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) (TREASURE)

This study is currently recruiting participants.
Verified July 2013 by Astellas Pharma Inc
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01511003
First received: January 4, 2012
Last updated: July 8, 2013
Last verified: July 2013

January 4, 2012
July 8, 2013
December 2011
June 2014   (final data collection date for primary outcome measure)
ACR20 response rate 6 months post dose [ Time Frame: Baseline and 6 months post dose ] [ Designated as safety issue: No ]
ACR20 is 20% improvement in ACR (American College of Rheumatology) core set
Same as current
Complete list of historical versions of study NCT01511003 on ClinicalTrials.gov Archive Site
  • ACR50 response rates at month 6 [ Time Frame: Baseline and at month 6 ] [ Designated as safety issue: No ]
    ACR50 is 50% improvement in ACR (American College of Rheumatology) core set
  • ACR70 response rates at month 6 [ Time Frame: Baseline and at month 6 ] [ Designated as safety issue: No ]
    ACR70 is 70% improvement in ACR (American College of Rheumatology) core set
  • Change in DAS28 from baseline to 6 months [ Time Frame: Baseline and at month 6 ] [ Designated as safety issue: No ]
    DAS (Disease Activity Score in Rheumatoid Arthritis)
  • Change in bone loss rate from baseline to 6 months [ Time Frame: Baseline and at month 6 ] [ Designated as safety issue: No ]
    comparative factors for bone loss rate: bone mineral densitometry [BMD], bone turnover marker test
  • Safety assessed by the incidence of adverse events, vital signs and lab-tests [ Time Frame: For 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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)
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

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Tacrolimus
oral
Other Name: Prograf
Experimental: Tacrolimus group
Intervention: Drug: Tacrolimus
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
June 2014
June 2014   (final data collection date for primary outcome measure)

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
  • Subjects with BMD (bone mineral densitometry) ≤ -3.0

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
Both
20 Years to 75 Years
No
Contact: Clinical Development Administration Dept. clinicaltrials_info@jp.astellas.com
Korea, Republic of
 
NCT01511003
PRGRA-10-04-KOR
No
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP