Clinical trial NCT01511003: A Study is to Assess Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Who Showed Unsuccessful Response to Existing Disease Modifying Antirheumatic Drugs (DMARDs)
Official title: An Open- Label, Single-arm, Phase 4 Study to Assess the Efficacy and Safety of Tacrolimus in Active Rheumatoid Arthritis Patients Shown Unsuccessful Response Against DMARDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: calcineurin inhibitor
Prograf
Rheumatoid arthritis (RA)
Tacrolimus
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma Korea, Inc.
First posted: 2012-01-18
Enrollment: 128
Sex: ALL
Minimum age (years): 20
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 assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.


Eligibility criteria: Inclusion Criteria:

* Subjects who have rheumatoid arthritis for 6 months or longer based on American College of Rheumatology (ACR) diagnostic criteria
* Subjects who used more than 1 Disease Modifying Antirheumatic Drug (DMARD) including MTX (methotrexate) for 6 months or longer
* Subjects with ESR (erythrocyte sedimentation rate) ≥ 28mm/h or CRP (C-reactive protein)≥ 1.0 mg/dL
* Subjects with ≥ 3 swollen joints out of 66 joints assessed
* Subjects with ≥ 6 tender joints out of 68 joints assessed

Exclusion Criteria:

* Pregnant or nursing women, or subjects who plan to become pregnant within 6 months or whose screening test results show pregnancy cannot be ruled out
* Subjects with previous experience of tacrolimus (excluding external preparations)
* Subjects with renal dysfunction or with serum creatinin \> 1.4 mg/dL at screening
* Following subjects with hepatic dysfunction: viral infection, non-viral infection, hepatic cirrhosis, and Serum Glutamic Oxaloacetic Transaminase / Serum Glutamic Pyruvic Transaminase (SGOT/SGPT) exceeding twice the upper limit of normal at screening
* Subjects with pancreatitis, uncontrolled diabetes or complication(s) or with HbA1c \> 6.4% at screening
* Subjects complicated with hyperkalemia or with serum potassium level \>5.5 mEq/L at screening
* Subjects with history of heart disease (ischemic heart disease, arrhythmia requiring treatment, and heart failure), etc or complications
* Subjects complicated with severe respiratory disease and infection
* Subjects with history of malignant tumor or complication(s) (However, the subjects who are considered to have no risk of recurrence with malignant tumor untreated for 5 years or longer can enter the study. The subjects who succeeded in treatment for basal cell or squamous cell carcinoma of skin can also enter the study.)
* Subjects who were treated with other investigational product(s) within 3 months before screening
* Other subjects who are considered ineligible for the study by the investigator

Primary outcomes:
measure: ACR20 response rate 6 months post dose
timeFrame: Baseline and 6 months post dose
Secondary outcomes:
measure: ACR50 response rates at month 6
timeFrame: Baseline and at month 6
measure: ACR70 response rates at month 6
timeFrame: Baseline and at month 6
measure: Change in DAS28 from baseline to 6 months
timeFrame: Baseline and at month 6
measure: Change in bone loss rate from baseline to 6 months
timeFrame: Baseline and at month 6
measure: Safety assessed by the incidence of adverse events, vital signs and lab-tests
timeFrame: For 6 months
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gyeonggi-do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References: