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Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tacrolimus (Prograf®)
Methotrexate
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Tacrolimus, Prograf®, FK506

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria Willing to discontinue DMARDs, other than methotrexate Has a diagnosis of Rheumatoid Arthritis using American College of Rheumatology Criteria, of at least 6 months duration Have been receiving oral or parenteral methotrexate for at least 3 months Exclusion Criteria Has received tacrolimus for any indication Has moderate or severe liver disease Has a known history of HIV infection Has serum creatinine outside the normal range

Sites / Locations

  • University of Alabama at Birmingham
  • Rheumatology Associates of North Alabama
  • Radiant Research, Pharmaceutical Clinical Trials Division
  • Boling Clinical Trials
  • San Diego Arthritis & Osteoporosis Medical Clinic
  • Pacific Arthritis Center and Medical Group
  • Arthritis Associates of CT
  • Stamford Therapeutic Consortium
  • Center of Rheumatology, Immunology & Arthritis
  • Arthritis Center
  • Sarasota Arthritis Center, Rheumatology Division
  • Arthritis & Rheumatology Associates of Palm Beach
  • Coeur d'Alene Arthritis Clinic
  • Northwestern Center for Clinical Research
  • Decatur Memorial Hospital
  • Illinois Bone & Joint Institute
  • Rockford Clinical
  • The Arthritis Center
  • Arthritis & Osteoporosis Center of Maryland
  • Phase III Clinical Research
  • Midwest Arthritis Center
  • Washington University School of Medicine
  • St. Louis Center for Clinical Research
  • Arthritis Consultants
  • Arthritis Regional Research Center
  • New Jersey Physicians, LLC
  • North Carolina Arthritis & Allergy Care Center
  • Radiant Research - Columbus
  • STAT Research, Inc.
  • PRO Research
  • Oregon Health Sciences Center
  • Portland Medical Associates, P.C.
  • Altoona Center for Clinical Research
  • Center for Assessment & Research of Erie
  • Central Pennsylvania Clinical Research
  • Clinical Research Center of Reading, LLP
  • Rheumatic Disease Associates
  • Radiant Research - Dallas
  • San Antonio Center for Clinical Research
  • Physicians Research Options, L.C.
  • Metropolitan Clinical Research
  • Lewis-Gale Clinic
  • Doctor's Office
  • Doctor's Office
  • The Arthritis Program Research Group, Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
May 8, 2002
Last Updated
March 26, 2012
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00036153
Brief Title
Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
Official Title
A Randomized, Double-Blind Study to Assess the Efficacy of Tacrolimus (Prograf®)+ Methotrexate Vs. Placebo + Methotrexate in the Treatment of Rheumatoid Arthritis in Patients With Partial Response to Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of the combination of tacrolimus + methotrexate compared to methotrexate alone in the treatment of the signs and symptoms of rheumatoid arthritis over 6 months in patients with partial response to methotrexate.
Detailed Description
This is a Phase III, 6 month randomized, double-blind, placebo controlled multi-center study with a 6 month open-label extension. Patients will be randomized to the tacrolimus + methotrexate arm or the placebo + methotrexate arm in a ratio of 2:1. Patients who complete the 6-month double-blind phase will be eligible to enroll in the open-label phase of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Tacrolimus, Prograf®, FK506

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
210 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tacrolimus (Prograf®)
Intervention Type
Drug
Intervention Name(s)
Methotrexate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Willing to discontinue DMARDs, other than methotrexate Has a diagnosis of Rheumatoid Arthritis using American College of Rheumatology Criteria, of at least 6 months duration Have been receiving oral or parenteral methotrexate for at least 3 months Exclusion Criteria Has received tacrolimus for any indication Has moderate or severe liver disease Has a known history of HIV infection Has serum creatinine outside the normal range
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Rheumatology Associates of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Radiant Research, Pharmaceutical Clinical Trials Division
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Boling Clinical Trials
City
Rancho Cucamonga
State/Province
California
ZIP/Postal Code
91730
Country
United States
Facility Name
San Diego Arthritis & Osteoporosis Medical Clinic
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Pacific Arthritis Center and Medical Group
City
Santa Maria
State/Province
California
ZIP/Postal Code
93454
Country
United States
Facility Name
Arthritis Associates of CT
City
Danbury
State/Province
Connecticut
ZIP/Postal Code
06810
Country
United States
Facility Name
Stamford Therapeutic Consortium
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Center of Rheumatology, Immunology & Arthritis
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33334
Country
United States
Facility Name
Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
Sarasota Arthritis Center, Rheumatology Division
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Arthritis & Rheumatology Associates of Palm Beach
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Facility Name
Coeur d'Alene Arthritis Clinic
City
Coeur D'Alene
State/Province
Idaho
ZIP/Postal Code
83814
Country
United States
Facility Name
Northwestern Center for Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Illinois Bone & Joint Institute
City
Morton Grove
State/Province
Illinois
ZIP/Postal Code
60053
Country
United States
Facility Name
Rockford Clinical
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61103
Country
United States
Facility Name
The Arthritis Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Arthritis & Osteoporosis Center of Maryland
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
Phase III Clinical Research
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Midwest Arthritis Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
St. Louis Center for Clinical Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Arthritis Consultants
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Arthritis Regional Research Center
City
Mercerville
State/Province
New Jersey
ZIP/Postal Code
08619
Country
United States
Facility Name
New Jersey Physicians, LLC
City
Passaic
State/Province
New Jersey
ZIP/Postal Code
07055
Country
United States
Facility Name
North Carolina Arthritis & Allergy Care Center
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Radiant Research - Columbus
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
STAT Research, Inc.
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45402
Country
United States
Facility Name
PRO Research
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Oregon Health Sciences Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97201
Country
United States
Facility Name
Portland Medical Associates, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97224
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Center for Assessment & Research of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16508
Country
United States
Facility Name
Central Pennsylvania Clinical Research
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
Clinical Research Center of Reading, LLP
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Rheumatic Disease Associates
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Radiant Research - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
San Antonio Center for Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Physicians Research Options, L.C.
City
Sandy
State/Province
Utah
ZIP/Postal Code
84070
Country
United States
Facility Name
Metropolitan Clinical Research
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22044
Country
United States
Facility Name
Lewis-Gale Clinic
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Doctor's Office
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 1Y2
Country
Canada
Facility Name
Doctor's Office
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 2B6
Country
Canada
Facility Name
The Arthritis Program Research Group, Inc.
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 3R7
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://www.clinicaltrials.jp/user/ctrDetail_e.jsp?resultId=344
Description
Link to results on JAPIC

Learn more about this trial

Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis

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