Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00445770

Purpose

The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: Etanercept Drug: Methotrexate	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Multicenter, Comparative Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Active Rheumatoid Arthritis

Further study details as provided by Wyeth:

Primary Outcome Measures:

Based on the radiographic endpoint, change in modified Total Sharp Score from baseline to 52 weeks. [ Time Frame: 52 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of all AEs during the study will be compared between treatment groups. [ Time Frame: 52 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	540
Study Start Date:	June 2006
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Etanercept 10 or 25 mg, twice weekly, subcutaneous injection for 52 weeks
2: Experimental	Drug: Etanercept 10 or 25 mg, twice weekly, subcutaneous injection for 52 weeks
3: Active Comparator	Drug: Methotrexate up to 8 mg per week, oral dosing for 52 weeks

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Must be Japanese and live in Japan
Must be age 20 to 75 years
Diagnosed less than or equal to 5 years from time of first visit

Exclusion Criteria:

Anyone who has received etanercept or TNF-inhibitors such as infliximab, humeria, or adalimumab in the past
Patient with other rheumatic diseases or conditions that could predispose the patient to infection
Pregnant or lactating women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445770

Contacts

Contact: Trial Manager

clinicaltrialparticipation@wyeth.com

Locations

Japan
	Recruiting
Kato city Fujita letter Higashiyama, Japan, 944-25

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A1-315
Study First Received:	March 8, 2007
Last Updated:	December 19, 2007
ClinicalTrials.gov Identifier:	NCT00445770
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth:

Rheumatoid Arthritis
Arthritis

Study placed in the following topic categories:

Folic Acid
Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Methotrexate
Rheumatic Diseases
TNFR-Fc fusion protein

Additional relevant MeSH terms:

Antimetabolites
Anti-Inflammatory Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Abortifacient Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics

Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Immune System Diseases
Gastrointestinal Agents
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009