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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224418
• Other study ID #: PRGRA-08-01-KOR
• Status: Completed
• Phase: Phase 4
• First received: October 14, 2010
• Last updated: October 19, 2010
• Start date: May 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2010
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Tacrolimus
oral

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma Korea, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 response rate compared to baseline	(ACR20: 20% improvement in American College of Rheumatology Core Set)	Baseline and up to 6 months	No
Secondary	ACR50 response rate compared to baseline		Baseline and up to 6 months	No
Secondary	ACR70 response rate compared to baseline		Baseline and up to 6 months	No
Secondary	Changes from baseline in 100mm pain VAS (Visual Analogue Scale)		Baseline and up to 6 months	No
Secondary	Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test		For 6 months	No