Open-Label Study Comparing Etanercept to Conventional Disease Modifying Antirheumatic Drug (DMARD) Therapy

NCT00848354 | Completed Phase 4 Results

• 2 other identifiers: 0881A1-4532B1801004
• Study Type: interventional
• Target: 429
• Locations: 5 countries
• Sites: 33

Brief Summary

The purpose of this 2 phased, open-label study is to compare the safety and efficacy of etanercept with conventional Disease Modifying Antirheumatic Drug (DMARD) therapy in Latin American subjects with moderate to severe rheumatoid arthritis over 128 weeks. Phase 1 is a randomized 24 week treatment period; Phase 2 is an optional open-label 104 week period that allows the investigator to choose continuation with the phase I treatment or the addition, discontinuation or titration of other DMARD therapy already being utilized for the study.

Conditions

Rheumatoid Arthritis

Keywords

enbrel; moderate arthritis; severe arthritis; rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Achieving American College of Rheumatology 50 (ACR50) Response at Week 24

  ACR50 response: greater than or equal to 50 percent improvement from Baseline in tender joint count and swollen joint count; and greater than or equal to 50 percent improvement from Baseline in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; participant's self-assessed disability (disability index of the Health Assessment Questionnaire; HAQ); and C-Reactive Protein (CRP).

  Week 24

Secondary Outcomes (70)

• Change From Baseline in HAQ Score at Week 24

  Baseline and Week 24

• Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Score at Week 24

  Baseline and Week 24

• Change From Baseline in Van Der Heijde Modified Total Sharp Score (vdH mTSS), Annualized, at Week 24

  Baseline and Week 24

• Change From Baseline in Disease Activity Score Based on a 28-joint Count (DAS28) at Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

  Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

• Change From Baseline in DAS28 at Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

  Week 37, Week 50, Week 63, Week 76, Week 89, Week 102, Week 115, and Week 128

Study Arms (2)

Phase 1 Etanercept + methotrexate

EXPERIMENTAL

Phase 1: Etanercept + methotrexate

Biological: Phase 1: Etanercept; Drug: Phase 1: Methotrexate; Drug: Phase 2: Optional ETN, SSZ, HCQ, MTX

Phase 1 Conventional DMARD (SSZ or HCQ) + MTX

ACTIVE COMPARATOR

Phase 1: Sulfasalazine (SSZ) + methotrexate (MTX) OR Phase 1: Hydrocholoquine (HCQ) + methotrexate

Drug: Phase 1: Methotrexate; Drug: Phase 1: Conventiaonal DMARD

Interventions

Phase 1: Etanercept BIOLOGICAL

Phase 1: prefilled syringe 50mg/ml, administered once weekly for study weeks 0 - 24

Also known as: Enbrel

Phase 1 Etanercept + methotrexate

Phase 1: Methotrexate DRUG

Phase 1: oral tablet, 2.5mg, dose variable from 7.5mg to 25mg, once weekly for study weeks 0 - 24.

Phase 1 Etanercept + methotrexate

Phase 2: Optional ETN, SSZ, HCQ, MTX DRUG

Phase 2: All therapies are optional and may include any combination of the following: ETN, SSZ, HCQ, MTX Phase 2: Optional ETN: prefilled syringe 50mg/ml, dose variable after study week 24 to week 128. Phase 2: Optional SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations after study week 24 to week 128. Phase 2: MTX: oral tablet, 2.5mg dose variable after week 24 to week 128.

Phase 1 Etanercept + methotrexate

Phase 1: Conventiaonal DMARD DRUG

Phase 1: SSZ: oral tablet, 0.5gm, dose variable per approved local label recommendations. OR Phase 1: HCQ: oral tablet, 200mg, dose variable per approved local label recommendations.

Phase 1 Conventional DMARD (SSZ or HCQ) + MTX

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Rheumatoid Arthritis (RA)
• Currently receiving a suboptimal response to a stable dose of methotrexate for treatment of Rheumatoid Arthritis (RA)
• Active Rheumatoid Arthritis (RA) at time of screening and baseline

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead
• Amgen: collaborator

Study Sites (33)

Investigaciones Reumatológicas y Osteológicas

Buenos Aires, Argentina, C1114AAH, Argentina

Location

OMI

Buenos Aires, Buenos Aires, 1015, Argentina

Location

Centro de Investigaciones en Enfermedades Reumaticas

Buenos Aires, Buenos Aires, 1055, Argentina

Location

Hospital Britanico

Buenos Aires, Buenos Aires, 1280, Argentina

Location

Atencion Integral en Reumatologia

Buenos Aires, Buenos Aires, 1426, Argentina

Location

Consultorios Especializados en Investigaciones Medicas

Capital Federal, Buenos Aires, C1425EKF, Argentina

Location

Hospital Escuela Gral. San Martin

Corrientes, Corrientes Province, 3400, Argentina

Location

CER San Juan

San Juan, Provinica de San Juan, 5400, Argentina

Location

Instituto CAICI

Rosario, Santa Fe Province, S2000PBJ, Argentina

Location

Centro de Investigaciones Reumatologicas

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro de Osteopatías Médicas

Buenos Aires, C1128AAF, Argentina

Location

Sanatorio Mayo

Córdoba, 5000, Argentina

Location

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, 4000, Argentina

Location

Dr Miranda Private Practice

Santiago, Santiago Metropolitan, Chile

Location

Hospital del Salvador

Santiago, Santiago Metropolitan, Chile

Location

Reumalab

Medellín, Antioquia, Colombia

Location

Centro de Reumatologia y Ortopedia

Barranquilla, Atlántico, Colombia

Location

IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 1

Barranquilla, Atlántico, Colombia

Location

IPS Centro Integral de Rematología del Caribe S.A.S CIRCARIBE S.A.S Sede 2

Barranquilla, Atlántico, Colombia

Location

Centro Integral de Reumatologia e Inmunologia LTDA

Bogota, Cundinamarca, 0000, Colombia

Location

Foqus Ips Ltda

Bogota, Cundinamarca, Colombia

Location

Fundacion Instituto de Reumatologia Fernando Chalem

Bogota, Cundinamarca, Colombia

Location

Riesgo de fractura S.A. Clinica de Artritis y Rehabilitacion

Bogota, Cundinamarca, Colombia

Location

Preventive Care Ltda

Chía, Cundinamarca, Colombia

Location

Centro Medico Carlos Ardila Lulle

Bucaramanga, Santander Department, Colombia

Location

Servimed EU

Bucaramanga, Santander Department, Colombia

Location

Centro de Investigación y Biomedicina de Chihuahua

Chihuahua City, Chihuahua, 31000, Mexico

Location

Hospital Christus Mugerza

Chihuahua City, Chihuahua, 31000, Mexico

Location

Hospital Christus Muguerza del Parque

Chihuahua City, Chihuahua, 31000, Mexico

Location

Hospital Angeles Chapalita

Guadajara, Jalisco, 45040, Mexico

Location

Centro de Especialidades Medicas del Sureste SA de CV

Mérida, Yucatán, Mexico

Location

Centro de Infusion Marbella

Panama City, Panama

Location

Centro de Investigacion Marbella

Panama City, Panama

Location

Related Publications (5)

• de la Vega M, Guerra Bautista G, Xavier RM, Pacheco-Tena C, Solano G, Pedersen RD, Szumski AE, Borlenghi C, Santana K, Vlahos B. Predictors of response to etanercept-methotrexate treatment: a post hoc logistic regression analysis of a randomized, open-label study in Latin American patients with rheumatoid arthritis. Adv Rheumatol. 2021 Sep 8;61(1):56. doi: 10.1186/s42358-021-00213-4.

  PMID: 34496979 DERIVED

• Guerra Bautista G, Xavier RM, de la Vega M, Simon-Campos JA, Solano G, Pedersen RD, Vlahos B, Borlenghi C. Clinical Improvements as Predictors of Improvements in Patient-Reported Outcomes: Post Hoc Analysis of a Randomized, Open-Label Study of Etanercept in Latin American Patients with Rheumatoid Arthritis. Open Access Rheumatol. 2019 Dec 12;11:275-281. doi: 10.2147/OARRR.S228866. eCollection 2019.

  PMID: 31849542 DERIVED

• Machado DA, Guzman R, Xavier RM, Simon JA, Mele L, Shen Q, Pedersen R, Kotak S, Vlahos B. Two-Year Safety and Efficacy Experience in Patients with Methotrexate-Resistant Active Rheumatoid Arthritis Treated with Etanercept and Conventional Disease-Modifying Anti-rheumatic Drugs in the Latin American Region. Open Rheumatol J. 2016 Feb 29;10:13-25. doi: 10.2174/1874312901610010013. eCollection 2016.

  PMID: 27006728 DERIVED

• 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

• Machado DA, Guzman RM, Xavier RM, Simon JA, Mele L, Pedersen R, Ferdousi T, Koenig AS, Kotak S, Vlahos B. Open-label observation of addition of etanercept versus a conventional disease-modifying antirheumatic drug in subjects with active rheumatoid arthritis despite methotrexate therapy in the Latin American region. J Clin Rheumatol. 2014 Jan;20(1):25-33. doi: 10.1097/RHU.0000000000000055.

  PMID: 24356474 DERIVED

Related Links

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

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis

Interventions

Etanercept; Hydroxychloroquine

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; Chloroquine; Aminoquinolines; Quinolines; 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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 20, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 18, 2016
• Results First Posted: April 19, 2012

Record last verified: 2015-12

Locations

PA (2); CL (2); ME (5); CO (11); AR (13)