Clinical Trials Logo

Clinical Trial 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).


Clinical Trial Description

Rheumatoid arthritis (RA) is a chronic inflammatory joint disease. Patients typically experience pain, functional impairment and reduced quality of life, and are at risk of developing progressive joint damage. The disease primarily affects the small joints of the hands and feet. The current treatment strategy involves early and intensive treatment with close clinical follow up, which attempts to control the disease and avoid inflammation and thereby prevent pain, improve functional level and avoid joint damage. It is therefore important for optimal treatment of RA patients that methods used for diagnosis, disease monitoring and prognostication are highly sensitive. Erosive joint damage occurs early in the disease. Joint deformity is irreversible and causes serious functional impairment. Early and intensive treatment with close monitoring of the inflammation can slow the destructive disease and prevent function loss. However, it has been demonstrated that patients who are shown by conventional clinical and biochemical examination to have low disease activity or to be in remission can still have progressive joint damage. This demonstrates that current clinical/biochemical methods used in daily clinical practice are not sufficiently sensitive and other methods are required for the monitoring of disease activity and prognostication.

The presence of erosions (shown by X-ray examination) as well as anti-cyclic citrullinated peptide (anti-CCP) antibodies and bone marrow oedema (osteitis) on magnetic resonance imaging (MRI), are all independent predictors of subsequent radiographic progression. Bone marrow oedema has been shown to be the strongest independent predictor in early RA and MRI therefore has significant prognostic value.

It is therefore possible that supplementing conventional clinical and biochemical examinations of RA patients with MRI, and intensifying treatment where bone marrow oedema is present, will help reduce disease activity, avoid progressive joint damage and prevent function loss.

The current study is therefore based on the following hypothesis:

By supplementing conventional clinical and biochemical examination of RA patients with low disease activity/in remission with MRI and intensifying treatment in the case of sub-clinical inflammation as measured by the presence of bone marrow oedema, it is possible to prevent radiographic erosive progression, improve functional level and enable more patients to achieve clinical remission. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01656278
Study type Interventional
Source King Christian X´Hospital for Rheumatic Diseases
Contact
Status Completed
Phase N/A
Start date March 2012
Completion date May 2017

See also
  Status Clinical Trial Phase
Terminated NCT01682512 - Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis Phase 3
Completed NCT00539760 - A Phase I Rheumatoid Arthritis Study in Healthy Volunteers Phase 1
Active, not recruiting NCT03312465 - Anatomical Shoulder Domelock System Study
Completed NCT01208181 - A Two-Part, 12-Week Study of Etoricoxib as a Treatment for Rheumatoid Arthritis (RA) (MK-0663-107) Phase 3
Completed NCT03254810 - Comparison of the Safety and PK of SYN060 to Humira® in Healthy Adult Subjects Phase 1
Completed NCT01711814 - A Study to Evaluate the Long-term Safety and Efficacy of ASP015K in Subjects Previously Enrolled in a Phase 2 ASP015K Rheumatoid Arthritis Study Phase 2
Completed NCT03315494 - Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SKI-O-703 in Healthy Volunteers Phase 1
Withdrawn NCT03241446 - Pharmacokinetics and Dosimetry of Tc 99m Tilmanocept Following a Single Intravenous Dose Administration in Male and Female Subjects Diagnosed With Rheumatoid Arthritis (RA) Phase 1
Completed NCT02553018 - Comparison of Compliance and Evolution of Functional Capacity of Patients With Rheumatoid Arthritis Treated by Methotrexate Either by Auto-injector or by Conventional Sub-cutaneous Syringe Phase 3
Completed NCT02748785 - MTX Discontinuation and Vaccine Response Phase 4
Active, not recruiting NCT02260778 - Treat-to-target in RA: Collaboration To Improve adOption and adhereNce N/A
Completed NCT02569736 - Characterization of the Effect of Tocilizumab in Vivo and in Vitro on T Follicular Helper Cells in Rheumatoid Arthritis Patients and Consequence on B Cells Maturation
Completed NCT01750931 - This Study is Randomised, Single Oral Dose Bioequivalence Study of Meloxicam GSK 15 MG Tablets. Phase 2
Not yet recruiting NCT01154647 - Pain Inhibition in Patients With Rheumatoid Arthritis and Central Sensitivity Syndromes N/A
Withdrawn NCT01204138 - Concomitant Use of Apremilast for the Treatment of Active RA Despite TNF-Inhibition and Methotrexate- CATARA Phase 2
Completed NCT00973479 - An Effectiveness and Safety Study of Intravenous Golimumab in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate Therapy Phase 3
Completed NCT00975130 - Subcutaneous Golimumab (GLM) Plus DMARDs for Rheumatoid Arthritis, Followed by Intravenous/Subcutaneous GLM Strategy (P06129 AM2) Phase 3
Completed NCT00913458 - Study Evaluating Etanercept Plus Methotrexate in Early Rheumatoid Arthritis Phase 4
Completed NCT00550446 - A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis Phase 2
Completed NCT00660647 - Optimized Treatment Algorithm for Patients With Early Rheumatoid Arthritis (RA) Phase 3