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)

Rheumatoid Arthritis Clinical Trial

— TREASURE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01511003
• Other study ID #: PRGRA-10-04-KOR
• Status: Completed
• Phase: Phase 4
• Start date: December 5, 2011
• Est. completion date: May 11, 2015

Study information

• Verified date: August 2018
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to assess efficacy and safety of tacrolimus in active rheumatoid arthritis patients who showed unsuccessful response to existing DMARDs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 11, 2015
• Est. primary completion date: May 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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

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 6 months post dose	ACR20 is 20% improvement in ACR (American College of Rheumatology) core set	Baseline and 6 months post dose
Secondary	ACR50 response rates at month 6	ACR50 is 50% improvement in ACR (American College of Rheumatology) core set	Baseline and at month 6
Secondary	ACR70 response rates at month 6	ACR70 is 70% improvement in ACR (American College of Rheumatology) core set	Baseline and at month 6
Secondary	Change in DAS28 from baseline to 6 months	DAS (Disease Activity Score in Rheumatoid Arthritis)	Baseline and at month 6
Secondary	Change in bone loss rate from baseline to 6 months	comparative factors for bone loss rate: bone mineral densitometry [BMD], bone turnover marker test	Baseline and at month 6
Secondary	Safety assessed by the incidence of adverse events, vital signs and lab-tests		For 6 months

External Links

•   Link to results on Astellas Clinical Study Results website