Trial | NCT01213017  Report issue

Title

The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients
The Effect of Certolizumab Pegol in Combination With Methotrexate on MRI Synovitis and Bone Edema and Patient Reported Outcomes as Measured Using an Automated Visit Manager System in Moderate to Severe Rheumatoid Arthritis Patients

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    20
The purpose of this study is to determine whether Certolizumab pegol can rapidly reduce the inflammatory changes and inhibit erosions on hand and wrist MRI in patients with active moderate to severe rheumatoid arthritis.
The primary objective of this study is to evaluate the efficacy of CSP used in combination with MTX in patients with active moderate to severe RA by evaluating change from baseline in synovitis and bone edema MRI scores at week 6.
Study Started
Sep 30
2010
Primary Completion
Jan 31
2011
Study Completion
Apr 30
2012
Last Update
Dec 07
2017

Drug certolizumab pegol

400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks

  • Other names: Cimzia

Certolizumab pegol Experimental

Criteria 

Inclusion Criteria:

moderate to severe RA (DAS > 4.4)
at least two swollen and tender joints in one of the hand/ wrist
patients must have failed at least one non-biologic or biologic DMARDs
currently receiving MTX therapy

Exclusion Criteria:

concomitant diseases or pathological conditions that could interfere and impact the assessment of the study treatment
No Results Posted