Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis

NCT00445770 | Completed Phase 3 Results

• 2 other identifiers: 0881A1-315B1801002
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 41

Brief Summary

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.

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis; Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52

  mTSS = sum of erosion and JSN scores for 44 joints (16 per hand and 6 per foot). mTSS scores ranged from 0 (normal) to 448 (worst possible total score). Change = scores at observation minus score at Baseline. An increase in mTSS from baseline represented disease progression and/or joint worsening, no change represented halting of disease progression, and a decrease represents improvement.

  Week 52

Secondary Outcomes (19)

• Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24

  Week 24

• Change From Baseline in Erosion Score at Weeks 24 and 52

  Baseline, Week 24, and Week 52

• Change From Baseline in Joint Space Narrowing (JSN) Score at Weeks 24 and 52

  Baseline, Week 24, and Week 52

• Percentage of Participants With no Progression of Joint Destruction at Week 52

  Baseline and Week 52

• Change From Baseline in Swollen Joint Count at Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

  Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, 48, and 52

Other Outcomes (1)

• Comparison of Etanercept Serum Concentrations Between the 10 mg and 25 mg Etanercept Doses

  Weeks 12, 24, 52

Study Arms (3)

1

EXPERIMENTAL

Drug: Etanercept

2

EXPERIMENTAL

Drug: Etanercept

3

ACTIVE COMPARATOR

Drug: Methotrexate

Interventions

Etanercept DRUG

10 mg twice weekly, subcutaneous injection for 52 weeks

1

Methotrexate DRUG

up to 8 mg per week, oral dosing for 52 weeks

3

Eligibility Criteria

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

You may qualify if:

• Must be Japanese and live in Japan
• Must be age 20 to 75 years
• Diagnosed less than or equal to 10 years from time of first visit

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (41)

Pfizer Investigational Site

Nagoya, Aichi-ken, 460-0001, Japan

Location

Pfizer Investigational Site

Nagoya, Aichi-ken, 4678602, Japan

Location

Pfizer Investigational Site

Goshogawara, Aomori, 037-0053, Japan

Location

Pfizer Investigational Site

Asahi, Chiba, 289-2511, Japan

Location

Pfizer Investigational Site

Matsuyama, Ehime, 790-8524, Japan

Location

Pfizer Investigational Site

Fukui-shi, Fukui, 9108561, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, 814-0002, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, 815-8588, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, 8150063, Japan

Location

Pfizer Investigational Site

Iizuka, Fukuoka, 820-8505, Japan

Location

Pfizer Investigational Site

Kurume, Fukuoka, 830-8543, Japan

Location

Pfizer Investigational Site

Kurume, Fukuoka, 8390863, Japan

Location

Pfizer Investigational Site

Munakata, Fukuoka, 8113431, Japan

Location

Pfizer Investigational Site

Takasaki, Gunma, 370-0053, Japan

Location

Pfizer Investigational Site

Hiroshima, Hiroshima, 7300031, Japan

Location

Pfizer Investigational Site

Asahikawa, Hokkaido, 078-8243, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, 060-0001, Japan

Location

Pfizer Investigational Site

Kakogawa, Hyōgo, 6750009, Japan

Location

Pfizer Investigational Site

Katoh, Hyōgo, 673-1462, Japan

Location

Pfizer Investigational Site

Yūki, Ibaraki, 307-0001, Japan

Location

Pfizer Investigational Site

Komatsu, Ishikawa-ken, 923-8560, Japan

Location

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, 8900067, Japan

Location

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, 891-0133, Japan

Location

Pfizer Investigational Site

Kawasaki, Kanagawa, 2120014, Japan

Location

Pfizer Investigational Site

Sagamihara, Kanagawa, 228-8522, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, 2310045, Japan

Location

Pfizer Investigational Site

Kumamoto, Kumamoto, 862-0976, Japan

Location

Pfizer Investigational Site

Kumamoto, Kumamoto, 8620965, Japan

Location

Pfizer Investigational Site

Miyagi, Miyagi, 9810112, Japan

Location

Pfizer Investigational Site

Sendai, Miyagi, 9820032, Japan

Location

Pfizer Investigational Site

Hyūga, Miyazaki, 8830043, Japan

Location

Pfizer Investigational Site

Miyazaki, Miyazaki, 8800122, Japan

Location

Pfizer Investigational Site

Sasebo, Nagasaki, 857-1195, Japan

Location

Pfizer Investigational Site

Ikoma, Nara, 630-0293, Japan

Location

Pfizer Investigational Site

Kawagoe, Saitama, 350-8550, Japan

Location

Pfizer Investigational Site

Tokorozawa, Saitama, 359-1111, Japan

Location

Pfizer Investigational Site

Bunkyo-ku, Tokyo, 113-8549, Japan

Location

Pfizer Investigational Site

Ōta-ku, Tokyo, 1438541, Japan

Location

Pfizer Investigational Site

Sumida-ku, Tokyo, 130-0013, Japan

Location

Pfizer Investigational Site

Toyama, Toyama, 9338525, Japan

Location

Pfizer Investigational Site

Kato City Fujita Letter Higashiyama, 944-25, Japan

Location

Related Publications (2)

• Takeuchi T, Miyasaka N, Pedersen RD, Sugiyama N, Hirose T. Radiographic and clinical effects of 10 mg and 25 mg twice-weekly etanercept over 52 weeks in Japanese patients with active rheumatoid arthritis. Mod Rheumatol. 2021 Mar;31(2):319-325. doi: 10.1080/14397595.2020.1805142. Epub 2020 Sep 7.

  PMID: 32735145 DERIVED

• Takeuchi T, Miyasaka N, Pedersen R, Sugiyama N, Hirose T. Radiographic and clinical outcomes following etanercept monotherapy in Japanese methotrexate-naive patients with active rheumatoid arthritis. Mod Rheumatol. 2020 Mar;30(2):259-268. doi: 10.1080/14397595.2019.1589918. Epub 2019 Mar 29.

  PMID: 30836801 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Etanercept; Methotrexate

Condition Hierarchy (Ancestors)

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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Total Sharp Score and modified total Sharp Score were used interchangeably in the protocol and meant the same thing. In the statistical analysis plan and study results, mTSS was used consistently.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  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: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 8, 2007
• First Posted: March 9, 2007
• Study Start: July 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 15, 2011
• Results First Posted: August 5, 2011

Record last verified: 2011-08

Locations

JP (41)