NCT00319917

Brief Summary

The purpose of the study is to assess the efficacy on joint damage and safety in RA patients treated with DMARDs in a double blind, placebo controlled study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Apr 2006

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2006

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2006

Completed
Same day until next milestone

First Posted

Study publicly available on registry

April 27, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

August 21, 2014

Status Verified

August 1, 2014

Enrollment Period

2.5 years

First QC Date

April 27, 2006

Last Update Submit

August 19, 2014

Conditions

Rheumatoid Arthritis

Keywords

TacrolimusRheumatoid ArthritisTacrolimus anhydrous

Outcome Measures

Primary Outcomes (1)

  • Radiographic progression of structural joint damage

    52 Weeks

Secondary Outcomes (1)

  • Signs and symptoms of rheumatoid arthritis

    52 Weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: tacrolimus

2

PLACEBO COMPARATOR
Drug: placebo

Interventions

tacrolimusDRUG

oral

Also known as: Prograf, FK506
1
placeboDRUG

oral

2

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinically diagnosed as rheumatoid arthritis by the revised ACR criteria
  • Those who have been treated with an adequate stable dose of either methotrexate, salazosulfapyridine or bucillamine
  • Those who have at least one erosion on X-ray of hands, wrists or feet

You may not qualify if:

  • Those who have been treated with any biologic drugs or leflunomide
  • Those who meet Class 4 with the Steinbrocker functional classification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Chyugoku Region, Japan

Location

Unknown Facility

Hokkaido Region, Japan

Location

Unknown Facility

Hokuriku Region, Japan

Location

Unknown Facility

Kansai Region, Japan

Location

Unknown Facility

Kanto Region, Japan

Location

Unknown Facility

Kyushu Region, Japan

Location

Unknown Facility

Shin-etsu Region, Japan

Location

Unknown Facility

Tohoku Region, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 27, 2006

First Posted

April 27, 2006

Study Start

April 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

August 21, 2014

Record last verified: 2014-08

Locations

JP(8)