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

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01224041
First received: October 18, 2010
Last updated: October 6, 2011
Last verified: October 2011

October 18, 2010
October 6, 2011
August 2009
June 2011   (final data collection date for primary outcome measure)
ACR20 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
ACR20: 20% Improvement in American College of Rheumatology Core Set
Same as current
Complete list of historical versions of study NCT01224041 on ClinicalTrials.gov Archive Site
  • ACR50 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • ACR70 response rate compared to baseline [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline in 100mm pain VAS (Visual Analogue Scale) [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • Changes from baseline in DAS 28 response rate [ Time Frame: Baseline and up to 6 months ] [ Designated as safety issue: No ]
  • Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test [ Time Frame: For 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Efficacy of Tacrolimus in Rheumatoid Arthritis Patients Shown Unsuccessful Response to Methotrexate
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

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

Not Provided
Interventional
Phase 4
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Tacrolimus
oral
Other Names:
  • Prograf
  • FK506
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.
 
Completed
78
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01224041
PRGRA-09-02-KOR
No
Astellas Pharma Inc
Astellas Pharma Inc
Astellas Pharma Korea, Inc.
Study Chair: Use Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2011

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