NCT03161457|TerminatedPhase 1

Study Stopped

The development was stopped due to company's strategy consideration

A Study of JHL1101 Versus MabThera® in Subjects With Severe 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 Rheumatoid Arthritis (RA) on Background Methotrexate (MTX) Therapy

JHL Biotech, Inc.ClinicalTrials.gov

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1 other identifier

JHL-CLIN-1101-01

Study Type

interventional

Target

153

Locations

11 countries

Sites

Timeline

RegisteredMay 2017

StartedFeb 2017

CompletionApr 2019

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

153

participants targeted

Target at P75+ for phase_1 rheumatoid-arthritis

Timeline

Completed

Started Feb 2017

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach

11 countries

32 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

Study Start

First participant enrolled

February 27, 2017

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2017

Completed

28 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2019

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2019

Completed

Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

2.1 years

First QC Date

April 21, 2017

Last Update Submit

January 6, 2020

Conditions

Rheumatoid Arthritis Arthritis, Rheumatoid

Keywords

RAModerate RAModerate Rheumatoid ArthritisSevere RASevere Rheumatoid ArthritisModerate to Severe RAModerate to Severe Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

Area under plasma concentration versus time curve (AUC)
Day 0 through Week 52
Trough Concentration
Day 15
Maximum Concentration (Cmax)
Day 15

Secondary Outcomes (14)

AUC
Up to Week 12
Time to maximum plasma concentration
Day 0 through Week 52
Cmax
Day 0 through Week 52
Total body clearance
Day 0 through Week 52
Volume of distribution
Day 0 through Week 52
+9 more secondary outcomes

Study Arms (2)

JHL1101

EXPERIMENTAL

Each subject will receive 2 intravenous infusions of 1000 mg JHL1101: the first infusion on Baseline and the second on Day 15.

Biological: JHL1101

MabThera

ACTIVE COMPARATOR

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

Interventions

JHL1101BIOLOGICAL

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

JHL1101

MabTheraBIOLOGICAL

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

Also known as: Rituximab

MabThera

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

You may not qualify if:

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.
+6 more criteria

Contact the study team to confirm eligibility.