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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03161457
• Date of registration: 21/04/2017
• Prospective Registration: No
• Primary sponsor: JHL Biotech, Inc.
• Public title: A Study of JHL1101 Versus MabThera® in Subjects With Severe Rheumatoid Arthritis
• Scientific 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
• Date of first enrolment: February 27, 2017
• Target sample size: 153
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03161457
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Bosnia and Herzegovina, Bulgaria, Czechia, Germany, Hungary, Lithuania, Poland, Russian Federation, Taiwan, Ukraine, United Kingdom

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Arthritis, Rheumatoid

Intervention(s)

Biological: MabThera

Biological: JHL1101

Primary Outcome(s)

Area under plasma concentration versus time curve (AUC) [Time Frame: Day 0 through Week 52]

Trough Concentration [Time Frame: Day 15]

Maximum Concentration (Cmax) [Time Frame: Day 15]

Secondary Outcome(s)

Change from Baseline in CD4+ T-cell counts [Time Frame: Day 0 through Week 52]

Cmax [Time Frame: Day 0 through Week 52]

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]

Area under plasma concentration versus time curve [Time Frame: Week 2 to Week 24]

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)]

AUC [Time Frame: Up to Week 12]

Immunogenicity [Time Frame: Baseline, Weeks 12, 16, 24, and 52]

Incidence of treatment-related adverse events (safety) [Time Frame: Until End-of-Study follow-up at Week 52]

Time to maximum plasma concentration [Time Frame: Day 0 through Week 52]

Swollen and tender joint count [Time Frame: From Baseline to Week 52]

Terminal half life [Time Frame: Day 0 through Week 52]

Subject's assessment of arthritis pain [Time Frame: From Baseline to Week 52]

Total body clearance [Time Frame: Day 0 through Week 52]

Volume of distribution [Time Frame: Day 0 through Week 52]

Secondary ID(s)

JHL-CLIN-1101-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors