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

Sponsored by:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00848354

Purpose

The purpose of this 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 24 weeks.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Etanercept Drug: Methotrexate Drug: Sulfasalazine Drug: Hydroxychloroquine	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Open-Label Study In the Latin America Region Comparing the Safety And Efficacy Of Etanercept With Conventional DMARD Therapy In Subjects With Rheumatoid Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Hydroxychloroquine Etanercept Sulfasalazine Hydroxychloroquine sulfate

U.S. FDA Resources

Further study details as provided by Wyeth:

Primary Outcome Measures:

American College of Rheumatology (ACR) response [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety will be measured based on the number of Adverse Events and Serious Adverse Events [ Time Frame: 28 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	414
Study Start Date:	May 2009
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Etanercept + methotrexate: Active Comparator Etanercept + methotrexate	Drug: Etanercept Drug: Methotrexate
Conventional DMARD (SSZ) + methotrexate: Active Comparator Sulfasalazine + methotrexate	Drug: Methotrexate Drug: Sulfasalazine
Conventional DMARD (HCQ) + methotrexate: Active Comparator Hydroxychloroquine + methotrexate	Drug: Methotrexate Drug: Hydroxychloroquine

Eligibility

Ages Eligible for Study:	18 Years to 69 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00848354

Contacts

Contact: Trial Manager

clintrialparticipation@wyeth.com

Locations

Colombia
	Recruiting
Bogota Cundinamarca, Colombia, 20A-27
	Recruiting
Barranquilla Atlantico, Colombia, 82-120
	Recruiting
Bogota Cundinamarca, Colombia, 98-38
	Recruiting
Centro Comercial Cabecera Bucaramanga Santander, Colombia, 34-17

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Responsible Party:	Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) )
Study ID Numbers:	0881A1-4532
Study First Received:	February 18, 2009
Last Updated:	August 3, 2009
ClinicalTrials.gov Identifier:	NCT00848354 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Argentina: Human Research Bioethics Committee; Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health; Brazil: National Health Surveillance Agency; Chile: Comisión Nacional de Investigación Científica y Tecnológica; Chile: Instituto de Salud Publica de Chile; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Colombia: Institutional Review Board; Ecuador: Public Health Ministry; Mexico: Federal Commission for Protection Against Health Risks; Mexico: Federal Commission for Sanitary Risks Protection; Mexico: Ministry of Health; Mexico: National Council of Science and Technology; Mexico: National Institute of Public Health, Health Secretariat

Study placed in the following topic categories:

Antimetabolites
Anti-Inflammatory Agents
Anti-Infective Agents
Immunologic Factors
Sulfasalazine
Arthritis, Rheumatoid
Folate
TNFR-Fc fusion protein
Vitamin B9
Antimalarials
Musculoskeletal Diseases
Arthritis
Connective Tissue Diseases
Methotrexate

Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Autoimmune Diseases
Joint Diseases
Rheumatic Diseases
Folic Acid Antagonists
Folinic Acid
Immunosuppressive Agents
Folic Acid
Analgesics, Non-Narcotic
Hydroxychloroquine
Peripheral Nervous System Agents
Antirheumatic Agents

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Antimetabolites
Anti-Infective Agents
Antiprotozoal Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Sulfasalazine
Physiological Effects of Drugs
Arthritis, Rheumatoid
Reproductive Control Agents
TNFR-Fc fusion protein
Antimalarials
Antiparasitic Agents

Musculoskeletal Diseases
Sensory System Agents
Arthritis
Therapeutic Uses
Abortifacient Agents
Connective Tissue Diseases
Methotrexate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Autoimmune Diseases
Immune System Diseases
Joint Diseases
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 30, 2009