Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis

NCT00913458 | Completed Phase 4 Results

• 2 other identifiers: 0881X1-4524B1801020
• Study Type: interventional
• Target: 306
• Locations: 13 countries
• Sites: 59

Brief Summary

Study to evaluate whether there is sustained remission and productivity in subjects with early rheumatoid arthritis started on etanercept plus methotrexate treatment.

Conditions

Active Rheumatoid Arthritis; Arthritis, Rheumatoid; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants That Met Sustained Remission at Week 76 and Week 91 Based on DAS28 Score

  Sustained remission was defined as a DAS28 \<2.6 at the Week 76 and Week 91 visits without requiring a corticosteroid boost between the Week 52 and Week 64 visits, where the requirement for a corticosteroid boost was defined as a value of DAS28 \>3.2 at either the Week 56 or Week 64 visit. DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity. The participants who met sustained remission in both Week 76 and 91 are presented here.

  76 and 91 weeks

Secondary Outcomes (37)

• Number of Participants Achieving Complete Response (Using Disease Activity Score Based on 28-joint Count, Modified Total Sharp Score, Health Assessment Questionnaire)

  End of Phase 1

• Change From Baseline in Modified Total Sharp Score (mTSS) at Week 52 and Final on Therapy

  52 week and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)

• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Overall Work Impairment Due to Problem

  13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)

• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Impairment While Working Due to Problem

  13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)

• Change From Baseline in Work Productivity and Activity Impairment (WPAI) Questionnaire: Percent Work Time Missed Due to Problem

  13, 26, 39, 52 weeks and Final on Therapy (includes all visits for a participant up to Week 52 or the visit they discontinued at)

Study Arms (1)

1

EXPERIMENTAL

etanercept + methotrexate; etanercept + methotrexate

Drug: etanercept

Interventions

etanercept DRUG

Also known as: Enbrel

1

Eligibility Criteria

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

You may qualify if:

• Diagnosis of early rheumatoid arthritis.
• Methotrexate (MTX) naive.
• Active early rheumatoid arthritis at the time of enrollment.

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), within 4 weeks before baseline.
• Concurrent treatment with more than 1 non-steroidal anti-inflammatory drug (NSAID) at baseline.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (59)

Pfizer Investigational Site

Lyon, 69437, France

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Montpellier, 34293, France

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Paris, 75018, France

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Paris, 75651, France

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Paris, 75679, France

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Strasbourg, 67098, France

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Toulouse, 31059, France

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Vogelsang, Gommern, 39245, Germany

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Altona, 22767, Germany

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Elmshorn, 25335, Germany

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Halle, 06108, Germany

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Halle, 06128, Germany

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Hamburg, 22147, Germany

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Ludwigsfelde, 14974, Germany

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München, 80336, Germany

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Osnabrück, 49074, Germany

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Rostock, 18059, Germany

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Würzburg, 97070, Germany

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Zerbst, 39261, Germany

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Dublin, Ireland, DUBLIN 4, Ireland

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Pavia, 27100, Italy

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Pisa, 56126, Italy

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Monaco, 98000, Monaco

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Amsterdam, North Holland, 1105 AZ, Netherlands

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Haarlem, 2035 RC, Netherlands

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Heerlen, 6419 PC, Netherlands

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Ustroń, Poland, 43-450, Poland

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Warsaw, Poland, 04-141, Poland

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Żyrardów, Poland, 96-300, Poland

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Bydgoszczy, 85-168, Poland

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Poznan, 61-545, Poland

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Torun, 87-100, Poland

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Warsaw, 02-637, Poland

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Wroclaw, 50-556, Poland

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Doha, Qatar, 3050, Qatar

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Bucharest, Romania, 020475, Romania

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Bucharest, Romania, 020983, Romania

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Bucharest, 010584, Romania

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Bucharest, 011172, Romania

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Bucharest, 020125, Romania

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Bucharest, 020983, Romania

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Târgu Mureş, 540136, Romania

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Yaroslavl, 150062, Russia

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Barcelona, Barcelona, 8036, Spain

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A Coruña, La Coruna, 15006, Spain

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Madrid, Madrid, 28046, Spain

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Oviedo, Principality of Asturias, 33006, Spain

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Barcelona, Spain, 8907, Spain

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Valencia, Valencia, 46014, Spain

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Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

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Chur, 7000, Switzerland

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Lausanne, 1011, Switzerland

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Wigan, Lancaster, WN6 9EP, United Kingdom

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Manchester, Manchester, M13 9WL, United Kingdom

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Harrogate, North Yorkshire, HG2 7SX, United Kingdom

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Dudley, West Midlands, DY1 2HQ, United Kingdom

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Leeds, West Yorkshire, LS7 4SA, United Kingdom

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London, E11 1NR, United Kingdom

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Pfizer Investigational Site

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Related Publications (6)

• 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

• Fleischmann RM, van der Heijde D, Gardiner PV, Szumski A, Marshall L, Bananis E. DAS28-CRP and DAS28-ESR cut-offs for high disease activity in rheumatoid arthritis are not interchangeable. RMD Open. 2017 Jan 30;3(1):e000382. doi: 10.1136/rmdopen-2016-000382. eCollection 2017.

  PMID: 28255449 DERIVED

• Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Impact of etanercept tapering on work productivity in patients with early rheumatoid arthritis: results from the PRIZE study. RMD Open. 2016 Jul 7;2(2):e000222. doi: 10.1136/rmdopen-2015-000222. eCollection 2016.

  PMID: 27486524 DERIVED

• Wiland P, Dudler J, Veale D, Tahir H, Pedersen R, Bukowski J, Vlahos B, Williams T, Gaylord S, Kotak S. The Effect of Reduced or Withdrawn Etanercept-methotrexate Therapy on Patient-reported Outcomes in Patients with Early Rheumatoid Arthritis. J Rheumatol. 2016 Jul;43(7):1268-77. doi: 10.3899/jrheum.151179. Epub 2016 Jun 1.

  PMID: 27252426 DERIVED

• Zhang W, Bansback N, Sun H, Pedersen R, Kotak S, Anis AH. Estimating the monetary value of the annual productivity gained in patients with early rheumatoid arthritis receiving etanercept plus methotrexate: interim results from the PRIZE study. RMD Open. 2015 Apr 8;1(1):e000042. doi: 10.1136/rmdopen-2014-000042. eCollection 2015.

  PMID: 26535135 DERIVED

• Emery P, Hammoudeh M, FitzGerald O, Combe B, Martin-Mola E, Buch MH, Krogulec M, Williams T, Gaylord S, Pedersen R, Bukowski J, Vlahos B. Sustained remission with etanercept tapering in early rheumatoid arthritis. N Engl J Med. 2014 Nov 6;371(19):1781-92. doi: 10.1056/NEJMoa1316133.

  PMID: 25372086 DERIVED

Related Links

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

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: 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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: June 4, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 17, 2014
• Results First Posted: July 17, 2014

Record last verified: 2014-07

Locations

RU (1); CH (3); IE (1); RO (7); PL (8); FR (7); NL (3); QA (1); GB (7); MO (1); IT (2); ES (6); DE (12)