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
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 April 16, 2014