Rheumatoid ArthritisPhase 3NCT00036153
Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
A Phase 3 study testing Tacrolimus (Prograf®) and Methotrexate in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 45 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tacrolimus (Prograf®) and Methotrexate
- How many people
- 210 participants
- Where
- 45 sitesin 2 countries
- Study dates
- Mar 2002to Jan 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
45 sites in 2 countries.
45 sites in 2 countries
United States42 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35249
Northwestern Center for Clinical Research
Chicago, Illinois, 60611
Coeur d'Alene Arthritis Clinic
Coeur d'Alene, Idaho, 83814
Radiant Research - Columbus
Columbus, Ohio, 43212
Radiant Research - Dallas
Dallas, Texas, 75235
Arthritis Associates of CT
Danbury, Connecticut, 06810
STAT Research, Inc.
Dayton, Ohio, 45402
Decatur Memorial Hospital
Decatur, Illinois, 62526
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Center for Assessment & Research of Erie
Erie, Pennsylvania, 16508
PRO Research
Eugene, Oregon, 97401
Phase III Clinical Research
Fall River, Massachusetts, 02720
Metropolitan Clinical Research
Falls Church, Virginia, 22044
Center of Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida, 33334
Arthritis & Osteoporosis Center of Maryland
Frederick, Maryland, 21702
Rheumatology Associates of North Alabama
Huntsville, Alabama, 35801
Midwest Arthritis Center
Kalamazoo, Michigan, 49048
Central Pennsylvania Clinical Research
Mechanicsburg, Pennsylvania, 17055
Arthritis Regional Research Center
Mercerville, New Jersey, 08619
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053
Arthritis Center
Palm Harbor, Florida, 34684
New Jersey Physicians, LLC
Passaic, New Jersey, 07055
Oregon Health Sciences Center
Portland, Oregon, 97201
Portland Medical Associates, P.C.
Portland, Oregon, 97224
North Carolina Arthritis & Allergy Care Center
Raleigh, North Carolina, 27609
Boling Clinical Trials
Rancho Cucamonga, California, 91730
Rockford Clinical
Rockford, Illinois, 61103
Lewis-Gale Clinic
Salem, Virginia, 24153
San Antonio Center for Clinical Research
San Antonio, Texas, 78229
San Diego Arthritis & Osteoporosis Medical Clinic
San Diego, California, 92120
Physicians Research Options, L.C.
Sandy City, Utah, 84070
Pacific Arthritis Center and Medical Group
Santa Maria, California, 93454
Sarasota Arthritis Center, Rheumatology Division
Sarasota, Florida, 34239
Radiant Research, Pharmaceutical Clinical Trials Division
Scottsdale, Arizona, 85251
The Arthritis Center
Springfield, Illinois, 62704
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
Stamford Therapeutic Consortium
Stamford, Connecticut, 06905
Arthritis & Rheumatology Associates of Palm Beach
West Palm Beach, Florida, 33401
Clinical Research Center of Reading, LLP
West Reading, Pennsylvania, 19611
Rheumatic Disease Associates
Willow Grove, Pennsylvania, 19090
Canada3 sites
Doctor's Office
Hamilton, Ontario, L8N 1Y2
Doctor's Office
Hamilton, Ontario, L8N 2B6
The Arthritis Program Research Group, Inc.
Newmarket, Ontario, L3Y 3R7
About this study
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
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tacrolimus (Prograf®), Methotrexate
- Keywords
- Tacrolimus, Prograf®, FK506
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tacrolimus (Prograf®)Drug
MethotrexateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study startMar 2002
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 210 participants
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036153
- Sponsor's protocol ID
- 01-0-103
- Status last verified
- Dec 2011
- First submitted
- 8 May 2002
- Last updated
- 27 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00036153
- Acronym / sponsor ID
- 01-0-103
- Conditions
- Rheumatoid Arthritis
- Keywords
- Tacrolimus, Prograf®, FK506
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Astellas Pharma US, Inc.
- Study start
- Mar 2002
- Study completion
- Jan 2004 (actual)
- First posted
- 9 May 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tacrolimus (Prograf®) | Drug | – |
| Methotrexate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
45 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tacrolimus (Prograf®) and Methotrexate in people with Rheumatoid Arthritis, run by Astellas Pharma Inc at 45 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2012.