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A Study of Mavrilimumab in Subjects With Moderate-to-Severe Rheumatoid Arthritis

NCT01706926 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2016-09-27

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of 3 subcutaneous doses of mavrilimumab compared with placebo in combination with methotrexate (MTX) in subjects with moderate-to-severe adult onset Rheumatoid Arthritis (RA).

Conditions

Interventions

BIOLOGICAL

Mavrilimumab 30 mg

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks

BIOLOGICAL

Mavrilimumab 100 mg

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.

BIOLOGICAL

Mavrilimumab 150 mg

Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.

OTHER

Placebo

Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.

Sponsors & Collaborators

  • MedImmune Ltd

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Marius Albulescu, MD · MedImmune Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Argentina
  • Bulgaria
  • Chile
  • Colombia
  • Czechia
  • Estonia
  • Germany
  • Hungary
  • Poland
  • Russia
  • Serbia
  • South Africa
  • Spain
  • Ukraine

Study Locations

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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 NCT01706926 on ClinicalTrials.gov