A Phase 2 Proof-of-Concept Study of Gevokizumab in Active Inflammatory, Erosive Osteoarthritis of the Hand
Placebo
+ gevokizumab
Arthritis+2
+ Joint Diseases
+ Musculoskeletal Diseases
Treatment Study
Summary
Study start date: July 1, 2012
Actual date on which the first participant was enrolled.The purpose of this proof-of-concept study is to determine whether gevokizumab is effective in the treatment of active inflammatory, erosive osteoarthritis of the hand.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.87 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: Diagnosis of hand osteoarthritis Joint tenderness and/or redness At least one erosion by X-ray (as determined by the central reader) Contraceptive measures adequate to prevent pregnancy during the study Exclusion Criteria: History of inflammatory disease other than hand EOA including: secondary post-traumatic OA; rheumatoid arthritis; spondylarthropathies; erosion of the ulnar styloid process; psoriatic arthritis; skin psoriasis; erosions of the wrist; fibromyalgia History of gout, pseudogout, or hemochromatosis History of allergic or anaphylactic reactions to monoclonal antibodies History of recurrent or chronic systemic infections Known allergy to acetaminophen Female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding Other protocol-defined inclusion/exclusion criteria may apply
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
PlaceboGroup II
ExperimentalStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 27 locations