We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov Menu

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

This study has suspended participant recruitment.
(Study suspended by decision strategically.)
ClinicalTrials.gov Identifier:
First Posted: July 15, 2011
Last Update Posted: March 4, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
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
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

Resource links provided by NLM:

Further study details as provided by EMS:

Primary Outcome Measures:
  • 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:
  • Safety [ Time Frame: day 1 to day 210 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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

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

Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT01394913     History of Changes
Other Study ID Numbers: ETAEMS0411
First Submitted: July 12, 2011
First Posted: July 15, 2011
Last Update Posted: March 4, 2013
Last Verified: March 2013

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