A Multicenter Study to Compare the Efficacy and Safety of the Combination of Etanercept and Methotrexate in Treatment of Rheumatoid Arthritis

NCT00783536 | Withdrawn Phase 4

• 1 other identifier: 0881A1-102380
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a randomized, open label, active-comparator, parallel design, outpatient, multicenter study being conducted in Mexico. Subjects with early active Rheumatoid Arthritis (RA) who have not received treatment with a Disease-modifying antirheumatic drug (DMARD) in the previous 6 months will be eligible for the study. Study subjects will be randomized into one of two treatments groups and receive either etanercept + methotrexate or standard non-biologic DMARD therapy.

Conditions

Rheumatoid Arthritis

Keywords

An randomized, open label, multicenter study to compare the ef

Outcome Measures

Primary Outcomes (1)

• Low disease activity

  6 months

Secondary Outcomes (1)

• Effect of the combination therapy on physical function

  6 months

Study Arms (2)

1

EXPERIMENTAL

* Clinical and demographic information * Clinical and Laboratory information

Drug: Etanercept + Methotrexate

2

ACTIVE COMPARATOR

* Clinical and demographic information * Clinical and Laboratory information

Drug: DMARDS

Interventions

Etanercept + Methotrexate DRUG

1

DMARDS DRUG

2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subject age 18 years or older
• Diagnosis of RA
• Disease duration of ≥ 6 months and ≤ 2 years
• Active disease at the time of randomization
• Negative serum pregnancy test at screening if female of childbearing potential.
• Women of childbearing potential participating in the study must use a medically acceptable form of contraception.
• Sexually active male must agree to use a medically accepted form of contraception during the study. If partner is using and acceptable form of contraception, this criteria is not applicable.
• Subject is capable of understanding and signing an informed consent form
• Subject is able and willing to self-inject study drug or have a designee who can do so
• Subject is able and willing to take oral medication 11. Subject is able to store injectable test article at 2° C to 8° C 12. Demonstrates a negative tuberculosis screening test determined by chest
• Exculsion Criteria:
• Subject has received any previous treatment with ETN or other tumor necrosis factor (TNF) antagonist
• Subject has received any of the following DMARDs: methotrexate, leflunomide, hydroxychloroquine, chloroquine, cyclosporine, sulphasalazine, azathioprine, D-penicillamine, cyclophosphamide within the 6 months of screening visit by the rheumatologist
• Subject has received any investigational drug within 3 months of screening visit by the rheumatologist
• Subject has received any biologic agent in the past

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept; Methotrexate; Antirheumatic Agents

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; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: October 31, 2008
• Study Start: November 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: May 9, 2022

Record last verified: 2009-06