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

NCT03161457 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2020-01-09

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • JHL Biotech, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-27
Primary Completion
2019-04-16
Completion
2019-04-16

Countries

  • Bosnia and Herzegovina
  • Bulgaria
  • Czechia
  • Germany
  • Hungary
  • Lithuania
  • Poland
  • Russia
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03161457 on ClinicalTrials.gov