ACR50 response rate compared to baseline
Time Frame
Baseline and up to 6 months
Title
ACR70 response rate compared to baseline
Time Frame
Baseline and up to 6 months
Title
Changes from baseline in 100mm pain VAS (Visual Analogue Scale)
Time Frame
Baseline and up to 6 months
Title
Changes from baseline in DAS 28 response rate
Time Frame
Baseline and up to 6 months
Title
Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test
Time Frame
For 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with more than 6 months history of rheumatoid arthritis according to ACR criteria Patients who have been treated unsuccessfully to more than single DMARDs including methotrexate at the discretion of investigator ESR ≥ 30 mm/h or CRP ≥ 1.0 mg/dL (ESR: Erythrocyte Sedimentation Rate, CRP: C-Reactive Protein) Patients are required to have at least 3 of 66 joints assessed as swollen Patients are required to have at least 6 of 68 joints assessed as painful with pressure Exclusion Criteria: Pregnant or breast-feeding patients. Patients who plan to bear children or breast-feed during the study and within 6 month after completion of study Previous experience of tacrolimus (ointment excluded) Renal impairment or serum creatinine > 1.4 mg/dL Liver function failure as follows: viral hepatitis, non-viral hepatitis, cirrhosis, SGOT/SGPT > 2x upper limit normal Patients with history of pancreatitis, glucose intolerance or complication or who indicates any of the following criteria:Blood glucose level >110mg/dl before the meal and >200mg/dl after the meal HbA1c > 6.4% Cardiac disease(ischemic heart disease, treatment-requiring arrhythmia, heart failure)or complications Other investigational drug within last 30 days Patients who have been treated with infliximab, adalimumab, or leflunomide within 8 weeks of start of the study
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
Daegu
Country
Korea, Republic of
City
Gwangju
Country
Korea, Republic of
City
Jeonju
Country
Korea, Republic of
City
Jinju
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Links:
URL
https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=PRGRA-09-02-KOR
Description
Link to results on Astellas Clinical Study Results Web site

Learn more about this trial

Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate

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