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

NCT01224041 | Completed Phase 4

• 1 other identifier: PRGRA-09-02-KOR
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 5

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 (5)

• 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

• Changes from baseline in DAS 28 response rate

  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 (5)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Jinju, South Korea

Location

Related Links

• Link to results on Astellas Clinical Study Results Web site

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2010
• First Posted: October 19, 2010
• Study Start: August 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

KR (5)