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

This study has been completed.
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc Identifier:
First received: October 18, 2010
Last updated: December 28, 2015
Last verified: December 2015
This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.

Condition Intervention Phase
Rheumatoid Arthritis
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • ACR20 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ]
    ACR20: 20% Improvement in American College of Rheumatology Core Set

Secondary Outcome Measures:
  • ACR50 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ]
  • ACR70 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ]
  • Changes from baseline in 100mm pain VAS (Visual Analogue Scale) [ Time Frame: Baseline and up to 6 months ]
  • Changes from baseline in DAS 28 response rate [ Time Frame: Baseline and up to 6 months ]
  • Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test [ Time Frame: For 6 months ]

Enrollment: 78
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus group Drug: Tacrolimus
Other Names:
  • Prograf
  • FK506


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01224041

Korea, Republic of
Busan, Korea, Republic of
Daegu, Korea, Republic of
Gwangju, Korea, Republic of
Jeonju, Korea, Republic of
Jinju, Korea, Republic of
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01224041     History of Changes
Other Study ID Numbers: PRGRA-09-02-KOR
Study First Received: October 18, 2010
Last Updated: December 28, 2015
Individual Participant Data  
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Antimetabolites, Antineoplastic
Antineoplastic Agents
Dermatologic Agents
Folic Acid Antagonists
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors processed this record on May 25, 2017