Arthritis, Rheumatoid Clinical Trial
Official title:
Does an MRI-guided Treatment Strategy Reduce Disease Activity and Progression in Patients With Rheumatoid Arthritis (RA): a Randomised Controlled Trial
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).
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.
;
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 |
NCT02748785 -
MTX Discontinuation and Vaccine Response
|
Phase 4 | |
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 | |
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 |