A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy

Sponsor
Samsung Bioepis Co., Ltd.
Study ID
NCT02167139
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.

Key Dates

Start date
May 31, 2014
Status verified
Nov 2016
Primary completion
Apr 30, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
544 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SB5 (proposed biosimilar to adalimumab)
    SB5 40 mg every other week via subcutaneous injection
  • Active Comparator: Humira (adalimumab)
    Humira 40 mg every other week via subcutaneous injection

Primary Outcome Measure

American College of Rheumatology 20% Response Criteria (ACR20) [ Time Frame: Week 24 ]

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