Trial record 3 of 3 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03161457
Recruitment Status : Recruiting
First Posted : May 19, 2017
Last Update Posted : July 13, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Estimated Primary Completion Date : August 31, 2018
Estimated Study Completion Date : December 30, 2018

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

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

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 identifier (NCT number): NCT03161457

Contact: Peter Pang, PhD (886) 3 658 3899 ext 797
Contact: Alice Chen (886) 3 658 3899 ext 798

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Sponsors and Collaborators
JHL Biotech, Inc.

Responsible Party: JHL Biotech, Inc. Identifier: NCT03161457     History of Changes
Other Study ID Numbers: JHL-CLIN-1101-01
First Posted: May 19, 2017    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by JHL Biotech, Inc.:
Moderate RA
Moderate Rheumatoid Arthritis
Severe RA
Severe Rheumatoid Arthritis
Moderate to Severe RA
Moderate to Severe Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents