A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00484237
First received: June 7, 2007
Last updated: December 3, 2007
Last verified: December 2007
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Japan
Goshogawara, Aomori, Japan, 037-0053
Choseigun, Chiba, Japan, 299-4301
Yotsukaido, Chiba, Japan, 284-0003
Fukushima City, Fukushima, Japan, 960-8251
Higashihiroshima, Hiroshima, Japan, 790-0002
Katoh, Hyogo, Japan, 673-1462
Sagamihara, Kanagawa, Japan, 228-8522
Sendai-City, Miyagi, Japan, 982-0032
Sasebo, Nagasaki, Japan, 857-1195
Fukuoka, Japan, 810-0001
Kumamoto, Japan, 862-0976
Nagano, Japan, 380-0928
Oita, Japan, 870-0823
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

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

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
TNFR-Fc fusion protein
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 20, 2014