An MRI-guided Treatment Strategy to Prevent Disease Progression in Patients With Rheumatoid Arthritis

Summary

The purpose of this study is to examine whether an magnetic resonance imaging (MRI) -guided treatment strategy based on a predefined treatment algorithm can prevent progression of erosive joint damage, increase remission rate and improve functional level in the short and long term in patients with rheumatoid arthritis (RA).

Conditions

• Arthritis
• Arthritis, Rheumatoid
• Joint Diseases
• Musculoskeletal Diseases
• Rheumatic Diseases
• Connective Tissue Diseases
• Autoimmune Diseases

Interventions

PROCEDURE

Magnetic resonance imaging (MRI)

Treatment algorithm based on conventional biochemical/clinical examinations AND MRI of unilateral 2nd to 5th MCP joints and wrist on dominant side. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one physically swollen joint and DAS28\>3.2 AND/OR MRI-detected bone marrow oedema score \> 0 (RAMRIS-score)

OTHER

Conventional biochemical and clinical examinations

Treatment algorithm based on conventional biochemical and clinical examinations. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of "unsatisfactory inflammatory activity", which is defined as the presence of at least one clinically swollen joint and DAS28\>3.2

Sponsors & Collaborators

• King Christian X´Hospital for Rheumatic Diseases

  collaborator OTHER

• Slagelse Hospital

  collaborator OTHER

• Glostrup University Hospital, Copenhagen

  collaborator OTHER

• Abbott

  collaborator INDUSTRY

• Professor of Rheumatology, MD, DMSci, Kim Horslev-Petersen

  lead OTHER

Principal Investigators

• Kim Hørslev-Petersen, Professor · King Christian X´Hospital for Rheumatic Diseases

• Signe Møller-Bisgaard, MD · Dep. of Rheumatology, Rigshospitalet, Glostrup

• Mikkel Østergaard, Professor · Dep. of Rheumatology, Rigshospitalet, Glostrup

• Bo Ejbjerg, MD, PhD · Dep. of Rheumatology Slagelse Hospital

• Merete Hetland, MD, PhD, DMSci · Dep. of Rheumatology, Rigshospitalet, Glostrup

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-03-31

Primary Completion

2017-05-31

Completion

2017-05-31

Countries

• Denmark

Study Locations