Phase 3
Completed N=645
A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients
Arthritis, Rheumatoid
Source: ClinicalTrials.gov NCT02405780 ↗
Enrolled (actual)
645
Serious AEs
6.1%
Results posted
Mar 2019
Primary outcomePrimary: Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I — 0; 0; 1; 1 participants
◆ Published Evidence
Established
54citations · ~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 long-term safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and 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 Number of Patients With Adverse Events as a Measure of Safety Per Treatment Group in Period I |
0; 0; 1; 1; 0; 0 | — |
| PRIMARY Number of Patients With Adverse Events as a Measure of Safety in Period II - Single Treatment Period |
2; 2; 340; 19; 126; 25 | — |
| PRIMARY Number of Patients With Serious Adverse Events as a Measure of Safety Per Treatment Group in Period I |
0; 0; 1; 1; 0; 0 | — |
| PRIMARY Number of Patients With Serious Adverse Events as a Measure of Safety in Period II - Single Treatment Period |
2; 2; 19; 10; 6; 33 | — |
| PRIMARY Changes in Vital Signs as a Measure of Safety - Systolic Blood Pressure |
125.0; 125.5; 131.0; 129.0; 125.0; 123.5 | — |
| PRIMARY Changes in Vital Signs as a Measure of Safety - Diastolic Blood Pressure |
78.0; 78.0; 80.0; 77.0; 78.0; 75.0 | — |
| PRIMARY Changes in Vital Signs as a Measure of Safety - Pulse Rate |
74.0; 74.0; 74.0; 74.0; 72.0; 71.0 | — |
| PRIMARY Changes in Vital Signs as a Measure of Safety - Temperature Measurements |
36.600; 36.600; 36.600; 36.500; 36.500; 36.500 | — |
| PRIMARY Summary of Most Common Clinical Significant Laboratory Parameters Reported as Adverse Events (Reported by ≥1% of the Patients) |
3; 1; 2; 3; 11; 3 | — |
| SECONDARY Changes in Disease Activity Score 28 Based on C Reactive Protein (DAS28 CRP) Score Compared to Baseline as a Measure of Efficacy |
6.02; 6.12; 5.99; 6.11; 3.46; 3.49 | — |
| SECONDARY American College of Rheumatology 20 (ACR20) Response Rates From Baseline as a Measure of Efficacy |
163; 87; 82; 175; 171; 83 | — |
| SECONDARY American College of Rheumatology 50 (ACR50) Response Rates From Baseline as a Measure of Efficacy |
104; 52; 50; 109; 110; 50 | — |
| SECONDARY American College of Rheumatology 70 (ACR70) Response Rates From Baseline as a Measure of Efficacy |
45; 23; 23; 56; 54; 30 | — |
Eligibility Criteria
Inclusion Criteria
- Patient has completed the Week 24 visit procedures of Study FKB327-002 (NCT02260791) and are continuing with methotrexate
- In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002 (NCT02260791)
Exclusion Criteria
- Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002
- Patient has presence of active and/or untreated latent tuberculosis (TB)
Other Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02405780) 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.