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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00036153

Public ClinicalTrials.gov record NCT00036153. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 13, 2026, 2:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00036153
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Astellas Pharma Inc
Industry
Enrollment
210 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 28, 2002
Primary completion
Not listed
Completion
Dec 31, 2003
Last update posted
Mar 26, 2012

2002 – 2004

United States locations

U.S. sites
42
U.S. states
19
U.S. cities
39
Facility City State ZIP Site status
University of Alabama at Birmingham Birmingham Alabama 35249
Rheumatology Associates of North Alabama Huntsville Alabama 35801
Radiant Research, Pharmaceutical Clinical Trials Division Scottsdale Arizona 85251
Boling Clinical Trials Rancho Cucamonga California 91730
San Diego Arthritis & Osteoporosis Medical Clinic San Diego California 92120
Pacific Arthritis Center and Medical Group Santa Maria California 93454
Arthritis Associates of CT Danbury Connecticut 06810
Stamford Therapeutic Consortium Stamford Connecticut 06905
Center of Rheumatology, Immunology & Arthritis Fort Lauderdale Florida 33334
Arthritis Center Palm Harbor Florida 34684
Sarasota Arthritis Center, Rheumatology Division Sarasota Florida 34239
Arthritis & Rheumatology Associates of Palm Beach West Palm Beach Florida 33401
Coeur d'Alene Arthritis Clinic Coeur d'Alene Idaho 83814
Northwestern Center for Clinical Research Chicago Illinois 60611
Decatur Memorial Hospital Decatur Illinois 62526
Illinois Bone & Joint Institute Morton Grove Illinois 60053
Rockford Clinical Rockford Illinois 61103
The Arthritis Center Springfield Illinois 62704
Arthritis & Osteoporosis Center of Maryland Frederick Maryland 21702
Phase III Clinical Research Fall River Massachusetts 02720
Midwest Arthritis Center Kalamazoo Michigan 49048
Washington University School of Medicine St Louis Missouri 63110
St. Louis Center for Clinical Research St Louis Missouri 63128
Arthritis Consultants St Louis Missouri 63141
Arthritis Regional Research Center Mercerville New Jersey 08619
New Jersey Physicians, LLC Passaic New Jersey 07055
North Carolina Arthritis & Allergy Care Center Raleigh North Carolina 27609
Radiant Research - Columbus Columbus Ohio 43212
STAT Research, Inc. Dayton Ohio 45402
PRO Research Eugene Oregon 97401
Oregon Health Sciences Center Portland Oregon 97201
Portland Medical Associates, P.C. Portland Oregon 97224
Altoona Center for Clinical Research Duncansville Pennsylvania 16635
Center for Assessment & Research of Erie Erie Pennsylvania 16508
Central Pennsylvania Clinical Research Mechanicsburg Pennsylvania 17055
Clinical Research Center of Reading, LLP West Reading Pennsylvania 19611
Rheumatic Disease Associates Willow Grove Pennsylvania 19090
Radiant Research - Dallas Dallas Texas 75235
San Antonio Center for Clinical Research San Antonio Texas 78229
Physicians Research Options, L.C. Sandy City Utah 84070
Metropolitan Clinical Research Falls Church Virginia 22044
Lewis-Gale Clinic Salem Virginia 24153

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00036153, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 26, 2012 · Synced Sep 13, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00036153 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →