NCT01394913

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_3 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
2 years until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 24, 2021

Status Verified

February 1, 2021

Enrollment Period

7 months

First QC Date

July 12, 2011

Last Update Submit

February 23, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Efficacy

    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)

    day 1 to day 210

Secondary Outcomes (1)

  • Safety

    day 1 to day 210

Study Arms (2)

Reumatocept 25mg

EXPERIMENTAL

50mg each week for 30 weeks

Drug: Reumatocept (etanercept)

Enbrel 25mg

ACTIVE COMPARATOR

50mg each week for 30 weeks

Drug: Enbrel (etanercept)

Interventions

Reumatocept (etanercept)DRUG

50mg each week for 30 weeks

Reumatocept 25mg
Enbrel (etanercept)DRUG

50mg each week for 30 weeks

Enbrel 25mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associação de Assitência à Criança Deficiente

São Paulo, 04038004, Brazil

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Study Officials

  • Felipe Pinho, MD

    EMS

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 15, 2011

Study Start

August 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2014

Last Updated

February 24, 2021

Record last verified: 2021-02

Locations

BR(1)