Study Comparing Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis in the Asia Pacific Region

NCT00422227 | Completed Phase 4 Results

• 1 other identifier: 0881A1-408
• Study Type: interventional
• Target: 300
• Locations: 8 countries
• Sites: 27

Brief Summary

The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks

  ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening. The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks.

  16 weeks

Secondary Outcomes (9)

• Percentage of Participants Achieving ACR 20, 50, and 70 Responses

  Week 16

• Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)

  Week 16

• Percent Change From Baseline in DAS28 at Week 16

  Week 16

• Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response

  Week 16

• Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2

  Week 16

Study Arms (2)

1

ACTIVE COMPARATOR

Etanercept + Methotrexate

Drug: Etanercept , Methotrexate

2

ACTIVE COMPARATOR

DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide

Drug: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide

Interventions

Etanercept , Methotrexate DRUG

* Etanercept: 25 mg twice weekly over 16 weeks, SC * Methotrexate: \> 7.5 mg/week and no more than 25 mg/week, PO

1

Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide DRUG

* Methotrexate: at least 7.5 mg/wk and not more than 25 mg/wk.;PO * Sulfasalazine: Start treatment w/500 mg daily for 1 wk, thereafter increase dose by 1 tab each wk to a max of 3 g/day;PO * Hydroxychloroquine:400 mg daily in divided dose, may be reduced to 200 mg. Max: 6.5 mg/kg/day * Leflunomide: Initially, loading dose 100 mg daily for 3 days. Maintenance: 20 mg daily

2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of RA
• Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
• Active RA at time of screening and baseline

You may not qualify if:

• Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
• Concurrent treatment with a DMARD, other than MTX, at screening
• Receipt of any DMARD, other than MTX, within 3 months before screening

Sponsors & Collaborators

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

Study Sites (27)

Unknown Facility

Hong Kong, Hong Kong

Location

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Bangalore, 560017, India

Location

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Bangalore, 560034, India

Location

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Hyderabaad, 500082, India

Location

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New Delhi, 110029, India

Location

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Ipoh, Perak, 30450, Malaysia

Location

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Kuala Lumpur, 68100, Malaysia

Location

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Pulau Pinang, 10450, Malaysia

Location

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Putrajaya, 62250, Malaysia

Location

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Seremban, 70300, Malaysia

Location

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Cebu, 6000, Philippines

Location

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Makati City, 1200, Philippines

Location

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Manila, 1000, Philippines

Location

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Manila, 1004, Philippines

Location

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Manila, 1500, Philippines

Location

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Quezon City, 1102, Philippines

Location

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Singapore, 308433, Singapore

Location

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Incheon, Korea, 400-711, South Korea

Location

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Seoul, Korea, 110-744, South Korea

Location

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Seoul, Korea, 120-752, South Korea

Location

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Seoul, Korea, 133-792, South Korea

Location

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Seoul, Korea, 137-701, South Korea

Location

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Seoul, Korea, 138-736, South Korea

Location

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Kaohsiung City, 807, Taiwan

Location

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Taipei, 100, Taiwan

Location

Unknown Facility

Taipei, 112, Taiwan

Location

Unknown Facility

Bangkok, 10400, Thailand

Location

Related Publications (2)

• Fleischmann R, Koenig AS, Szumski A, Nab HW, Marshall L, Bananis E. Short-term efficacy of etanercept plus methotrexate vs combinations of disease-modifying anti-rheumatic drugs with methotrexate in established rheumatoid arthritis. Rheumatology (Oxford). 2014 Nov;53(11):1984-93. doi: 10.1093/rheumatology/keu235. Epub 2014 Jun 6.

  PMID: 24907147 DERIVED

• Bae SC, Gun SC, Mok CC, Khandker R, Nab HW, Koenig AS, Vlahos B, Pedersen R, Singh A. Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis. BMC Musculoskelet Disord. 2013 Jan 8;14:13. doi: 10.1186/1471-2474-14-13.

  PMID: 23294908 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Methotrexate; Sulfasalazine

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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

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

• Trial Manager

  For Hong Kong: medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

• Trial Manager

  For Taiwan: medinfo@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 11, 2007
• First Posted: January 15, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: August 30, 2010
• Results First Posted: August 30, 2010

Record last verified: 2010-07

Locations

IN (4); TH (1); PH (6); KR (6); SG (1); HK (1); MY (5); TW (3)