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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.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01224041
First received: October 18, 2010
Last updated: October 6, 2011
Last verified: October 2011
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • ACR70 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline in 100mm pain VAS (Visual Analogue Scale) [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline in DAS 28 response rate [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test [ Time Frame: For 6 months ] [ Designated as safety issue: No ]

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
oral
Other Names:
  • Prograf
  • FK506

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224041

Locations
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.
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01224041     History of Changes
Other Study ID Numbers: PRGRA-09-02-KOR
Study First Received: October 18, 2010
Last Updated: October 6, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
Tacrolimus
Prograf
Calcinurin 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
Methotrexate
Tacrolimus
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013