Clinical trial NCT01224041: Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Tacrolimus
Prograf
Calcinurin inhibitor
Rheumatoid arthritis (RA)
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2010-10-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: ACR20 response rate compared to baseline
timeFrame: Baseline and up to 6 months
Secondary outcomes:
measure: ACR50 response rate compared to baseline
timeFrame: Baseline and up to 6 months
measure: ACR70 response rate compared to baseline
timeFrame: Baseline and up to 6 months
measure: Changes from baseline in 100mm pain VAS (Visual Analogue Scale)
timeFrame: Baseline and up to 6 months
measure: Changes from baseline in DAS 28 response rate
timeFrame: Baseline and up to 6 months
measure: Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test
timeFrame: For 6 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Gwangju
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Jinju
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: