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)

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

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

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Tacrolimus

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Gyeonggi-do, Korea, Republic of
  • Seoul, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tacrolimus group; oral	Drug: Tacrolimus; oral; Other Names: Prograf

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR20 response rate 6 months post dose	ACR20 is 20% improvement in ACR (American College of Rheumatology) core set	Baseline and 6 months post dose

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Collaborators: Astellas Pharma Korea, Inc.

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2011
• Primary Completion (Actual): May 11, 2015
• Study Completion (Actual): May 11, 2015

Study Registration Dates

• First Submitted: January 4, 2012
• First Submitted That Met QC Criteria: January 12, 2012
• First Posted (Estimate): January 18, 2012

Study Record Updates

• Last Update Posted (Actual): August 13, 2018
• Last Update Submitted That Met QC Criteria: August 10, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Tacrolimus; Prograf; calcineurin inhibitor; Rheumatoid arthritis (RA)
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: PRGRA-10-04-KOR