Clinical Trials List
Protocol NumberJHL-CLIN-1101-01
NCT Number(ClinicalTrials.gov Identfier)NCT03161457
2016-08-01 - 2020-12-31
Phase I
Terminated3
ICD-9714.0
Rheumatoid arthritis
A Randomised, Double-blind, Parallel Group, Multicentre Study to Compare the Pharmacokinetics, Pharmacodynamics, Immunogenicity, Safety, and Efficacy of JHL1101 versus EU sourced MabThera® in Anti TNF Inadequate Responder Patients with Moderate to Severe RA on Background MTX Therapy
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Trial Applicant
IQVIA RDS Taiwan Ltd.
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Sponsor
JHL Biotech, Inc.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tsung-Yun Hou 風濕免疫科
- 劉峰誠 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- CHENG-HAN WU 風濕免疫科
- CHIEH-YU SHEN 風濕免疫科
- KO-JEN LI 風濕免疫科
- 郭佑民 風濕免疫科
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Condition/Disease
Rheumatoid Arthritis (RA)
Objectives
This study will take place across approximately 31 centres across 12 countries and will randomise approximately 150 subjects as outpatients.
The primary objective is to investigate and compare the pharmacokinetic profiles of JHL1101 and MabThera (rituximab). The secondary objectives are to investigate the safety, tolerability, and immunogenicity of JHL1101 versus MabThera, to investigate the pharmacodynamics profile of JHL1101 versus MabThera, and investigate the efficacy of JHL1101 versus MabThera.
Test Drug
JHL1101
Active Ingredient
Rituximab
Dosage Form
Solution for IV infusion
Dosage
10mg/mL
Endpoints
Primary Outcome Measures :
1. Area under plasma concentration versus time curve (AUC) [ Time Frame: Day 0 through Week 52 ]
2. Trough Concentration [ Time Frame: Day 15 ]
3. Maximum Concentration (Cmax) [ Time Frame: Day 15 ]
Secondary Outcome Measures :
1. AUC [ Time Frame: Up to Week 12 ]
2. Time to maximum plasma concentration [ Time Frame: Day 0 through Week 52 ]
3. Cmax [ Time Frame: Day 0 through Week 52 ]
4. Total body clearance [ Time Frame: Day 0 through Week 52 ]
5. Volume of distribution [ Time Frame: Day 0 through Week 52 ]
6. Terminal half life [ Time Frame: Day 0 through Week 52 ]
7. Area under plasma concentration versus time curve [ Time Frame: Week 2 to Week 24 ]
8. Incidence of treatment-related adverse events (safety) [ Time Frame: Until End-of-Study follow-up at Week 52 ]
9. Immunogenicity [ Time Frame: Baseline, Weeks 12, 16, 24, and 52 ]
Human anti-chimeric antibody analysis
10. Area under the depletion-time curve of CD19+ B-cell [ Time Frame: Day 0 to Day 15, Day 0 to Week 12, Day 0 to Week 24, and Day 0 to Week 52 (end of study) ]
11. Change from Baseline in CD4+ T-cell counts [ Time Frame: Day 0 through Week 52 ]
12. American College of Rheumatology (ACR) criteria 20, 50, 70 response rate [ Time Frame: Weeks 4, 8, 12, 16, 24 and 52 and over time from Baseline to Week 52 ]
13. Swollen and tender joint count [ Time Frame: From Baseline to Week 52 ]
14. Subject's assessment of arthritis pain [ Time Frame: From Baseline to Week 52 ]
2010 ACR/European League Against Rheumatism (EULAR) Classification Criteria for RA
1. Area under plasma concentration versus time curve (AUC) [ Time Frame: Day 0 through Week 52 ]
2. Trough Concentration [ Time Frame: Day 15 ]
3. Maximum Concentration (Cmax) [ Time Frame: Day 15 ]
Secondary Outcome Measures :
1. AUC [ Time Frame: Up to Week 12 ]
2. Time to maximum plasma concentration [ Time Frame: Day 0 through Week 52 ]
3. Cmax [ Time Frame: Day 0 through Week 52 ]
4. Total body clearance [ Time Frame: Day 0 through Week 52 ]
5. Volume of distribution [ Time Frame: Day 0 through Week 52 ]
6. Terminal half life [ Time Frame: Day 0 through Week 52 ]
7. Area under plasma concentration versus time curve [ Time Frame: Week 2 to Week 24 ]
8. Incidence of treatment-related adverse events (safety) [ Time Frame: Until End-of-Study follow-up at Week 52 ]
9. Immunogenicity [ Time Frame: Baseline, Weeks 12, 16, 24, and 52 ]
Human anti-chimeric antibody analysis
10. Area under the depletion-time curve of CD19+ B-cell [ Time Frame: Day 0 to Day 15, Day 0 to Week 12, Day 0 to Week 24, and Day 0 to Week 52 (end of study) ]
11. Change from Baseline in CD4+ T-cell counts [ Time Frame: Day 0 through Week 52 ]
12. American College of Rheumatology (ACR) criteria 20, 50, 70 response rate [ Time Frame: Weeks 4, 8, 12, 16, 24 and 52 and over time from Baseline to Week 52 ]
13. Swollen and tender joint count [ Time Frame: From Baseline to Week 52 ]
14. Subject's assessment of arthritis pain [ Time Frame: From Baseline to Week 52 ]
2010 ACR/European League Against Rheumatism (EULAR) Classification Criteria for RA
Inclution Criteria
Inclusion Criteria:
• Moderate to severe active RA
• Documented intolerance to or inadequate response to at least 12 weeks of treatment with the licensed regimen of at least one TNF inhibitor therapy
• Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least twelve months after the last dose of study drug.
• Moderate to severe active RA
• Documented intolerance to or inadequate response to at least 12 weeks of treatment with the licensed regimen of at least one TNF inhibitor therapy
• Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least twelve months after the last dose of study drug.
Exclusion Criteria
Exclusion Criteria:
• History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the study drug including known hypersensitivity or allergy to a murine product
• Class IV as per the Classification of Global Functional Status in Rheumatoid Arthritis or wheelchair/bed-bound
• Have any significant systemic involvement with RA such as vasculitis, pulmonary fibrosis or Felty's syndrome
• History of or current inflammatory joint disease other than RA or other systemic disorder where the treatment or current or potential symptoms could confound the assessment of RA, with the exception of secondary Sjögren's syndrome
• Concomitant or recent DMARD treatments for RA
• Oral corticosteroids >10mg/day prednisone equivalent or dose which has not been stable for the 4 weeks prior to Baseline
• Receipt of an intra-articular or other injectable corticosteroid within 4 weeks prior to Screening
• Intolerance or contraindications to IV corticosteroids
• Use of NSAIDs which have not been at a stable dose within 2 weeks prior to Baseline.
• Have undergone surgical treatments for RA including synovectomy and arthroplasty in more than 3 joints and/or within the last 8 weeks prior to Screening
• History of major surgery within the 12 weeks prior to Screening
• History of an infected joint prosthesis which subsequently has not been surgically removed/replaced
• Positive serological test for HBsAg, hepatitis B core antibody or hepatitis C serology.
• History of HIV infection, or a positive test at Screening
• History of tuberculosis (TB) infection.
• Acute clinical manifestations of herpes zoster virus or herpes simplex.
• Active infection of any kind or any major episode of infection requiring hospitalization within 24 week prior to Baseline or requiring treatment with IV anti-infective agents within 8 weeks prior to Baseline or oral anti infective agents within 2 weeks prior to Baseline
• Subjects at risk of progressive multifocal leukoencephalopathy (PML) as per protocol
• Any significant cardiac disease
• Subjects with a history of solid-organ transplantation
• History of lympho- or myeloproliferative disorder or malignancy within the last 5 years
Other protocol-defined inclusion/exclusion criteria may apply.
• History of a severe allergic reaction or anaphylactic reaction to a biological agent or history of hypersensitivity to any component of the study drug including known hypersensitivity or allergy to a murine product
• Class IV as per the Classification of Global Functional Status in Rheumatoid Arthritis or wheelchair/bed-bound
• Have any significant systemic involvement with RA such as vasculitis, pulmonary fibrosis or Felty's syndrome
• History of or current inflammatory joint disease other than RA or other systemic disorder where the treatment or current or potential symptoms could confound the assessment of RA, with the exception of secondary Sjögren's syndrome
• Concomitant or recent DMARD treatments for RA
• Oral corticosteroids >10mg/day prednisone equivalent or dose which has not been stable for the 4 weeks prior to Baseline
• Receipt of an intra-articular or other injectable corticosteroid within 4 weeks prior to Screening
• Intolerance or contraindications to IV corticosteroids
• Use of NSAIDs which have not been at a stable dose within 2 weeks prior to Baseline.
• Have undergone surgical treatments for RA including synovectomy and arthroplasty in more than 3 joints and/or within the last 8 weeks prior to Screening
• History of major surgery within the 12 weeks prior to Screening
• History of an infected joint prosthesis which subsequently has not been surgically removed/replaced
• Positive serological test for HBsAg, hepatitis B core antibody or hepatitis C serology.
• History of HIV infection, or a positive test at Screening
• History of tuberculosis (TB) infection.
• Acute clinical manifestations of herpes zoster virus or herpes simplex.
• Active infection of any kind or any major episode of infection requiring hospitalization within 24 week prior to Baseline or requiring treatment with IV anti-infective agents within 8 weeks prior to Baseline or oral anti infective agents within 2 weeks prior to Baseline
• Subjects at risk of progressive multifocal leukoencephalopathy (PML) as per protocol
• Any significant cardiac disease
• Subjects with a history of solid-organ transplantation
• History of lympho- or myeloproliferative disorder or malignancy within the last 5 years
Other protocol-defined inclusion/exclusion criteria may apply.
The Estimated Number of Participants
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Taiwan
15 participants
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Global
150 participants
