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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01511003
Recruitment Status : Completed
First Posted : January 18, 2012
Last Update Posted : July 19, 2017
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Tacrolimus Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 5, 2011
Actual Primary Completion Date : May 11, 2015
Actual Study Completion Date : May 11, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Tacrolimus group
Drug: Tacrolimus
Other Name: Prograf

Primary Outcome Measures :
  1. ACR20 response rate 6 months post dose [ Time Frame: Baseline and 6 months post dose ]
    ACR20 is 20% improvement in ACR (American College of Rheumatology) core set

Secondary Outcome Measures :
  1. ACR50 response rates at month 6 [ Time Frame: Baseline and at month 6 ]
    ACR50 is 50% improvement in ACR (American College of Rheumatology) core set

  2. ACR70 response rates at month 6 [ Time Frame: Baseline and at month 6 ]
    ACR70 is 70% improvement in ACR (American College of Rheumatology) core set

  3. Change in DAS28 from baseline to 6 months [ Time Frame: Baseline and at month 6 ]
    DAS (Disease Activity Score in Rheumatoid Arthritis)

  4. Change in bone loss rate from baseline to 6 months [ Time Frame: Baseline and at month 6 ]
    comparative factors for bone loss rate: bone mineral densitometry [BMD], bone turnover marker test

  5. Safety assessed by the incidence of adverse events, vital signs and lab-tests [ Time Frame: For 6 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  • Subjects with BMD (bone mineral densitometry) ≤ -3.0

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01511003

Korea, Republic of
Busan, Korea, Republic of
Daejeon, Korea, Republic of
Gyeonggi-do, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01511003     History of Changes
Other Study ID Numbers: PRGRA-10-04-KOR
First Posted: January 18, 2012    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Astellas Pharma Inc:
calcineurin inhibitor
Rheumatoid arthritis (RA)

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action