Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02638259
• Date of registration: 16/12/2015
• Prospective Registration: No
• Primary sponsor: Sandoz
• Public title: Comparative Efficacy and Safety Study of GP2015 and Enbrel® in Patients With Rheumatoid Arthritis EQUIRA
• Scientific 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
• Date of first enrolment: February 21, 2015
• Target sample size: 376
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02638259
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Czech Republic, Czechia, Estonia, Germany, Hungary, Italy, Latvia, Lithuania, Mexico, Poland, Russian Federation, Serbia, Slovakia, Spain, United Kingdom, United States

Contacts

• Name: Arnd Schwebig, MD
• Affiliation: Global Program Medical Director

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: GP2015

Primary Outcome(s)

Safety: Change in DAS28-CRP Score From Baseline to Week 24 in Patients Treated With GP2015 and Patients Treated With Enbrel [Time Frame: treatment period 1: up to 24 weeks]

Secondary Outcome(s)

Treatment Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24; [Time Frame: Baseline, Weeks 4, 12 and 24;]

Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by CDAI [Time Frame: Weeks 4, 12 and 24;]

Treatment Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24; [Time Frame: Week 4, week 12 and week 24]

Treatment Period 1- Proportion of Patients Achieving HAQ Index in Normal Range (= 0.5) at Weeks 4, 12 and 24; [Time Frame: Weeks 4, 12 and 24;]

Treatment Period 2 : Changes From Baseline in DAS28-CRP and DAS28-ESR Scores From Week 4 up to Week 48 [Time Frame: week 4, week 12, week 24, week 36, week 48]

Safety : Overall Study: Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients [Time Frame: baseline, week 4, week 12, week 24, week 36, week 48]

Treatment Period 1: Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel [Time Frame: Treatment Period 1, up to 24 weeks]

Treatment Period 2 : CRP Levels at Week 36 and 48 [Time Frame: baseline, week 4, week 12, week 24, week 36, week 48]

Treatment Period 2 : Proportion of Patients Achieving DAS28 < 2.6 at Weeks 36 and 48; [Time Frame: week 36 and week 48]

Treatment Period 1 - Changes From Baseline in DAS28-CRP and DAS-ESR Scores to Weeks 4, 12 and 24 [Time Frame: baseline, Week 4, week 12, week 24]

Treatment Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria [Time Frame: week 4, week 12, week 24]

Treatment Period 1 - Proportion of Patients in Each Disease Activity Category as Defined by SDAI [Time Frame: Weeks 4, 12 and 24;]

Safety - Overall Study : Frequency and Severity of Injection Site Reactions in GP2015 and Enbrel [Time Frame: up to 48 weeks]

Treatment Period 1 - CRP Levels at Baseline and Weeks 4, 12 and 24 [Time Frame: Weeks 4, 12 and 24]

Treatment Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Weeks 36 and 48; [Time Frame: week 36 and week 48]

Treatment Period 1 - Safety : Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Positive Patients [Time Frame: baseline, week 2, week 4, week 12, week 24]

Treatment Period 1- DAS28-CRP and DAS28-erythrocyte Sedimentation Rate (ESR) Scores at Baseline and Weeks 4, 12 and 24; [Time Frame: week 4, 12, 24]

Treatment Period 1- Proportion of Patients Achieving EULAR Response [Time Frame: week 4, week 12 and week 24]

Treatment Period 2 : ACR-N Scores at Weeks 36 and 48; [Time Frame: week 36 and week 48]

Treatment Period 2 :Proportion of Patients Achieving HAQ Index in Normal Range (= 0.5) at Weeks 36 and 48; [Time Frame: baseline, week 4, week 12, week 24, week 36, week 48]

Treatment Period 1 - Health Assessment Questionnaire (HAQ) Index at Baseline, Weeks 4, 12 and 24; [Time Frame: Baseline, Weeks 4, 12 and 24;]

Treatment Period 2 : ESR Levels at Week 36 and 48 [Time Frame: baseline, week 4, week 12, week 24, week 36, week 48]

Treatment Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale Relative to Baseline at Weeks 36 and 48; [Time Frame: baseline, week 4, week 12, week 24, week 36, week 48]

Treatment Period 1- ACR-N Scores at Weeks 4, 12 and 24; [Time Frame: Weeks 4, 12 and 24;]

Treatment Period 2 : Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria [Time Frame: week 4, week 12, week 24, week 36, week 48]

Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by CDAI [Time Frame: baseline, week 4, week 12, week 24, week 36 and week 48]

Treatment Period 2 : Proportion of Patients in Each Disease Activity Category as Defined by SDAI [Time Frame: baseline, week 4, week 12, week 24, week 36. week 48]

Treatment Period 2: DAS28-CRP and DAS28-ESR Scores up to Week 48; [Time Frame: Baseline, week 4, week 12, week 24, week 36 and week 48.]

Treatment Period 2: Proportion of Patients Achieving EULAR Reponse [Time Frame: week 4, week 12, week 24, week 36 and week 48]

Treatment Period 1 - ESR Levels at Baseline and Weeks 4, 12 and 24 [Time Frame: Weeks 4, 12 and 24]

Treatment Period 1- Proportion of Patients Achieving DAS28 < 2.6 at Weeks 4, 12 and 24 [Time Frame: week 4, week 12 and week 24]

Treatment Period 2 :HAQ Index at Weeks 36 and 48; [Time Frame: baseline, week 4, week 12, week 24, week 36, week 48]

Secondary ID(s)

GP15-301

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 23/02/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02638259