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Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

NCT01578850 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 491

Last updated 2016-07-06

Study results available
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Summary

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

Conditions

Interventions

DRUG

Etanercept

etanercept 50mg once weekly + methotrexate with or without other DMARDs

DRUG

placebo

etanercept placebo once weekly + methotrexate with or without other DMARDs

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Brazil
  • China
  • Colombia
  • Czechia
  • Egypt
  • Hungary
  • Jordan
  • Lebanon
  • Malaysia
  • Mexico
  • Philippines
  • Qatar
  • Romania
  • Russia
  • South Africa
  • Taiwan
  • Thailand
  • Ukraine
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Drugs
Diseases
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 NCT01578850 on ClinicalTrials.gov