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

October 19, 2010 updated by: Astellas Pharma Inc

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

This study is to evaluate efficacy of 6 months treatment of tacrolimus in active Rheumatoid Arthritis patients who showed unsuccessful response against methotrexate.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tacrolimus group
oral
Other Names:
  • Prograf
  • FK506

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR20 response rate compared to baseline
Time Frame: Baseline and up to 6 months
(ACR20: 20% improvement in American College of Rheumatology Core Set)
Baseline and up to 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
ACR50 response rate compared to baseline
Time Frame: Baseline and up to 6 months
Baseline and up to 6 months
ACR70 response rate compared to baseline
Time Frame: Baseline and up to 6 months
Baseline and up to 6 months
Changes from baseline in 100mm pain VAS (Visual Analogue Scale)
Time Frame: Baseline and up to 6 months
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
For 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

October 14, 2010

First Submitted That Met QC Criteria

October 19, 2010

First Posted (Estimate)

October 20, 2010

Study Record Updates

Last Update Posted (Estimate)

October 20, 2010

Last Update Submitted That Met QC Criteria

October 19, 2010

Last Verified

October 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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