Phase 3
Completed N=728
A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02260791 ↗
Enrolled (actual)
728
Serious AEs
4.7%
Results posted
Sep 2017
Primary outcomePrimary: American College of Rheumatology (ACR) 20 Response Rate — 72.5; 74.3 Percentage of participants
◆ Published Evidence
Established
53citations · ~11 / year
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
Summary
The purpose of the study is to compare the effectiveness and safety of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have inadequate disease control on methotrexate.
Linked Publications (2)
-
Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity.
-
FKB327, an adalimumab biosimilar, versus the reference product: results of a randomized, Phase III, double-blind study, and its open-label extension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American College of Rheumatology (ACR) 20 Response Rate |
72.5; 74.3 | — |
| SECONDARY Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score |
6.05; 6.06; 4.92; 4.86; 4.44; 4.43 | — |
| SECONDARY ACR20 Response Rates Over Time |
37.3; 31; 51; 52.4; 64.6; 67.7 | — |
| SECONDARY ACR50 Response Rates Over Time |
5; 8.8; 17.3; 17.8; 28.9; 30.9 | — |
| SECONDARY ACR70 Response Rates Over Time |
0.3; 2.3; 4.5; 6.9; 11.3; 10.7 | — |
| SECONDARY Swollen Joint Count |
16.3; 16; 3.8; 3.5 | — |
| SECONDARY Tender Joint Count |
26.2; 25.9; 8.5; 8.1 | — |
| SECONDARY Analysis of Serum C-Reactive Protein (CRP) Concentration |
25.12; 26.73; 10.98; 11.78 | — |
| SECONDARY Patient Assessment of Disease Activity |
68; 68.2; 35.2; 33.2 | — |
| SECONDARY Physician Assessment of Disease Activity |
68.4; 66.2; 21.5; 21.5 | — |
| SECONDARY Patient's Assessment of Pain |
66.8; 67.7; 34.7; 33.6 | — |
| SECONDARY Health Assessment Questionnaire Disability Index (HAQ-DI) |
1.78; 1.8; 1.21; 1.26 | — |
| SECONDARY DAS28-CRP Score Over Time |
6.05; 6.06; 3.47; 3.47 | — |
| SECONDARY DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR) |
6.52; 6.56; 4.24; 4.24; 3.82; 3.85 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female aged 18 years or over
- Patients have been diagnosed with Rheumatoid Arthritis (RA) for at least 3 months
- Patient has active RA
- Patient has taken a stable dose of methotrexate for at least 3 months
Exclusion Criteria
- Patient has been previously treated with adalimumab
- Patient has been previously treated or has ongoing treatment with prohibited medications
- Patient has been immunised with a live or attenuated vaccine in past 4 weeks
- Patient has positive result for HIV, HBV, HCV or TB infection
Other Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02260791) 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.