Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis

Conditions

• Rheumatoid Arthritis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Adalimumab - GP2017 — BIOLOGICAL
  Adalimumab - GP2017
• Adalimumab - US licensed Humira — BIOLOGICAL
  Adalimumab - US licensed Humira

Study Details

Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis

Key Dates

Start date

Mar 31, 2016

Status verified

Nov 2018

Primary completion

Jan 31, 2017

Completion

Sep 26, 2017

Study Design

Enrollment

353 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: GP2017
  Group 1 will receive treatment with 40mg GP2017 (Adalimumab - GP2017) by subcutaneous injection every other week up to 24 weeks (Study Period 1) at which patients achieving at least a moderate clinical response continue treatment with 40mg GP2017 subcutaneous injection every other week up to 48 weeks (Study Period 2).
• Active Comparator: US Licensed Humira
  Group 2 will receive treatment with 40mg Humira® (Adalimumab - US licensed Humira®) by subcutaneous injection every other week up to 24 weeks (Study Period 1) at which patients achieving at least a moderate clinical response will be switched to treatment with 40mg GP2017 subcutaneous injection every other week up to 48 weeks (Study Period 2).

Primary Outcome Measure

Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira [ Time Frame: Study period 1: week 12 ]

Locations (30)

Find similar trials in Mesa, AZ

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