Overview

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

Status:
Completed
Trial end date:
0000-00-00
Target enrollment:
291
Participant gender:
Both
Summary
To assess the safety, tolerability and efficacy of multiple doses of the drug, CAM-3001 administered in patients with moderately active Rheumatoid Arthritis.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MedImmune LLC
Collaborator:
MedImmune Ltd
Last Updated:
2014-01-13
Criteria
Inclusion Criteria:

Age 18 through 80 years (20 to 75 years in Japan) Diagnosis of adult onset Rheumatoid
Arthritis of at least 3 months Functional class I-III defined by the 1992 ACR
Classification of Functional Status in RA (Hochberg et al, 1992) Treatment with
methotrexate at a stable dose

Exclusion Criteria:

A rheumatic autoimmune disease other than RA. Subjects at a high risk of infection
Pregnancy Subjects (male and female) of reproductive potential who are not willing to use
contraception from screening through the end date of the trial