Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

NCT00565409 | Completed Phase 4 Results

• 2 other identifiers: 0881A1-4423B1801003
• Study Type: interventional
• Target: 834
• Locations: 18 countries
• Sites: 78

Brief Summary

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

Conditions

Arthritis, Rheumatoid

Keywords

Active Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88

  DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than \[\<\]20 percent \[%\] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity.

  Week 88

Secondary Outcomes (41)

• Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36

  Baseline, Weeks 4, 8, 12, 20, 28, 36

• Percentage of Participants Achieving DAS28 Low Disease Activity or Remission

  Weeks 36, 40, 48, 56, 64, 72, 80 and 88

• Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36

  Baseline, Weeks 4, 8, 12, 20, 28 and 36

• Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88

  Weeks 36, 40, 48, 56, 64, 72, 80 and 88

• Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28

  Week 36 up to Week 88

Study Arms (3)

1

ACTIVE COMPARATOR

Drug: Etanercept; Drug: Methotrexate

2

ACTIVE COMPARATOR

Drug: Etanercept; Drug: Methotrexate

3

PLACEBO COMPARATOR

Drug: Placebo; Drug: Methotrexate

Interventions

Etanercept DRUG

Subcutaneous (SC), 50 mg, once weekly for 88 weeks

Also known as: Enbrel

1

Methotrexate DRUG

Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks. If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

1

Placebo DRUG

Subcutaneous (SC), once weekly from week 36 to week 88.

3

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 rheumatoid arthritis.
• Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
• Active rheumatoid arthritis at the time of screening.

You may not qualify if:

• Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
• Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
• Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (81)

Pfizer Investigational Site

Campsie, New South Wales, 2194, Australia

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Kogarah, New South Wales, 2217, Australia

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Maroochydore, Queensland, 4558, Australia

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Daw Park, South Australia, 5041, Australia

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Heidelberg West, Victoria, 3081, Australia

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Malvern, Victoria, 3145, Australia

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Victoria Park, 6100, Australia

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Vienna, 1130, Austria

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Brussels, 1200, Belgium

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Liège, 4000, Belgium

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Yvoir, 5530, Belgium

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Santiago, Santiago Metropolitan, Chile

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Barranquilla, Atlántico, Colombia

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Bogota, Cundinamarca, Colombia

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Bruntál, Czech Republic, 79201, Czechia

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Zlín, Czech Republic, 760 01, Czechia

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Brno, 656 91, Czechia

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Bruntál, 792 01, Czechia

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Bruntál, 79201, Czechia

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Prague, 128 50, Czechia

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Prague, 150 06, Czechia

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Montpellier, France, 34059, France

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Corbeil-Essonnes, 91100, France

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Le Kremlin-Bicêtre, 94270, France

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Le Mans, 72037, France

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Nice, 06202, France

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Paris, 75018, France

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Strasbourg, 67098, France

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Toulouse, 31059, France

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Berlin, 10117, Germany

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Cologne, 50937, Germany

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Eilbek, 22081, Germany

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Leipzig, 04103, Germany

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Leipzig, 4103, Germany

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Würzburg, 97080, Germany

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Budapest, 1023, Hungary

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Debrecen, 4012, Hungary

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Debrecen, H-4032, Hungary

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Szombathely, 9701, Hungary

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Catania, CT, 95100, Italy

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Orbassano, TO, 10043, Italy

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Roma, 00128, Italy

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Mexico City, Mexico DF, 11500, Mexico

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Guadalajara, Mexico, 44650, Mexico

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Mérida, Yucatán, 97000, Mexico

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Mexico City, 06700, Mexico

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Monterrey, 64020, Mexico

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Querétaro, 76000, Mexico

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Heerlen, 6419 PC, Netherlands

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Bydgoszcz, 85-168, Poland

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Lodz, 93-513, Poland

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Lublin, 20-954, Poland

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Szczecin, 71-252, Poland

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Warsaw, Poland

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Moscow, 115522, Russia

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Moscow, 119002, Russia

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Moscow, 129110, Russia

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Moscow, Russia

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Saint Petersburg, 194291, Russia

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Saint Petersburg, 199004, Russia

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Belgrade, 11000, Serbia and Montenegro

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Niska Banja, 18205, Serbia and Montenegro

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Seo-gu, Daejeon, 302-799, South Korea

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Namdong-gu, Incheon, 405-760, South Korea

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Seoul, Korea, 135-720, South Korea

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Seongdong-gu, Seoul, 133-792, South Korea

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Anyang-si Gyeonggi-do, 431-070, South Korea

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Seoul, 134-701, South Korea

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Seoul, 143-729, South Korea

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Santiago de Compostela, A Coruña, 157 06, Spain

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Barcelona, Barcelona, 08036, Spain

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Sabadell, Barcelona, 08208, Spain

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A Coruña, La Coruña, 15006, Spain

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Málaga, Malaga, 29009, Spain

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Seville, Sevilla, 41009, Spain

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Falun, 79182, Sweden

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Oskarström, 31392, Sweden

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Tapei City, ROC, 114, Taiwan

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Kaohsiung City, 807, Taiwan

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Wigan, Lancashire, WN6 9EP, United Kingdom

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Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Related Publications (5)

• Tanaka Y, Smolen JS, Jones H, Szumski A, Marshall L, Emery P. The effect of deep or sustained remission on maintenance of remission after dose reduction or withdrawal of etanercept in patients with rheumatoid arthritis. Arthritis Res Ther. 2019 Jul 5;21(1):164. doi: 10.1186/s13075-019-1937-4.

  PMID: 31277720 DERIVED

• Smolen JS, Pedersen R, Jones H, Mahgoub E, Marshall L. Impact of flare on radiographic progression after etanercept continuation, tapering or withdrawal in patients with rheumatoid arthritis. Rheumatology (Oxford). 2020 Jan 1;59(1):153-164. doi: 10.1093/rheumatology/kez224.

  PMID: 31257453 DERIVED

• Smolen JS, Szumski A, Koenig AS, Jones TV, Marshall L. Predictors of remission with etanercept-methotrexate induction therapy and loss of remission with etanercept maintenance, reduction, or withdrawal in moderately active rheumatoid arthritis: results of the PRESERVE trial. Arthritis Res Ther. 2018 Jan 16;20(1):8. doi: 10.1186/s13075-017-1484-9.

  PMID: 29338762 DERIVED

• Smolen JS, Strand V, Koenig AS, Szumski A, Kotak S, Jones TV. Discordance between patient and physician assessments of global disease activity in rheumatoid arthritis and association with work productivity. Arthritis Res Ther. 2016 May 21;18(1):114. doi: 10.1186/s13075-016-1004-3.

  PMID: 27209012 DERIVED

• Smolen JS, Nash P, Durez P, Hall S, Ilivanova E, Irazoque-Palazuelos F, Miranda P, Park MC, Pavelka K, Pedersen R, Szumski A, Hammond C, Koenig AS, Vlahos B. Maintenance, reduction, or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet. 2013 Mar 16;381(9870):918-29. doi: 10.1016/S0140-6736(12)61811-X. Epub 2013 Jan 17.

  PMID: 23332236 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Methotrexate

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

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 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 30, 2007
• Study Start: March 1, 2008
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 10, 2015
• Results First Posted: August 10, 2015

Record last verified: 2015-08

Locations

KR (7); AU (7); ME (6); TW (2); NL (1); GB (2); CL (1); PL (5); RU (6); SE (2); CZ (7); CO (2); IT (3); DE (6); HU (4); FR (8); ES (6); BE (3)