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GP2013 in the Treatment of RA Patients Refractory to or Intolerant of Standard Therapy

NCT01274182 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2018-01-24

Study results available
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Summary

The purpose of this study is to determine the PK/PD, efficacy and safety of GP2013 in patients with severe rheumatoid arthritis.

Conditions

Interventions

BIOLOGICAL

GP2013

1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)

BIOLOGICAL

MabThera

1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)

BIOLOGICAL

Rituxan

1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)

Sponsors & Collaborators

Principal Investigators

  • Sandoz Biopharmaceuticals · Sandoz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2016-01-31
Completion
2016-11-30

Countries

  • United States
  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Estonia
  • France
  • Germany
  • Hungary
  • India
  • Italy
  • Romania
  • Spain
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT01274182 on ClinicalTrials.gov