Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatment gp2015
Phase phase 3
Sponsor Sandoz
Start date November 2015
End date January 2017
Trial size 376 participants
Trial identifier NCT02638259, GP15-301

Summary

Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
Arm
(Experimental)
Group 1 will receive treatment with 50mg GP2015 by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response continue treatment with 50mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).
gp2015
Enbrel comparator
(Active Comparator)
Group 2 will receive treatment with 50mg EU-authorized Enbrel by subcutaneous injection every week up to 24 weeks (Treatment Period 1) after which patients achieving at least a moderate clinical response will be switched to 50 mg GP2015 subcutaneous injection every week up to 48 weeks (Treatment Period 2).
gp2015
Enbrel comparator

Primary Outcomes

Measure
Change in DAS28-CRP score from baseline to week 24 in patients treated with GP2015 and patients treated with Enbrel
time frame: 24 weeks

Secondary Outcomes

Measure
Clinical safety as assessed by adverse events and other safety variables (vital signs and clinical laboratory variables).
time frame: 48 weeks
Local tolerability by assessing frequency and severity of injection site reactions
time frame: 48 weeks
Immunogenicity by measuring the rate of anti-drug antibody (ADA) positive patients
time frame: 48 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Patients at least 18 years of age with RA diagnosis according to ACR 1987 or ACR/EULAR 20110 criteria >/= 6 months at the time of baseline visit - Patient must have active disease defined as DAS28-CRP>/=3.2 - Patients must have CRP level above ULN >5mg/l) or erythrocyte sedimentation rate (ESR) >/=28mm/h - Patients must have inadequate clinical response to MTX at a dose of 10-25 mg/wk after proper dose escalation according to local standards Exclusion Criteria: - Previous exposure to etanercept in the past - Patients with functional status class IV according to the ACR 1991 revised criteria - History of active tuberculosis (TB) or Presence of latent (inactive)TB detected by imaging and/or by the QuantiFERON-TB Gold test at screening

Additional Information

Official title A Randomized, Double-blind, Parallel-group Phase III Study to Demonstrate Equivalent Efficacy and to Compare Safety & Immunogenicity of GP2015 and Enbrel® (EU Authorized) in Patients With Moderate to Severe, Active Rheumatoid Arthritis
Description Demonstrate equivalent efficacy of GP2015 and EU-authorized Enbrel in patients with moderate to severe, active (RA) who had an inadequate response to disease modifying anti-rheumatic drugs (DMARD) including methotrexate (MTX). In addition, data on the safety profiles of both products, including immunogenicity and local tolerability at the injection sites, will be collected and compared. An additional study objective is to identify any potential risk of the transition from Enbrel to GP2015 in terms of general safety and immunogenicity in RA patients
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Sandoz.