Open Label, Dose-Regimen Study Evaluating Etanercept 50 mg Once-Weekly In Japanese Subjects With RA

NCT00418717 | Completed Phase 3 Results

• 1 other identifier: 0881A1-321
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 12

Brief Summary

The primary purpose of this study is to evaluate the safety and efficacy of a once-weekly dose of etanercept for rheumatoid arthritis. Currently, patients in Japan can only use 25 mg etanercept two times a week. If a once-a-week regimen of 50 mg is approved, this would be more convenient for most patients. This once-weekly regimen is used in countries outside of Japan.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (1)

• Disease Activity Score Using 28-joint Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4ESR) by Treatment Period.

  DAS28-4ESR is a clinical index of rheumatoid arthritis disease activity based on information from swollen joints, tender joints, acute phase response (Erythrocyte Sedimentation Rate) and general health. DAS28-4ESR scores range from 0 - 10, where a score of less than or equal to 3.2 implies well controlled disease and greater than or equal to 5.1 implies active disease. In this analysis, the DAS28-4ESR is compared for 2 different treatment regimens (used sequentially by the same patient population): Treatment Period A: ETN 25 mg BW (at week 4) vs Treatment Period B: ETN 50 mg QW (at week 12).

  weeks 4 and 12

Secondary Outcomes (1)

• Area Under the Concentration-Time Curve (AUC)

  7 days after week 4 and 7 days after week 12

Study Arms (1)

1

EXPERIMENTAL

Arm 1: Period A-25mg BW; Arm 1: Period B-50mg QW

Drug: etanercept

Interventions

etanercept DRUG

Period A: Weeks 1-4: Etanercept 25mg (25mg vial)bi-weekly (BW); Period B: Weeks 5-12: Etanercept 50mg (50mg vial) weekly (QW)

1

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of Japanese ancestry and living in Japan.
• Subjects who are receiving the approved dose of 25 mg etanercept BIW for at least 6 months and have stable disease activity, as determined by investigator's judgment for 3 months before test articles administration.
• Subjects who have mildly active rheumatoid arthritis as demonstrated by 5 swollen joints and 5 tender/painful joints.

You may not qualify if:

• Prior treatment with Disease Modifying Anti-Rheumatic Drugs (DMARDs) and/or methotrexate (MTX) within 6 months of the baseline visit.
• Subjects considered being in disease remission, per investigator's judgment.
• Received other biological drugs, rituximab, anti-CD-4 agents, or diphtheria interleukin-2 fusion protein (DAB-IL-2) within 6 months prior to baseline.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (12)

Unknown Facility

Nunoya-cho Goshogawara, Aomori, 037-0053, Japan

Location

Unknown Facility

Kokubu, Kurume, Fukuoka, 839-0863, Japan

Location

Unknown Facility

Inomachi Takasaki, Gunma, 370-0004, Japan

Location

Unknown Facility

Higashiuneno Kawanishi, Hyōgo, 666-0195, Japan

Location

Unknown Facility

Mukogawa-cho, Nishinomiya, Hyōgo, 663-8501, Japan

Location

Unknown Facility

Kamiyokoba, Tsukuba, Ibaraki, 305-0854, Japan

Location

Unknown Facility

Douhaku, Suzuka, Mie-ken, 513-0824, Japan

Location

Unknown Facility

Hazama, Isobe-cho, Shima, Mie-ken, 517-0214, Japan

Location

Unknown Facility

Hisai Myojin-cho, Tsu, Mie-ken, 514-1101, Japan

Location

Unknown Facility

Yamato, Sasebo, Nagasaki, 857-1195, Japan

Location

Unknown Facility

Higashizuka, Kurashiki, Okayama-ken, 712-8044, Japan

Location

Unknown Facility

Toranomon, Minato-ku, Tokyo, 105-0001, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 2, 2007
• First Posted: January 5, 2007
• Study Start: February 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 2, 2012
• Results First Posted: May 4, 2010

Record last verified: 2012-03

Locations

JP (12)