A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis - Full Text View

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00484237

Purpose

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: etanercept	Phase III

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Etanercept

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis

Further study details as provided by Wyeth:

Primary Outcome Measures:

The primary comparison of the study will be the change of DAS28-4ESR scores from baseline (week 0) between the 10 mg BIW group (at week 12) and the 25 mg QW group (at week 12).

Secondary Outcome Measures:

ACR 20, 50, and 70; Number of swollen joints (68 joints); Number of painful joints on pressure or motion (71 joints); Physician global assessment; Patient global assessment; Duration of morning stiffness.

Estimated Enrollment:	80
Study Start Date:	April 2007
Study Completion Date:	December 2007

Detailed Description:

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Eligibility

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

Criteria

Inclusion Criteria:

Presence of >6 swollen joints and >6 tender joints
Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit

Exclusion Criteria:

Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
Received investigational drugs within 6 months of the baseline visit
Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00484237

Locations

Japan

Fukuoka, Japan, 810-0001

Kumamoto, Japan, 862-0976

Nagano, Japan, 380-0928

Oita, Japan, 870-0823
Japan, Aomori

Goshogawara, Aomori, Japan, 037-0053
Japan, Chiba

Yotsukaido, Chiba, Japan, 284-0003

Choseigun, Chiba, Japan, 299-4301
Japan, Fukushima

Fukushima City, Fukushima, Japan, 960-8251
Japan, Hiroshima

Higashihiroshima, Hiroshima, Japan, 790-0002
Japan, Hyogo

Katoh, Hyogo, Japan, 673-1462
Japan, Kanagawa

Sagamihara, Kanagawa, Japan, 228-8522
Japan, Miyagi

Sendai-City, Miyagi, Japan, 982-0032
Japan, Nagasaki

Sasebo, Nagasaki, Japan, 857-1195

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

Study ID Numbers:	0881A1-3324
Study First Received:	June 7, 2007
Last Updated:	December 3, 2007
ClinicalTrials.gov Identifier:	NCT00484237
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Wyeth:

Rheumatoid Arthritis

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009