Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 58 for:    JHL1101

A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03161457
Recruitment Status : Terminated (The development was stopped due to company's strategy consideration)
First Posted : May 19, 2017
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
JHL Biotech, Inc.

Brief Summary:
This is a multicentre, randomised, double-blind, parallel group study to compare the pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, safety, tolerability and efficacy of JHL1101 versus MabThera in subjects with moderate to severe RA who have previously failed at least 1 tumour necrosis factor alpha (TNF) inhibitor (i.e., intolerance or documented active disease despite at least 12 weeks treatment according to the TNF inhibitor-approved treatment and dosage), and are on concomitant treatment with MTX.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Arthritis, Rheumatoid Biological: JHL1101 Biological: MabThera Phase 1

Detailed Description:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) Therapy
Actual Study Start Date : February 27, 2017
Actual Primary Completion Date : April 16, 2019
Actual Study Completion Date : April 16, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Rituximab

Arm Intervention/treatment
Experimental: JHL1101
Each subject will receive 2 intravenous infusions of 1000 mg JHL1101: the first infusion on Baseline and the second on Day 15.
Biological: JHL1101
1000 mg containing 10 mg/mL rituximab to be diluted to a concentration of 1 to 4 mg/mL in 0.9% normal saline or 5% D-glucose for administration

Active Comparator: MabThera
Each subject will receive 2 intravenous infusions of 1000 mg MabThera: the first infusion on Baseline and the second on Day 15 (Visit 5).
Biological: MabThera
1000 mg containing 10 mg/mL rituximab to be diluted to a concentration of 1 to 4 mg/mL in 0.9% normal saline or 5% D-glucose for administration
Other Name: Rituximab




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161457


Locations
Layout table for location information
Bosnia and Herzegovina
JHL Biotech Investigational Site
Banja Luka, Bosnia and Herzegovina, 78000
JHL Biotech Investigational Site
Bijeljina, Bosnia and Herzegovina, 76300
Bulgaria
JHL Biotech Investigational Site
Plovdiv, Bulgaria, 4002
JHL Biotech Investigational Site
Sofia, Bulgaria, 1336
JHL Biotech Investigational Site
Sofia, Bulgaria, 1612
Czechia
JHL Biotech Investigational Site
Praha, Czechia, 14059
Germany
JHL Biotech Investigational Site
Bad Doberan, Germany, 18209
JHL Biotech Investigational Site
Hildesheim, Germany, 31134
JHL Biotech Investigational Site
Magdeburg, Germany, 39120
JHL Biotech Investigational Site
Rendsburg, Germany, 24768
Hungary
JHL Biotech Investigational Site
Budapest, Hungary, 1027
Lithuania
JHL Biotech Investigational Site
Vilnius, Lithuania, LT-08661
Poland
JHL Biotech Investigational Site
Poznan, Poland, 61-113
JHL Biotech Investigational Site
Wroclaw, Poland, 50-420
Russian Federation
JHL Biotech Investigational Site
Kazan', Russian Federation, 420103
JHL Biotech Investigational Site
Moscow, Russian Federation, 111539
JHL Biotech Investigational Site
Moscow, Russian Federation, 119049
JHL Biotech Investigational Site
Saint Petersburg, Russian Federation, 197341
JHL Biotech Investigational Site
Saint Petersburg, Russian Federation, 197342
JHL Biotech Investigational Site
Samara, Russian Federation, 443095
JHL Biotech Investigational Site
Saratov, Russian Federation, 410026
JHL Biotech Investigational Site
Yaroslavl', Russian Federation, 150062
Taiwan
JHL Biotech Investigational Site
Taichung, Taiwan, 402
JHL Biotech Investigational Site
Taipei, Taiwan, 100
JHL Biotech Investigational Site
Taipei, Taiwan, 11490
Ukraine
JHL Biotech Investigational Site
Kharkiv, Ukraine, 61039
JHL Biotech Investigational Site
Kyiv, Ukraine, 03680
JHL Biotech Investigational Site
L'viv, Ukraine, 79010
JHL Biotech Investigational Site
Poltava, Ukraine, 36011
JHL Biotech Investigational Site
Vinnytsya, Ukraine, 21018
United Kingdom
JHL Biotech Investigational Site
London, United Kingdom, E11 1NR
JHL Biotech Investigational Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
JHL Biotech, Inc.
Layout table for additonal information
Responsible Party: JHL Biotech, Inc.
ClinicalTrials.gov Identifier: NCT03161457    
Other Study ID Numbers: JHL-CLIN-1101-01
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by JHL Biotech, Inc.:
RA
Moderate RA
Moderate Rheumatoid Arthritis
Severe RA
Severe Rheumatoid Arthritis
Moderate to Severe RA
Moderate to Severe Rheumatoid Arthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Rituximab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents