Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

NCT01578850 | Completed Phase 4 Results

• 2 other identifiers: B18013152011-005448-87
• Study Type: interventional
• Target: 491
• Locations: 19 countries
• Sites: 62

Brief Summary

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; etanercept; methotrexate; DMARDs

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.

  Proportion of participants who remained in LDA DAS28-ESR \<3.2 at Week 52 is presented below.

  Baseline and Week 52

Secondary Outcomes (28)

• Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)

  Baseline and Week 52

• Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1

  Baseline, Weeks 4, 8, 16 and 24

• Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2

  Baseline, Weeks 24, 28, 36, 44 and 52

• Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1

  Baseline, Weeks 4, 8, 16 and 24

• Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2

  Baseline, Weeks 24, 28, 36, 44 and 52

Study Arms (2)

Group A

EXPERIMENTAL

Drug: Etanercept

Group B

PLACEBO COMPARATOR

Drug: placebo

Interventions

Etanercept DRUG

etanercept 50mg once weekly + methotrexate with or without other DMARDs

Group A

placebo DRUG

etanercept placebo once weekly + methotrexate with or without other DMARDs

Group B

Eligibility Criteria

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

You may qualify if:

• Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
• Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

You may not qualify if:

• Subjects who used any of the following systemic treatments during the washout periods given below:
• Oral corticosteroid dose of prednisone \>7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
• Treatment with more than 1 NSAID within 14 days at baseline.
• Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
• Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.
• Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
• Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
• Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (62)

Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia

Salvador, Estado de Bahia, 40050-410, Brazil

Location

CIP (Centro Internacional de Pesquisa)

Goiânia, Goiás, 74110-120, Brazil

Location

CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos LTDA

São Paulo, São Paulo, 04209-003, Brazil

Location

Research Center

Juiz de Fora, Brazil

Location

Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

Location

Chinese Academy of Medical Sciences - Peking Union Medical C

Beijing, 100050, China

Location

Shanghai Changning District Guanghua Hospital of Traditional Chinese and Western Medicine

Shanghai, 200052, China

Location

Shanghai Changhai Hospital[Rheumatology &Immunology]

Shanghai, 200433, China

Location

Hospital Pablo Tobon Uribe (HPTU)

Santa Fe de Antioquia, Antioquia, Colombia

Location

Centro Integral de reumatolo[Gerencia / Representante Legal]

Barranquilla, Atlántico, 99999, Colombia

Location

Fundacion Instituto de Reumatologia Fernando Chalem

Bogota DC, Cundinamarca, Colombia

Location

Revmatologicka poradna III. Interni nefrologicka, revmatologicka a endokrinologicka klinika

Olomouc, Czech Republic, 775 20, Czechia

Location

Revmatologicky ustav

Prague, Czech Republic, 12850, Czechia

Location

Revmatologicka ambulance

Prague, Czech Republic, 150 06, Czechia

Location

PV-Medical s.r.o.

Zlín, Czech Republic, 760 01, Czechia

Location

New University Hospital, Alexandria Clinical Research Center

Alexandria, Alexandria Governorate, 21131, Egypt

Location

Al Azhar University Hospital [Rheumatology]

Cairo, Cairo Governorate, 12111, Egypt

Location

Ain Shams University/Al Demerdash Hospital/Diabetology Unit

Cairo, Egypt

Location

Budai Irgalmasrendi Korhaz

Budapest, 1023, Hungary

Location

Magyar Honvédség Egészségügyi Központ

Budapest, 1062, Hungary

Location

Pharmaceutical Research Center- PRC. Jordan University of Science and Technology

Irbid, 22110, Jordan

Location

American University of Beirut Medical Center

Beirut, Lebanon, 1107-2020, Lebanon

Location

Hopsital Putrajaya [Medicine]

Putrajaya, Putrajaya, 62250, Malaysia

Location

Queen Elizabeth Hospital

Kota Kinabalu, Sabah, 88586, Malaysia

Location

University Malaysia Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Centro de Investigación y Atención Integral de Durango, SC

Durango, Durango / Mexico, 34080, Mexico

Location

Centro de Alta Especialidad en Reumatología e Investigación

San Luis de Potosi, San Luis Potosí / Mexico, 78213, Mexico

Location

Centro Medico Las Americas

Mérida, Yucatán, Mexico

Location

Hospital Central

San Luis Potosí City, 78290, Mexico

Location

De La Salle University Health Sciences Campus- Clinical Epidemiology Unit

Dasmariñas, Cavite, 4114, Philippines

Location

St. Luke's Mecical Center

Quezon, Manila, 1102, Philippines

Location

Angeles University Foundation Medical Center

Angeles City, Pampanga, Philippines

Location

Chong Hua Hospital, Medical Arts Center

Cebu City, 6000, Philippines

Location

UP-Philippine General Hospital, Medical Research Laboratory, Medicine Department,

Manila, 1000, Philippines

Location

Hamad Medical Corporation

Doha, Qatar, 3050, Qatar

Location

Spitalul Clinic Judetean de Urgenta Brasov

Brasov, Brașov County, 500365, Romania

Location

Spitalul Clinic de Recuperare

Iași, Iaşi, 700656, Romania

Location

Spitalul Judetean

Baia Mare, Maramure, 4800, Romania

Location

Spitalul Clinic Judetean de Urgenta Targu Mures

Tg Mures, 540136, Romania

Location

LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7(Legal address)

Kazan', 420097, Russia

Location

LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7 (Actual address)

Kazan', 420137, Russia

Location

Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky

Krasnoyarsk, 660014, Russia

Location

Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky,

Krasnoyarsk, 660022, Russia

Location

FSBSI "Scientific Research Institute of Rheumatology n. a. V.A. Nasonova"

Moscow, 115522, Russia

Location

LLC Institute of Medical Trials (Actual address)

Saint Petersburg, 196084, Russia

Location

Universitas Hospital [Cardiololgy]

Bloemfontein, Free State, 9301, South Africa

Location

Vincent Pallotti Hospital

Cape Town, 7405, South Africa

Location

Winelands Medical Research Centre

Stellenbosch, 7600, South Africa

Location

Cathay General Hospital

Dawan, Taoyuan, 330, Taiwan

Location

Buddhist Tzu Chi General Hospital - Dalin Branch

Chiayi City, 62247, Taiwan

Location

China Medical University Hospital, Division of Rheumatology, Allergy and Immunology

Taichung, 404, Taiwan

Location

Taipei Medical University Hospital

Taipei, 11042, Taiwan

Location

Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,

Amphoe Mueang, Chiang Mai, 50200, Thailand

Location

Siriraj Hospital [Rheumatology]

Bangkok, 10700, Thailand

Location

Khon Kaen University (KKU) - Faculty of Medicine

Khon Kaen, 40002, Thailand

Location

Songklanagarind Hospital

Songkhla, 90110, Thailand

Location

Republican Clinical Hospital, Department of Internal Medicine #2 of Crimean State Medical University

Simferopol, Autonomous Republic of Crimea, 95017, Ukraine

Location

Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"

Kyiv, 04107, Ukraine

Location

Odessa Regional Clinical Hospital, Outpatient Department

Odesa, 65025, Ukraine

Location

Municipal Institution of Ternopil Regional Council Ternopil University Hospital

Ternopil, 46000, Ukraine

Location

Vinnitsa Regional Clinical Hospital n.a. Pirogov, Department of Faculty Therapy of Vinnitsa NMU

Vinnitsa, 21018, Ukraine

Location

Al Baraha Hospital

Dubai, United Arab Emirates

Location

Related Publications (3)

• 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

• Zerbini CAF, Abud-Mendoza C, Mendez-Patarroyo P, De Angelo Andrade M, Pedersen R, Vlahos B, Borlenghi CE. Maintenance of low disease activity and remission with etanercept-disease-modifying antirheumatic drug (DMARD) combination therapy compared with treatment with DMARDs alone in Latin American patients with active rheumatoid arthritis: Subset analysis of a randomized trial. Medicine (Baltimore). 2018 Sep;97(36):e11989. doi: 10.1097/MD.0000000000011989.

  PMID: 30200078 DERIVED

• Pavelka K, Akkoc N, Al-Maini M, Zerbini CAF, Karateev DE, Nasonov EL, Rahman MU, Pedersen R, Dinh A, Shen Q, Vasilescu R, Kotak S, Mahgoub E, Vlahos B. Maintenance of remission with combination etanercept-DMARD therapy versus DMARDs alone in active rheumatoid arthritis: results of an international treat-to-target study conducted in regions with limited biologic access. Rheumatol Int. 2017 Sep;37(9):1469-1479. doi: 10.1007/s00296-017-3749-7. Epub 2017 Jun 9.

  PMID: 28597306 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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2012
• First Posted: April 17, 2012
• Study Start: July 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: July 6, 2016
• Results First Posted: July 6, 2016

Record last verified: 2016-05

Locations

BR (4); TH (4); MY (3); PH (5); JO (1); QA (1); TW (4); ME (4); UA (5); RU (6); CZ (4); HU (2); RO (4); EG (3); CO (3); ZA (3); LE (1); AE (1); CN (4)