Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
Inclusion Criteria:Patients: 1. Clinical diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA) or spondyloarthritis (SPA). 2. Planned or newly started (within 4 weeks before baseline visit) disease-modifying treatment. 3. Disis activity defined as:
- - RA - DAS28 (ESR or CRP) minimum 3.2, - PsA - DAPSA minimum 15, - SPA - BASDAI minimum 4.0.
- - RA - 4/4, - PsA - 2/2, - SPA - not applicable.
Exclusion Criteria:Both patients and controls: 1. Chronic neurologic disorders such as multiple sclerosis, parkinsonism, active epilepsy, symptomatic peripheral neuropathy, sequels after radiculopathy or other central nervous system deficit. 2. Paresis after cerebral stroke (mild deficits or TIA can be allowed). 3. Serious heart failure (NYHA 3 or above). 4. Pregnancy. 5. Active psychotic disorder. 6. Activ alcohol or drug addiction. 7. Fast use of medicine that can significantly influence CNS function (low dose sleeping medicine 12 hours before a visit can be allowed). 8. Spinal compression fractures less than six months before baseline. 9. Other limb fractures, within 4 months before baseline if it can influence patient's mobility. 10. Other medical conditions that can influence patient's mobility
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Pawel Mielnik, MD, PhD|
|Principal Investigator Affiliation||Helse Forde|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Arthritis, Rheumatoid, Spondyloarthritis, Psoriatic Arthritis|
Study type: Observational, proof-of-concept. Objectives: Primary objective: To evaluate if an accelerometer signal in patients with active arthritis differs from the signal taken in inactive arthritis and healthy individuals. Secondary goals:
- - To evaluate how the accelerometer signal differs depending on the disease activity status.
- - To elaborate the methods for analysing accelerometry in the arthritis patients.
- - To build knowledge and data for future studies.
- - To evaluate software and hardware used.
: Arthritis patients
It is not planned any intervention. The patients' group will be invited to 4 visits.
: Healthy controls
No intervention planned. Only one visit will be conducted.
Other: - Akcelerometry follow up
The patients and control group will be followed up with single accelerometer.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.