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

NCT01224418 | Completed Phase 4

• 1 other identifier: PRGRA-08-01-KOR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Rheumatoid Arthritis

Keywords

Tacrolimus; Prograf; Calcinurin inhibitor; Rheumatoid arthritis(RA)

Outcome Measures

Primary Outcomes (1)

• ACR20 response rate compared to baseline

  (ACR20: 20% improvement in American College of Rheumatology Core Set)

  Baseline and up to 6 months

Secondary Outcomes (4)

• ACR50 response rate compared to baseline

  Baseline and up to 6 months

• ACR70 response rate compared to baseline

  Baseline and up to 6 months

• Changes from baseline in 100mm pain VAS (Visual Analogue Scale)

  Baseline and up to 6 months

• Safety assessed by the incidence of adverse event and abnormalities in clinical laboratory test

  For 6 months

Study Arms (1)

Tacrolimus group

EXPERIMENTAL

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

oral

Also known as: Prograf, FK506

Tacrolimus group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead
• Astellas Pharma Korea, Inc.: collaborator

Study Sites (2)

Unknown Facility

Gyeonggido, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 20, 2010
• Study Start: May 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: October 20, 2010

Record last verified: 2010-10

Locations

KR (2)