MedTrace Logo

A Study to Evaluate the Efficacy and Safety of CAM-3001 (Drug) in Subjects With Rheumatoid Arthritis

NCT01050998 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2018-06-25

Study results available
· View outcomes & findings →

Summary

The primary objectives of this study is to assess the safety, tolerability and efficacy of multiple doses of the mavrilimumab (CAM-3001) administered subcutaneously in subjects with moderately active Rheumatoid Arthritis (RA).

Conditions

Interventions

BIOLOGICAL

Mavrilimumab 10 mg

Mavrilimumab (CAM-3001) 10 mg injection subcutaneously every other week for 12 weeks.

BIOLOGICAL

Mavrilimumab 30 mg

Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks.

BIOLOGICAL

Mavrilimumab 50 mg

Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks.

BIOLOGICAL

Mavrilimumab 100 mg

Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks.

OTHER

Placebo

Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks.

Sponsors & Collaborators

  • MedImmune Ltd

    collaborator INDUSTRY

  • MedImmune LLC

    lead INDUSTRY

Principal Investigators

  • Marius Albulescu · 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
2010-01-05
Primary Completion
2011-06-09
Completion
2012-07-27

Countries

  • Bulgaria
  • Czechia
  • Estonia
  • Hungary
  • Japan
  • Latvia
  • Lithuania
  • Poland
  • Romania
  • Russia
  • Ukraine

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 NCT01050998 on ClinicalTrials.gov