Phase 3
Completed N=353
Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT02744755 ↗Enrolled (actual)
353
Serious AEs
3.5%
Results posted
Dec 2018
Primary outcomePrimary: Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira — -2.16; -2.18 scores on a scale
◆ Published Evidence
Established
53citations · ~11 / year
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
Summary
Clinical trial to compare treatment with GP2017 and Humira® in patients with Rheumatoid Arthritis
Linked Publications (3)
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Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
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Switching to Biosimilar SDZ-ADL in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: 48-Week Efficacy, Safety and Immunogenicity Results From the Phase III, Randomized, Double-Blind ADMYRA Study.
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Treatment with SDZ-ADL, an Adalimumab Biosimilar, in Patients with Rheumatoid Arthritis, Psoriasis, or Psoriatic Arthritis: Results of Patient-Reported Outcome Measures from Two Phase III Studies (ADMYRA and ADACCESS).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Study Period 1: Change in DAS28-CRP Score From Baseline at Week 12 in Patients Treated With GP2017 and Patients Treated With Humira |
-2.16; -2.18 | — |
| SECONDARY Study Period 1: Time-weighted Averaged Change From Baseline in DAS28-CRP Until Week 24 in Patients Treated With GP2017 and With Humira |
-1.85; -1.93 | — |
| SECONDARY Study Period 1- Proportion of Patients Achieving EULAR Criterion for Remission |
15; 7; 32; 38; 49; 71 | — |
| SECONDARY Study Period 1- Proportion of Patients Achieving EULAR Criterion for Good Response |
22; 25; 51; 63; 76; 93 | — |
| SECONDARY Study Period 1- Proportion of Patients Achieving EULAR Criterion for Moderate Response |
63; 78; 64; 62; 42; 42 | — |
| SECONDARY Study Period 1- Proportion of Patients Achieving EULAR/ACR Boolean Remission Criteria |
4; 0; 8; 12; 19; 26 | — |
| SECONDARY Study Period 1: Change in DAS28-CRP and DAS28-ESR Scores From Baseline to Week 24 in Patients Treated With GP2017 and Patients Treated With Humira |
-0.86; -0.92; -1.31; -1.36; -2.61; -2.83 | — |
| SECONDARY Study Period 1- Proportion of Patients Achieving ACR20/50/70 Response at Weeks 4, 12 and 24 |
64; 71; 100; 106; 111; 130 | — |
| SECONDARY Study Period 1 - Changes From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI©) at Weeks 4, 12 and 24; |
-0.32; -0.32; -0.50; -0.47; -0.63; -0.59 | — |
| SECONDARY Study Period 1- Proportion of Patients Achieving HAQ-DI© in Normal Range (≤ 0.5) at Weeks 4, 12 and 24; |
27; 33; 38; 40; 46; 50 | — |
| SECONDARY Study Period 1- Proportion of Patients Achieving HAQ-DI© Score Improvement >0.3 at Weeks 4, 12 and 24 |
106; 117; 102; 109; 91; 106 | — |
| SECONDARY Study Period 1 - Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Relative to Baseline at Weeks 4, 12 and 24 (Change From Baseline) |
6.59; 7.25; 10.49; 10.62; 12.57; 12.72 | — |
| SECONDARY Study Period 1 - CRP (C-reactive Protein) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24 |
-4.79; -4.93; -5.98; -5.07; -2.51; -5.30 | — |
| SECONDARY Study Period 1 -ESR (Erythrocyte Sedimentation Rate) Changes From Baseline in GP2017 and US-licensed Humira Treated at Weeks 4, 12 and 24 |
-16.17; -13.98; -17.33; -15.08; -19.60; -20.49 | — |
| SECONDARY Study Period 1: Incidence and Severity of Injection Site Reactions in GP2017 and Humira |
7; 11; 7; 7; 0; 4 | — |
| SECONDARY Study Period 1 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 or Humira (Positive Patients) |
10; 6; 12; 10; 14; 22 | — |
| SECONDARY Study Period 2 - Immunogenicity by Measuring the Rate of Anti-drug Antibody (ADA) Formation Against Adalimumab in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira (Positive Patients) |
22; 25; 21; 22; 12; 12 | — |
| SECONDARY Study Period 2 : Proportion of Patients Achieving ACR20/50/70 Response at Week 48, in Patients Treated With GP2017 Who Continued GP2017 or Switched to GP2017 From Humira |
93; 111; 72; 81; 49; 55 | — |
| SECONDARY Study Period 2 - Health Assessment Questionnaire-Disability Index (HAQ-DI©) Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira |
0.01; -0.03 | — |
| SECONDARY Study Period 2 :Proportion of Patients Treated Continuously With GP2017 and Patients Treated With GP2017 After Switch From Humira Achieving HAQ-DI© Score in Normal Range ≤0.5 at Week 48 |
45; 52 | — |
| SECONDARY Study Period 2 : Functional Assessment of Chronic Illness Therapy (FACIT©) Fatigue Scale Changes From Week 24 at Week 48 in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira |
-0.65; -0.85 | — |
| SECONDARY Study Period 2: Changes From Week 24 at Week 48 in DAS28-CRP and DAS28-ESR Scores in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira |
-0.10; 0.00; -0.04; 0.00 | — |
| SECONDARY Study Period 2: Incidence of Injection Site Reactions in Patients Treated Continuously With GP2017 and in Patients Treated With GP2017 After Switch From Humira |
1; 2; 1; 2; 0; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Patients must have been diagnosed with RA ≥ 6 months prior to screening
- Patients must have active disease, defined as DAS28-CRP ≥ 3.2 at the time of screening
- Patients must have CRP levels above 5mg/l or ESR levels above the upper limits of normal
- Patients must have had inadequate clinical response to MTX 10 - 25 mg/week
Exclusion Criteria
- Previous treatment with adalimumab, other anti-TNFα therapies or cell depleting agents, e.g. anti-CD20 therapy
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during treatment
- Nursing (lactating) or pregnant women
- History of or ongoing inflammatory or autoimmune diseases other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
- Systemic corticosteroids > 7.5mg/day within 4 weeks prior to baseline
- History or presence of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix and/or removed non-invasive colon polyps, with no evidence of recurrence
- History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months)
- Subject known to have immune deficiency, history of positive human immunodeficiency virus (HIV) status or immunocompromised for other reasons
- History of clinically significant hematologic (e.g. severe anemia, leucopenia, thrombocytopenia), renal or liver disease (e.g. glomerulonephritis, fibrosis, cirrhosis, hepatitis)
- History of persistent chronic infection; recurrent infection or active infections
- History of tuberculosis, presence of active tuberculosis, latent tuberculosis as detected by imaging (e.g. chest X-ray, chest Computerized Tomography(CT) scan, Magnetic Resonance Imaging (MRI)) and/ or positive QuantiFERON-TB Gold test (QFT)
- History or evidence of opportunistic infections, e.g. histoplasmosis, listeriosis, legionellosis
- Positive serology Hepatitis B (either HBsAg or anti-HBc) or Hepatitis C (positive HCV-Ab or HCV-RNA) indicative of previous or current infections
Data sourced from ClinicalTrials.gov (NCT02744755) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.