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

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: NCT01224041
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : December 29, 2015
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2009
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tacrolimus group Drug: Tacrolimus
Other Names:
  • Prograf
  • FK506

Primary Outcome Measures :
  1. 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 :
  1. ACR50 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ]
  2. ACR70 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ]
  3. Changes from baseline in 100mm pain VAS (Visual Analogue Scale) [ Time Frame: Baseline and up to 6 months ]
  4. Changes from baseline in DAS 28 response rate [ Time Frame: Baseline and up to 6 months ]
  5. Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test [ 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.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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): NCT01224041

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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.
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Study Chair: Use Central Contact Astellas Pharma Inc

Additional Information:
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Responsible Party: Astellas Pharma Inc Identifier: NCT01224041    
Other Study ID Numbers: PRGRA-09-02-KOR
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: December 29, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Astellas Pharma Inc:
Calcinurin inhibitor
Rheumatoid arthritis (RA)
Additional relevant MeSH terms:
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Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Calcineurin Inhibitors