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OpenTrials
Completed

NCT Number: NCT01213017

The Effect of Certolizumab Pegol on MRI Synovitis and Bone Edema in Rheumatoid Arthritis Patients

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Arthritis and Rheumatic Disease Specialties, Aventura, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab pegol

Drug

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

Other names: Cimzia

Primary outcomes

  1. the change from baseline in synovitis and bone edema RAMRIS score.

    Time frame: 6 weeks

Secondary outcomes

  1. the change from baseline in RAMRIS erosion score

    Time frame: 16 and 52 weeks

Sponsors and collaborators

Lead sponsor

Oklahoma Medical Research Foundation

Other

Collaborators

  • UCB Pharma

Registry information

Official study title

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

Acronym: PICS

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Oct 1, 2010
Registry last updated
Dec 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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