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Study to Investigate the Safety and Efficacy of Tregalizumab in Subjects (MTX-IR) With Active Rheumatoid Arthritis

NCT01999192 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2017-08-24

Study results available
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Summary

The purpose of this study is to determine the efficacy and safety of three different Tregalizumab doses in combination with Methotrexate (MTX) in subjects who have active rheumatoid arthritis and an inadequate response to MTX alone.

The overall study duration is 24 weeks followed by a 24 week extension phase.

Conditions

Interventions

DRUG

Tregalizumab

humanized anti-CD4 mAb

DRUG

Placebo

identical end formulation buffer

Sponsors & Collaborators

  • AbbVie

    collaborator INDUSTRY

  • Biotest

    lead INDUSTRY

Principal Investigators

  • Ronald van Vollenhoven, Prof. MD · Karolinska Universitetssjukhuset, Solna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-07-31
Completion
2015-07-31

Countries

  • United States
  • Bulgaria
  • Canada
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Lithuania
  • Mexico
  • Poland
  • Russia
  • Serbia
  • Slovakia
  • Ukraine

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 NCT01999192 on ClinicalTrials.gov