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

This study has suspended participant recruitment.
(Study suspended by decision strategically.)
Sponsor:
Information provided by (Responsible Party):
EMS
ClinicalTrials.gov Identifier:
NCT01394913
First received: July 12, 2011
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Rheumatoid Arthritis
Drug: Reumatocept (etanercept)
Drug: Enbrel (etanercept)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Double-blind, Randomized Study to Compare Efficacy of Two Etanercept Regimens (REUMATOCEPT® Versus ENBREL®) for Treatment of Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by EMS:

Primary Outcome Measures:
  • Efficacy [ Time Frame: day 1 to day 210 ] [ Designated as safety issue: Yes ]
    1. Health Assessment Questionnaire (HAQ)
    2. Disease Activity Score (DAS28)
    3. Clinical Disease Activity Index (CDAI)
    4. American College of Rheumatology criteria (ACR)
    5. Visual Activity Schedule(VAS)


Secondary Outcome Measures:
  • Safety [ Time Frame: day 1 to day 210 ] [ Designated as safety issue: Yes ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability


Estimated Enrollment: 216
Study Start Date: August 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reumatocept 25mg
50mg each week for 30 weeks
Drug: Reumatocept (etanercept)
50mg each week for 30 weeks
Active Comparator: Enbrel 25mg
50mg each week for 30 weeks
Drug: Enbrel (etanercept)
50mg each week for 30 weeks

Detailed 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
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must be able to understand the study procedures agree to participate and give written consent.
  2. Patients with clinical diagnosis of moderate to severe rheumatoid arthritis according to 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 Criteria:

  1. Pregnancy and Lactation
  2. Patients with uncontrolled hypertension
  3. Patients with other rheumatic disease such as Sjogren syndrome, systemic lupus erythematosus 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 the disqualification of the individual from study participation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01394913

Locations
Brazil
Associação de Assitência à Criança Deficiente
Sao Paulo, Brazil, 04038004
Sponsors and Collaborators
EMS
Investigators
Study Director: Felipe Pinho, MD EMS
  More Information

No publications provided

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01394913     History of Changes
Other Study ID Numbers: ETAEMS0411
Study First Received: July 12, 2011
Last Updated: March 1, 2013
Health Authority: Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Immunoglobulin G
TNFR-Fc fusion protein
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Gastrointestinal Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014