A Study to Compare FKB327 Efficacy and Safety With Humira® in Rheumatoid Arthritis Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Randomised, Blinded, Active-Controlled Study to Compare FKB327 Efficacy and Safety With the Comparator Humira® in Rheumatoid Arthritis Patients Inadequately Controlled on Methotrexate

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: FKB327
* Drug: Humira®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FKB327<br>Patients will receive FKB327 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks. | Drug: FKB327<br>* Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.<br>|
| Active Comparator: Humira®<br>Patients will receive Humira® 40 mg every other week by subcutaneous injection. The treatment period will continue for 22 weeks. | Drug: Humira®<br>* Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology (ACR) 20 Response Rate | The primary efficacy endpoint was the ACR20 response rate at Week 24. An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI]) | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score 28 (DAS28) Based on C-reactive Protein (DAS28-CRP) Score | The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The DAS28-CRP is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity. | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | 
| ACR20 Response Rates Over Time | An ACR20 response meant that the patient achieved a 20% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health Assessment Questionnaire Disability Index [HAQ-DI]) | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | 
| ACR50 Response Rates Over Time | An ACR50 response meant that the patient achieved a 50% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI]) | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | 
| ACR70 Response Rates Over Time | An ACR70 response meant that the patient achieved a 70% improvement in Tender Joint Count and Swollen Joint Count and in at least 3 of the other 5 Core Data Set elements listed below. Acute phase reactant (CRP) Patient global assessment of disease activity Physician global assessment of disease activity Patient pain scale Disability/functional questionnaire (patient completed Health AssessmentQuestionnaire Disability Index [HAQ-DI]) | Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24 | 
| Swollen Joint Count | Counts of swollen joints from amongst 66 selected joints performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66 with higher scores indicating severe disease. Swollen joint count is a value of the individual ACR core set variables. | Baseline and Week 24 | 
| Tender Joint Count | Counts of tender joints from amongst 68 selected joints were performed by a trained and qualified joint assessor using standardised techniques recommended by the European League Against Rheumatism (EULAR). Joints were classified as tender/not tender giving a total possible tender joint count score of 0 to 68 with higher scores indicating severe disease.Tender joint count is a value of the individual ACR core set variables. | Baseline and Week 24 | 
| Analysis of Serum C-Reactive Protein (CRP) Concentration | Analysis of serum C-Reactive Protein (CRP) concentrations for inclusion in the ACR20/50/70 and DAS28-CRP scores was performed by a central laboratory. Elevation of CRP is a nonspecific marker of inflammation. Values above 10 mg/L were considered to be abnormally high. Decrease in level of CRP indicates reduction in inflammation. | Baseline and Week 24 | 
| Patient Assessment of Disease Activity | Patient assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scales (ranging from very well (0) to extremely bad (100)).The patient assessment of disease activity VAS will contribute to the calculation of the DAS28 score. The patient assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response. | Baseline and Week 24 | 
| Physician Assessment of Disease Activity | Physician assessment of disease activity visual analogue scale (VAS) will be assessed on 100-point scale (ranging from very low (0) to very high (100)). The physician assessment of disease activity VAS will contribute to the calculation of ACR20, ACR50 and ACR70 response. | Baseline and Week 24 | 
| Patient's Assessment of Pain | An injection site pain visual analogue score (VAS) will be administered to the patient. To determine the extent of the pain, patients will be asked to place a small vertical mark on a horizontal scale from 0 to 100, the ends of which are labelled with the extreme responses to be measured (No pain at 0 and Intolerable pain at 100). Patient's assessment of pain is a value of the individual ACR core set variables. | Baseline and Week 24 | 
| Health Assessment Questionnaire Disability Index (HAQ-DI) | The HAQ-DI is a 20-question, self-administered instrument that measures the patient's functional ability on a 4-level difficulty scale (0 to 3, with 0 representing normal or no difficulty and 3 representing inability to perform). Eight categories of functioning are included: dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. This scale is sensitive to change and is a good predictor of future disability. HAQ-DI is a value of the individual ACR core set variables. | Baseline and Week 24 | 
| DAS28-CRP Score Over Time | The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-CRP assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum CRP, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity. | Baseline and Week 24 | 
| DAS28 Score Based on Erythrocyte Sedimentation Rate (DAS28-ESR) | The DAS28 score is a combined index that has been developed to measure the disease activity in patients with RA and has been extensively validated for its use in clinical studies. The DAS28-ESR assessment involved evaluating the number of tender (TJC) and swollen (SJC) joints (out of 28 specified joints), serum ESR, and patient global assessment of disease activity (VAS from 0 to 100, very well to extremely bad). The individual results are summed using a formula. The DAS28 is a number on a scale from 0 to 10 indicating the current activity of the patient's RA. A higher score indicates higher disease activity. | Baseline, Week 12 and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid, Arthritis