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

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ClinicalTrials.gov Identifier: NCT01394913
Recruitment Status : Suspended (Study suspended by decision strategically.)
First Posted : July 15, 2011
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
EMS

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

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Reumatocept (etanercept) Drug: Enbrel (etanercept) Phase 3

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : August 2013
Estimated Primary Completion Date : March 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Etanercept
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Efficacy [ Time Frame: day 1 to day 210 ]
    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 :
  1. Safety [ Time Frame: day 1 to day 210 ]
    Adverse events will be collected and followed in order to evaluate safety and tolerability



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01394913


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

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01394913     History of Changes
Other Study ID Numbers: ETAEMS0411
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Etanercept
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors