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

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	June 27, 2008
Start Date ^ICMJE	March 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00036153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study to Assess Efficacy of Tacrolimus + Methotrexate Versus Placebo + Methotrexate in Treatment of Rheumatoid Arthritis
Official Title ^ICMJE	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	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 Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: Tacrolimus (Prograf®) Drug: Methotrexate
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	210
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT ID ^ICMJE	NCT00036153
Responsible Party
Study ID Numbers ^ICMJE	01-0-103
Study Sponsor ^ICMJE	Astellas Pharma Inc
Collaborators ^ICMJE	Astellas Pharma US, Inc.
Investigators ^ICMJE
Information Provided By	Astellas Pharma Inc
Verification Date	June 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP