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Study Comparing Etanercept in Combination With Methotrexate in Subjects With Rheumatoid Arthritis

NCT00565409 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 834

Last updated 2015-08-10

Study results available
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Summary

To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Etanercept

Subcutaneous (SC), 50 mg, once weekly for 88 weeks

DRUG

Methotrexate

Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks. If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

DRUG

Etanercept

Subcutaneous (SC), 25 mg, once weekly from week 36 to week 88.

DRUG

Methotrexate

Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks. If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

DRUG

Placebo

Subcutaneous (SC), once weekly from week 36 to week 88.

DRUG

Methotrexate

Oral, 15 to 25 mg (varying based on dosage the subject is receiving at the time of screening and may be increased at the discretion of the investigator through Week 28 to a maximum of 25 mg/week), once weekly for 88 weeks. If a subject experiences an adverse event (AE) during the study, Methotrexate may be decreased by 2.5 or 5.0 mg weekly (the minimum dose to stay in the study is 10 mg/week).

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2011-05-31
Completion
2011-05-31

Countries

  • Australia
  • Austria
  • Belgium
  • Chile
  • Colombia
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Mexico
  • Netherlands
  • Poland
  • Russia
  • Serbia and Montenegro
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00565409 on ClinicalTrials.gov