Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis - Full Text View

Sponsor:	Pfizer
Information provided by (Responsible Party):	Pfizer
ClinicalTrials.gov Identifier:	NCT00913458

Purpose

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

Condition	Intervention	Phase
Active Rheumatoid Arthritis Arthritis, Rheumatoid Rheumatoid Arthritis	Drug: etanercept	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A 3-Phase Study to Evaluate Sustained Remission and Productivity Outcomes in Subjects With Early Rheumatoid Arthritis Initiated on Treatment With Etanercept Plus Methotrexate

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Methotrexate Methotrexate sodium

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Sustained remission (using Disease Activity Score based on a 28-joint count) [ Time Frame: 91 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Complete response (using Disease Activity Score based on a 28-joint count, modified total Sharp Score, Health Assessment Questionnaire) [ Time Frame: 52 weeks and 91 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2009
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 etanercept + methotrexate; etanercept + methotrexate	Drug: etanercept Other Name: Enbrel

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00913458

Show 59 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT00913458 History of Changes
Other Study ID Numbers:	0881X1-4524, B1801020
Study First Received:	May 26, 2009
Last Updated:	April 19, 2012
Health Authority:	European Union: European Medicines Agency

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
TNFR-Fc fusion protein
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions

Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

ClinicalTrials.gov processed this record on May 24, 2012