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

EMS

Status and phase: Withdrawn; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Reumatocept (etanercept); Drug: Enbrel (etanercept)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01394913

ETAEMS0411

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Reumatocept 25mg

Experimental group

Description:

50mg each week for 30 weeks

Treatment:

Drug: Reumatocept (etanercept)

Enbrel 25mg

Active Comparator group

Description:

50mg each week for 30 weeks

Treatment:

Drug: Enbrel (etanercept)