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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Astellas Pharma Inc
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01511003
First received: January 4, 2012
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • ACR20 response rate 6 months post dose [ Time Frame: Baseline and 6 months post dose ] [ Designated as safety issue: No ]
    ACR20 is 20% improvement in ACR (American College of Rheumatology) core set


Secondary Outcome Measures:
  • ACR50 response rates at month 6 [ Time Frame: Baseline and at month 6 ] [ Designated as safety issue: No ]
    ACR50 is 50% improvement in ACR (American College of Rheumatology) core set

  • ACR70 response rates at month 6 [ Time Frame: Baseline and at month 6 ] [ Designated as safety issue: No ]
    ACR70 is 70% improvement in ACR (American College of Rheumatology) core set

  • Change in DAS28 from baseline to 6 months [ Time Frame: Baseline and at month 6 ] [ Designated as safety issue: No ]
    DAS (Disease Activity Score in Rheumatoid Arthritis)

  • Change in bone loss rate from baseline to 6 months [ Time Frame: Baseline and at month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: For 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 96
Study Start Date: December 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus group Drug: Tacrolimus
oral
Other Name: Prograf

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511003

Contacts
Contact: Clinical Development Administration Dept. clinicaltrials_info@jp.astellas.com

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

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01511003     History of Changes
Other Study ID Numbers: PRGRA-10-04-KOR
Study First Received: January 4, 2012
Last Updated: July 8, 2013
Health Authority: Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Tacrolimus
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 21, 2014