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)

NCT01511003 | Completed Phase 4

• 1 other identifier: PRGRA-10-04-KOR
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Rheumatoid Arthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• ACR50 response rates at month 6

  Baseline and at month 6

• ACR70 response rates at month 6

  Baseline and at month 6

• Change in DAS28 from baseline to 6 months

  Baseline and at month 6

• Change in bone loss rate from baseline to 6 months

  Baseline and at month 6

• Safety assessed by the incidence of adverse events, vital signs and lab-tests

  For 6 months

Study Arms (1)

Tacrolimus group

EXPERIMENTAL

oral

Drug: Tacrolimus

Interventions

Tacrolimus DRUG

oral

Also known as: Prograf

Tacrolimus group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (4)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Links

• Link to results on Astellas Clinical Study Results website

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: January 4, 2012
• First Posted: January 18, 2012
• Study Start: December 5, 2011
• Primary Completion: May 11, 2015
• Study Completion: May 11, 2015
• Last Updated: August 13, 2018

Record last verified: 2018-08

Locations

KR (4)