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

This study has been completed.

Sponsor:

Collaborator:

Astellas Pharma US, Inc.

Information provided by:

Astellas Pharma Inc

ClinicalTrials.gov Identifier:

NCT00036153

First received: May 8, 2002

Last updated: March 26, 2012

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 8, 2002
Last Updated Date	March 26, 2012
Start Date ^ICMJE	March 2002
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00036153 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

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 Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Condition ^ICMJE	Rheumatoid Arthritis
Intervention ^ICMJE	Drug: Tacrolimus (Prograf®) Drug: Methotrexate
Study Arm (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	210
Completion Date	January 2004
Primary Completion Date	Not Provided
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 Number ^ICMJE	NCT00036153
Other Study ID Numbers ^ICMJE	01-0-103
Has Data Monitoring Committee	Not Provided
Responsible Party	Not Provided
Study Sponsor ^ICMJE	Astellas Pharma Inc
Collaborators ^ICMJE	Astellas Pharma US, Inc.
Investigators ^ICMJE	Not Provided
Information Provided By	Astellas Pharma Inc
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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