Comparison of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis

Last updated: February 23, 2021
Sponsor: EMS
Overall Status: Trial Not Available

Phase

3

Condition

Joint Injuries

Arthritis And Arthritic Pain

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT01394913
ETAEMS0411
  • Ages 18-70
  • All Genders

Study Summary

This study is a comparison of safety and efficacy of two etanercept regimens (REUMATOCEPT® versus ENBREL®) for treatment of Rheumatoid Arthritis.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients must be able to understand the study procedures agree to participate and givewritten consent.
  2. Patients with clinical diagnosis of moderate to severe rheumatoid arthritis accordingto American College of Rheumatology (ACR) criteria;
  3. Patients with at least 6 swollen joints
  4. Patients with partial response in treatment with methotrexate for 2 months

Exclusion

Exclusion Criteria:

  1. Pregnancy and Lactation
  2. Patients with uncontrolled hypertension
  3. Patients with other rheumatic disease such as Sjogren syndrome, systemic lupuserythematosus or spondyloarthritis
  4. Non-steroidal anti-inflammatory drug in the last 4 weeks
  5. Any pathology or past medical condition that can interfere with this protocol
  6. Patients with immunodeficiency and/or immunosuppressive disease;
  7. Other conditions deemed reasonable by the medical investigator as to thedisqualification of the individual from study participation.

Study Design

Study Start date:
August 01, 2013
Estimated Completion Date:
June 30, 2014

Study Description

Study design:

• Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.

Study design:

  • Experiment duration: 30 weeks

  • 9 visits (days 0, 14, 42, 70, 98, 126, 154, 182, 210)

  • Health Assessment Questionnaire (HAQ) evaluation

  • Disease Activity Score (DAS28) evaluation

  • Clinical Disease Activity Index (CDAI) evaluation

  • American College of Rheumatology criteria (ACR) evaluation

  • Visual Activity Schedule(VAS) evaluation

  • Adverse events evaluation

Connect with a study center

  • Associação de Assitência à Criança Deficiente

    Sao Paulo, 04038004
    Brazil

    Site Not Available

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