Ultrasonography Clinical Trial
— ULSPABITOfficial title:
Longitudinal ULtrasonographic Study of Patients With Spondylarthritis Starting First Time or Switching to a New Biological Therapy; the ULSpABiT Study.
NCT number | NCT01219257 |
Other study ID # | 011110 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2011 |
Est. completion date | January 2016 |
Verified date | August 2022 |
Source | Diakonhjemmet Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Patients with spondylarthritis (SpA) (including ankylosing spondylitis, psoriatic arthritis, arthritis as part of inflammatory bowel disease and reactive arthritis) have axial involvement (the spine) as well as peripheral inflammation in joints and entheses (where the tendons and ligaments are anchored to the bone). Patients with high disease activity of SpA may need biological treatment (anti-TNF alpha), which are very expensive medications. Thus it is necessary to have a sensitive method for assessing the response to treatment. Ultrasonography (US) is a validated and reliable method for assessing disease activity in joints and tendons, and may be used to follow the treatment response. The present study will include patients with SpA starting on anti-TNF alpha treatment (as first biologic medication or when switching to a new biologic treatment). The study is an extension of the ongoing NORDMARD study (Norwegian longitudinal observational study of arthritic patients starting disease-modifying treatment). The patients will be examined by use of US of 38 joints and 14 entheses at baseline and after 3, 6 and 12 months. The objectives are to explore US as a method to assess peripheral inflammatory activity for evaluation of response to medication as well as to compare the US pathology with clinical and laboratory findings.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - SpA - Planning to start anti-TNF alpha treatment Exclusion Criteria: - Patients not being able to communicate in Norwegian or not being able to fill in questionnaires - Surgery in more than 5 of the joints/entheses to be examined by US |
Country | Name | City | State |
---|---|---|---|
Norway | Department of Rheumatology, Diakonhjemmet Hospital | Oslo |
Lead Sponsor | Collaborator |
---|---|
Diakonhjemmet Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the sensitivity to change of US pathology in joints and entheses in SpA patients starting biological treatment. | The joints will be assessed according to a US atlas by use of a semi-quantitative (0-3) scoring system and the entheses will be evaluated according to internationally accepted scoring methods. | Including patients for about 1.5 years | |
Secondary | 1. Explore whether the US (B-mode and power Doppler) scores at baseline or after 3 months predict patients responding to biological treatment after 6 and 12 months. | 2.5 years | ||
Secondary | 2. Explore whether the sensitivity for change is higher for US (B-mode and/or power Doppler) than for the traditional assessments for inflammatory activity. | 2.5 years | ||
Secondary | 3. Explore potential differences of US detected pathology in joints and entheses between subgroups of spondylarthritis patients. | 2.5 years | ||
Secondary | 4. Explore whether the different subgroups of spondylarthritis patients have different US response (B-mode synovitis and power Doppler in joints and entheses) to biological treatment. | 2.5 years | ||
Secondary | 5. Explore the association between the US findings (BM and/or PD) and the patient's experience of pain and fatigue. | 2.5 years | ||
Secondary | 6. Explore the associations between calprotectin and US detected inflammation in joints and/or entheses as well as traditional assessments of disease activity. | Calprotectin, a major granulocyte protein, is assessed by use of ELISA in plasma. Plasma samples will be frozen at all visits, and the calprotectin assessments will be performed when all patients have finished the study. | 2.5 years | |
Secondary | 7. Explore whether baseline calprotectin or other biomarkers in blood may predict response to biological medication. | Plasma and serum will be frozen at each visit, and the S100 proteins calprotectin as well as A12 will be assessed. In addition, other relevant biomarkers may be analyzed after 2.5 years. | 2.5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04095143 -
Ultrasound Markers of Organ Congestion in Severe Acute Kidney Injury
|
||
Recruiting |
NCT05114551 -
ICU Predictive Score of WEaning Success in Patients At Risk of Extubation Failure
|
||
Completed |
NCT04853290 -
Patient Experience in Peripheral Venipuncture With and Without Ultrasound
|
N/A | |
Completed |
NCT04853264 -
Ultrasound Guided Peripheral Catheterization Increases First-attempt Success Rate
|
N/A | |
Recruiting |
NCT02556541 -
Ultrasound-guided Peripheral Vascular Access in Children
|
N/A | |
Completed |
NCT02801058 -
Ultrasound Evaluation of Changes in Diaphragm Induced by Osteopathic Manipulative Techniques
|
N/A | |
Recruiting |
NCT01282528 -
Ultrasonographic Monitoring of Response to Infliximab in Patients With Rheumatoid Arthritis
|
Phase 4 | |
Not yet recruiting |
NCT05036460 -
Real-time Sonography in Detecting Inadvertent Esophageal Intubation Among Difficult Intubation Patients
|
N/A | |
Completed |
NCT04114812 -
Near-peer Tutoring Compared With a Standard Faculty-led Course for Undergraduate Training in Abdominal Ultrasound.
|
N/A | |
Completed |
NCT05519358 -
Midsagittal Tongue Measurement to Predict Difficult Airways
|
||
Completed |
NCT02741453 -
Bilateral Internal Jugular Veins Ultrasound Scanning Prior to CVC Placement
|
N/A | |
Recruiting |
NCT06255808 -
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
|
||
Not yet recruiting |
NCT06001242 -
The Relationship Between Upper Extremity Explosive Power and Trunk Muscles in Volleyball Players
|
||
Completed |
NCT03316352 -
Ultrasound-assisted Versus Conventional Landmark-guided Paramedian Spinal Anesthesia in Elderly Patients
|
N/A | |
Completed |
NCT03764111 -
Comparing an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System
|
||
Completed |
NCT00971750 -
Laparoscopic Versus Transabdominal Ultrasound in Morbidly Obese Patients
|
N/A | |
Completed |
NCT03314519 -
Lung Ultrasonography vs Fiberoptic Bronchoscopy for Aiding Lung Collapse in Patient Using Double Lumen Tube
|
N/A | |
Completed |
NCT03697902 -
Influence of Imaging Angle in Measurement of Cisterna Magna
|
||
Not yet recruiting |
NCT05497661 -
Ultrasound Patellar Tendon Assessment
|
N/A | |
Completed |
NCT04823637 -
Evaluating for a Correlation Between Osteopathic Examination and Ultrasonography on Thoracic Spine Asymmetry
|